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Dimana membeli koin emas di India Bila Anda berpikir untuk membeli koin emas 8211, tempat pertama yang terlintas di benak Anda mungkin adalah perhiasan lokal, tapi ada lebih banyak pilihan daripada yang Anda inginkan, jika Anda ingin membeli koin emas. Dalam posting ini saya akan melihat beberapa pilihan itu. 1. Beli koin emas di bank. Banyak bank India menjual koin emas akhir-akhir ini. Keuntungan membeli koin emas dari bank terkenal adalah Anda memiliki lebih banyak ketenangan pikiran, sejauh kualitas koin emas pergi. Kerugian membeli emas dari bank adalah bahwa mereka biasanya mengenakan premi pada koin emas, dan Anda mungkin akan membayar lebih dari yang seharusnya Anda bayar di toko perhiasan. Kelemahan lainnya adalah bahwa biasanya bank tidak membeli kembali emas dari Anda. Jika Anda membeli emas dari toko perhiasan terkenal, maka dalam kebanyakan kasus mereka akan membelinya kembali dari Anda. 2. Beli koin emas di kantor pos: Ini mungkin mengejutkan Anda, dan tentu saja mengejutkan saya, tapi memang benar bahwa Kantor Pos India menjual koin emas. Mereka juga mengenakan premi pada koin emas yang mereka jual, tapi nampaknya harganya kurang dari yang dikenakan oleh bank. Saya tidak yakin tentang ini meskipun, dan yang terbaik adalah untuk memeriksa titik ini sendiri. Seperti bank, Kantor Pos tidak akan membeli emas itu dari Anda, dan hanya beberapa kantor pos yang diizinkan menjual koin emas, jadi pilihan ini mungkin bahkan tidak praktis untuk Anda. 3. Beli koin emas secara online: Saya melihat setidaknya beberapa situs web yang menjual koin emas secara online, dan itu sepertinya sah. Saya tidak terhubung dengan mereka karena saya tidak bisa membaca ulasan apapun tentang mereka, dan tidak tahu ada orang yang telah membeli koin emas secara online di India. Selanjutnya, ketika saya mengecek harga koin emas 2 gram di situs mereka dan membandingkannya dengan koin emas yang dijual SBI, 8211 saya menemukan bahwa toko online tersebut mengenakan harga yang lebih tinggi. Toko online itu meminta Rs. 3998 untuk koin emas murni 2 gram 99, sedangkan harga yang saya lihat di SBI adalah Rs. 3.760. Hal ini tidak masuk akal bagi saya, dan secara pribadi, saya lebih suka pergi ke bank dan membeli koin emas, daripada membayar ekstra ke pengecer online untuk membeli koin emas. 4. Beli koin emas dari pengecer nasional seperti Tanishq: Anda bisa pergi ke toko perhiasan terkenal bereputasi seperti Tanishq, dan bisa membeli koin emas atau jeruji dari mereka. Ini menawarkan ketenangan pikiran karena mereka memiliki reputasi yang kuat, dan distribusi bagusnya berarti ini akan menjadi pilihan yang tepat bagi banyak dari Anda. 5. Beli koin emas dari toko perhiasan lokal Anda: Sebagian besar orang India akan memiliki perhiasan keluarga, dan jika mereka menjual koin emas atau jeruji besi, Anda mungkin merasa ini adalah pilihan termurah. Selanjutnya, mereka juga bersedia membeli 8211 koin emas itu, jadi itu adalah keuntungan tambahan untuk membelinya. Ini adalah lima pilihan yang bisa saya pikirkan dari mana Anda bisa membeli koin emas di India, dan saya ingin mendengar apakah ada pilihan yang Anda tahu dan saya tidak terjawab. Lebih dari situs saya Bagaimana menemukan tingkat emas di India Dapatkah saya membeli koin emas di kantor pos Apakah skema monetisasi emas membantu saya jika saya tidak ingin melelehkan emas saya Bagaimana cara membeli koin emas di India Tidaklah benar kantor pos India Jual koin emas lebih murah dari pada bank. Sebaliknya, mereka menjual lebih tinggi sekitar 5-6 lebih. Alasannya tidak jelas. Morever, tarif mereka tidak avialable on line untuk diperiksa oleh pelanggan. Ada kebutuhan untuk memperbaiki batas pada harga maksimal yang bisa dikenakan oleh bank dari koin emas. Saat ini mereka adalah perbedaan 5-6 dalam harga. Selain itu, bank dan kantor pos harus memperkenalkan skema pembelian kembali koin emas mereka, seperti yang dimiliki Tanisque. Ini akan meningkatkan penjualan dan pembelian koin emas. Pemerintah harus berpikir untuk menanamkan koin emasnya sendiri, seperti yang dilakukan oleh Amerika Serikat dan negara-negara maju lainnya. Ya, bank harus membeli kembali skema untuk membuat investasi ini populer. Anda bisa membeli koin emas kemurnian 99,99, yang disertifikasi dan didistribusikan oleh bank dari toko perhiasan lokal dan Anda akan membayar sekitar Rs 1500 kurang dari harga sebenarnya yang dikutip di bank. Perhitungannya berjalan seperti harga pasar sebenarnya dari emas 24 karat pada hari itu pajak Rs 800 1 jika dibawa ke Bangalore. Jika Anda membeli koin emas 22 karat, Anda harus membayar harga pasar sebenarnya dari 22 karat biaya mati emas yang kira-kira Rs 30 per gram atau beberapa orang akan memungut Rs 300, tergantung pada perhiasan lokal Anda. Katakanlah misalnya jika Anda bank mengutip Rs 16,500 untuk koin 8 gm, Anda bisa membeli koin yang sama dari toko perhiasan seharga Rs 14.200. Jika Anda mendapatkan koin 8 g, 22 ct dari toko perhiasan, Anda akan membayar sekitar 12.000. Angka-angka ini hanya mendekati. Semoga ini bisa membantu investasi yang lebih baik Terima kasih atas tipnya Alex. Apakah lebih mudah untuk menjual koin yang dibeli dari toko perhiasan kembali kepada mereka dibandingkan dengan koin yang dibeli di bank Hai, Saya tertarik untuk membeli emas untuk investasi dan baru-baru ini mulai menjelajahi pasar. Temuan Saya: Bank mengenakan premi yang tinggi untuk 24 koin emas Carat Gold, namun sementara perhiasan lokal saya memiliki bank emas yang sama dengan koin emas 24 karat dimana dia membebankan 9 premi (sesuai dengan rujukan RBI 9) 1 yaitu 10 yang mana Ditemukan cukup masuk akal dibanding bank yang preiumnya sangat tinggi. Buyback akan berada pada tingkat emas 24 karat yang berlaku pada hari penjualan. Itu berarti apa yang Anda bayar pada koin Emas adalah 10 restriksi premium adalah pengembalian yang Anda dapatkan kembali pada investasi. Juga ETF Emas yang saya baca di situs ini hanya jika dijual setelah 1 tahun maka keuntungan modal Jangka Panjang LTCG akan berlaku lagi 10 Oleh karena itu saya mencoba membandingkan dua opsi di mana ETF Emas nampak lebih baik untuk hal yang sama. 10 biaya Anda mendapatkan Emas dan Anda tidak perlu membayar biaya loker dan ketegangan penyimpanan. Anda mendapatkan keuntungan dari investasi di Gold tanpa kepemilikan fisik dan ketegangan pengamanan yang sama. Tolong beritahu saya pandangan Anda tentang pemahaman. Hai Sowmya, ini semua adalah pengamatan yang bagus, dan biarkan saya menambahkan beberapa pemikiran kepada mereka: 1. Saat Anda pergi untuk menjual koin emas, Anda mungkin menghadapi beberapa pengurangan tambahan seperti yang dilaporkan oleh orang-orang yang mencoba menjual koin emas Tanishq, jadi Anda perlu Untuk menjaga faktor itu dalam pikiran sambil melihat emas fisik. 2. ETF Emas memiliki biaya sekitar 1 dari aset untuk yang lebih rendah, jadi ini sama dengan biaya penyimpanan, dan Anda bisa memikirkan uang ini yang akan dikurangi dari keuntungan Anda, atau meningkat menjadi kerugian Anda. 3. PPN harus dibayar untuk membeli emas fisik. Jadi, ini adalah beberapa faktor tambahan yang bisa Anda evaluasi. Hai Sowmya, saya ingin menambahkan sesuatu pada pernyataan Anda di bawah ini: Juga ETF Emas yang telah saya baca di situs ini hanya jika terjual setelah 1 tahun, maka keuntungan modal Jangka Panjang LTCG akan berlaku lagi 10 untuk Emas Fisik, Anda Harus menunggu selama 3 tahun (berbeda dengan 1 tahun untuk emas demat) agar keuntungan dikenai pajak sebagai Long Term Capital Gain. Keuntungan modal jangka pendek ditambahkan pada pendapatan Anda dalam kedua kasus tersebut. Dengan mengatakan 8216 menunggu dengan sabar8217 iam tidak berarti 1 atau 2 tahun. Jika Anda melihat pasar saham bergerak dalam siklus.1 0r 2 tahun mungkin turun. Tetapi setelah itu Anda akan mendapatkan keuntungan lebih dari 3 kali juga. Anda telah membeli emas dan mengambil pinjaman dan berinvestasi dalam reksadana ekuitas Anda akan melipatgandakan uang Anda dan nilai emas juga meningkat. Sekarang Anda bisa menjual emas dengan harga tinggi. Dan membayar kembali pinjamannya. Apa yang Anda dapatkan dari reksa dana? Adalah bonus Namun, selalu ada hal yang baik untuk rencana Anda. Lebih baik beli koin emas dan ambil pinjaman dengan menggunakan itu dari bank. Minat maksimumnya adalah 1,5 pm. Investasikan hal yang sama di reksa dana cair. Bila pernah berbagi pasar turun dengan sangat menginvestasikan sebagian dari jumlah tersebut. Tunggu dengan sabar. Jika Anda mendapatkan jam 3 sore Kembali dengan menarik dan membayar kembali pinjaman. GB 8211 Apa yang akan Anda lakukan jika pasar benar-benar tangki, dan Anda tidak dapat membuat 3 per bulan yang Anda bicarakan Ini adalah strategi yang benar-benar berisiko, dan secara pribadi, yang sama sekali tidak masuk akal bagi saya. Saya telah meneliti pasar emas selama tiga tahun. Saya akan memberitahu Anda hal ini yang tidak saya lihat dari orang India lainnya. ETF emas tidak memiliki emas fisik untuk mendukungnya. ETF adalah turunan, dan itu berisiko. Jika ingin berpartisipasi di pasar bull emas, Anda harus membeli emas fisik, dan tidak pernah membeli sepotong turunan emas ETF. NSEL E-Demat juga omong kosong. Ada terlalu banyak risiko pihak lawan terhadap derivatif ini. Anda harus membeli emas untuk keamanan. Pengecualian adalah jika Anda trading untuk jangka pendek. Tapi Anda seharusnya tidak melakukan perdagangan emas untuk jangka pendek. Jangka pendek terutama untuk pecundang atau pemula. Orang pintar membeli untuk jangka panjang dengan tren. Mungkin ada saatnya di 2,3,4, atau 5 tahun ketika Anda bisa menjual emas Anda. HANYA BELI FISIK EMAS DAN SILVER. Itu tidak benar 8211 ETF emas diharuskan menyimpan emas fisik untuk mendukung pembelian mereka yang juga diaudit. Apa gunanya Anda mengatakan tidak ada emas untuk mengembalikan emas ETF Itu sama sekali tidak benar. ETF emas 100 didukung oleh Emas Fisik di India. Saya pikir Anda berbicara tentang AS, dimana ada dana tertentu yang menggunakan cara turunannya menjadi emas. Syukurlah di India, tidak diperbolehkan. Infact, di India, bahkan donot AMC pun memiliki akses ke emas yang tersimpan di lemari besi. Emas diasuransikan terhadap segala kerugian. Hal ini secara rutin diverifikasi dan diaudit dan diurus oleh kustodian reksa dana Anda, yang biasanya merupakan bank. Penjaga menyimpan emas atas nama investor dan amc. Anda benar tentang ETF emas di A.S. menggunakan derivatif yang menunjukkan bahwa ETF tidak dapat dipercaya. Tapi hal yang sama memang berlaku di India. Lebih. Karena orang di sini secara membabi buta mempercayai bank kustodian. AMC harus memiliki akses ke emas di lemari besi, yang Anda maksud sendiri TIDAK terjadi. Kustodian itu sendiri tidak memiliki emas karena jika mereka melakukannya, mereka akan melepaskan hasil audit, yang tidak dimiliki oleh bank manapun. Ini menunjukkan bahwa ada sesuatu yang mencurigakan dengan ETF. Jadi, jangan pernah mempercayainya. Hanya membeli emas fisik dan sivler. Ini informasi bagus di blog ini. Terima kasih. Pada penjelajahan lebih lanjut, saya menemukan sebuah MMTC yang dikelola oleh Pemerintah yang mengklaim menjual koin dan bar emas namun mereka tidak memiliki outlet di Mumbai. Satu-satunya pilihan terpercaya lain yang bisa saya cari adalah bahwa National Indian Bullion Refinery. Saya masih mencobanya. Jika ada orang yang memiliki pengalaman dengan hal itu yang akan membantu saya dan pembaca lainnya secara langsung. Anda bisa membeli dari emas koin MNC Bullion 99.9 yang sama seperti koin Bank dengan harga yang sangat kompetitif. Saya membeli dari mereka dan saya senang dengan koin dan layanannya. Mereka memberitahu saya bahwa segera mereka akan menjualnya secara online di situs web mereka buyorsellcoin untuk pengiriman di manapun di India Sesuai dengan pos di atas oleh Yash, saya membeli satu perak 100 gram bar dari mncbullion. Saya harus mengatakan bahwa saya terkesan dengan layanan dan koin itu. Premi tersebut mencapai sekitar 16, yang merupakan salah satu pasar perak fisik ritel India terbaik. Tapi hari ini saya tahu tentang Jalan Perhiasan di New Delhi. Mereka memiliki dua cabang: satu di Chandni Chowk dan yang lainnya di Lajpat Nagar. Saya pergi ke Lajpat Nagar karena fasilitas Hallmarking mereka ada di sana. Mereka BIS disetujui untuk Hallmarking. Anda bisa mengecek link ini untuk melihat alamat mereka di atas meja di situs BIS: Sl No. 6. bis.org.incerthallmarkass.htm Premi ternyata sedikit lebih rendah dari Bullish MNC. Plus aku membuat mereka untuk menandai bar. Tampaknya MNC tidak berwenang untuk ciri khas. Tapi jika Anda berbicara dengan mereka, mereka mungkin akan menyukainya melalui pihak ke-3. Saya tidak yakin. Jadi untuk siapapun yang tinggal di Delhi, saya sangat merekomendasikan Jalan Jewellers. Terutama cabang Lajpat Nagar sebagai pusat hallmarking yang berada di sana. Bila Anda membeli katakan kepada mereka bahwa Anda ingin itu ditandai. Saya pikir itu Rs. 50 per item Sekali lagi saya sangat merekomendasikan agar Anda melihat Jalan Jewelers. Mereka juga memasok sebagian ke MMTC dan Muthoot Finance. Bagi mereka yang tidak tinggal di dekat Delhi, mereka bisa membeli dari MNC Bullion, yang juga memberi pelayanan yang bagus. Tapi lagi harganya sedikit lebih tinggi dari Jalan Perhiasan: sekitar 1-2 perbedaan. Tapi jika Anda bisa meminta mereka untuk memberi tanda, itu akan lebih baik. Jadi, pencarian saya untuk membeli perak fisik di Delhi akhirnya berakhir. Pilihan pertama adalah Jalan Jewelers: karena harga, lokasi, hallmarking. MNC Bullion juga merupakan alternatif. Kekuatan Bullish MNC adalah bahwa mereka terkenal di India Selatan dan membeli secara online. Keduanya dikenali dari MCX, dan NSEL. Namun, Jalan Perhiasan juga diakui oleh IBMA. Besar. Terima kasih atas informasi rinci yang saya cari lama ini. Siapa pun yang tertarik untuk membeli emas perak harus melalui blog ini informasi yang bagus. Saya punya banyak ide bagus untuk menghemat uang. Saya telah membeli koin emas 24k dari 8 gram dari toko perhiasan Manappuram. Mereka menuduh saya Rs.151 2 PPN juga. Apakah itu cukup adil? Seberapa jauh Karat meter bisa diandalkan. Saya tahu tentang perusahaan yang menawar emas emas 24 c dengan emas murni 99,9 di dalamnya. Saya pikir muthoot adalah pilihan bagus untuk membeli koin emas. Bagaimana dengan koin emas Reliance Ada orang yang punya pengalaman dengan Reliance. Apakah itu kepercayaan pilihan yang layak Pertanyaan utama ada apakah mereka membelinya kembali dari pelanggan karena pada saat itu orang menghadapi masalah. Saya tidak tahu apakah pelanggan bisa menjualnya kembali kepada mereka, tetapi jika mereka bisa menghadapi beberapa masalah yang sama yang mereka hadapi saat mereka menjual koin emas bank ke toko perhiasan. BTW Tanishq selain harganya yang sangat mahal juga tidak menyatakan premi yang dikenakannya pada koin berbagai denominasi. Semua salesman memiliki cetakan untuk membuat dakwaan dll tapi jika diminta memberikan salinannya, mereka mengatakan itu adalah keputusan kebijakan. HINDARI TANISHQ untuk saya Saya lebih suka TBZ kapan saja saya membeli koin emas di caratlanegold-coins baru-baru ini. Sepertinya situs profesional. Mereka tidak membeli kembali tapi Anda selalu bisa menukar koin dengan perhiasan dengan nilai 100 kapan saja. Mereka juga memiliki kebijakan penjaminan harga Terendah di mana mereka akan memberi kembali Anda dengan perbedaan jika Anda dapat menemukan harga yang lebih rendah di pasar. Terima kasih Sandeep, sudahkah Anda menerima koin itu? Setiap umpan balik tentang berapa lama waktu yang mereka butuhkan untuk menyampaikannya, dan jika Anda berencana untuk mendapatkan kemurnian yang diuji atau hal lain seperti yang saya dapatkan dari koin itu. Butuh waktu sekitar 3 hari untuk pengiriman. KEMITRAAN EMAS PENTING. Halo semua. Saya telah lama-lama berdiskusi dalam diskusi. Semua tampil sangat menarik. Namun, tampaknya juga beberapa blogger, walaupun mungkin mengetahui beberapa aspek Gold and Investment in Gold yang lebih baik, jangan bermaksud memberikan rincian informasi yang lebih lengkap. Boleh saya menambahkan sesuatu disini Sebagai cukup sedikit diskusi adalah pada Koin, saya rstricting diriku ke hal yang sama. Saya tidak bisa melihat ada blogger yang menulis tentang apa pun tentang kemurnian Emas. The 821724 Carat8217 Gold tersedia dalam 3 Purities, jika tidak lebih, 995 Kemurnian 999 Kemurnian dan 9999 Kemurnian. E-Glod yang sedang dibahas oleh Mr. Jain atau Caratlane yang sedang disarankan oleh Pak Sandeep keduanya termasuk 995 Gold Kemurnian. Yang sebenarnya TIDAK 24 Carat Gold. Meski 100 emas murni sangat sulit dicapai, kemurnian tertinggi yang avaialble adalah 9999 Kemurnian 99,99 murni. Jadi, sebenarnya berbicara 24 Carat Gold berarti 9999 Kemurnian. Hari ini pada tanggal 22-06-2011, Harga Jual MMTC8217s untuk Koin Emas 10g 9999 Kemurnian adalah Rs.24.835.00 di Mumbai yang benar-benar diperiksa dan Harga Kematian Emas Kemurnian 995 di Caratlane adalah Rs. 24.015.00 dan di NSEL harga 10g 995 kemurnian E-Gold adalah 23,520.00 seperti yang ditampilkan di situs masing-masing. Tanishq menjual koin 10g 9999 kemurnian hari ini di 26.306.00. Jadi menurut saya Investasi Terbaik adalah membeli emas fisik 9999 kemurnian DAN TIDAK HANYA 24-Carat dari MMTC. Pembaca dapat melakukan penelitian mereka dengan mengunjungi 2 atau 3 showroombanksoutlets pada hari yang sama dan kemudian berbagi dengan pembaca untuk keuntungan semua orang dan tidak membuat blog ini untuk keuntungan mereka sendiri. Sudhir, terimakasih atas komentar anda hanya penasaran untuk mengetahui bagaimana hal ini mempengaruhi harga jual. Apakah perusahaan seperti Tanishq mengurangi lebih sedikit uang sambil membeli emas dengan kemurnian lebih tinggi Terima kasih telah membaca pandangan saya Sebenarnya saya hanya membeli pada saat ini dan belum benar-benar mengumpulkan semua info Tentang penjualan dan rinciannya. Saat ini MMTC tidak membeli kembali koin emasnya. Tapi saat saya mengikuti latihan sekarang untuk membeli dan berbagi info, saya pasti akan berbagi saat saya pergi dan menjual investasi saya. Jadi tidak bisa berkomentar atau membalas kueri sekarang. Namun, dengan kontribusi saya di atas, jika beberapa pembaca dapat menambahkan inouts lebih baik untuk membeli atau menjual keuntungan yang lebih baik, itu akan menguntungkan masyarakat yang lebih besar. Saya memeriksa dengan Spot Exchange, namun keseluruhan prosesnya tampaknya terlalu rumit dan karena itu sulit dilakukan. Saya bertanya tentang penjualan karena di mana orang menghadapi masalah. Jadi, hanya ingin melihat apakah Anda sudah tahu atau tidak. Terima kasih atas komentarmu. Investasi emas adalah kerugian yang lebih baik untuk diinvestasikan dalam depo berjangka bank Anda mungkin ingin juga menyadari perbedaan kemurnian Emas di 24 Karat. Aku baru saja memeriksa Bullion MNC. Yang harganya relatif lebih rendah, namun sadar mereka menawarkan 99,9. Sedangkan harga di mana Anda mungkin menemukan lebih tinggi adalah 99,99 kemurnian. Well i guess yang membuat Bank dan MNC bullion pada tingkat lapangan bermain. Berikut harga hari ini dari berbagai Bank dan Bullish MNC: Ini adalah 99,9 Bullion MNC. Rs. 124387 untuk 50 gms Corp Bank. Rs. 121024 untuk 50 gms Pajak HDFC. Rs. 136178 untuk 50 gram (Mudra emas. Tidak yakin apa bedanya) SBI. Rs. 124500 untuk 50 gram (tidak yakin dengan kemurnian apa yang mereka tawarkan) Gng untuk memeriksa dengan GRT Jwellers dan Tanishq untuk mengetahui tanda petik mereka. Hati-hati terima kasih atas masukan Venkat 8211 kemurnian yang lebih tinggi itu bagus, tapi masalah penjualan membuat saya berpikir lebih baik membeli ETF emas. Tidak tahu berapa banyak mereka akan mengurangi pada saat membeli dari Anda, dan kemudian menciptakan semua jenis kerepotan di atas itu. Itu terlalu mengecilkan hati. Terima kasih untuk semua, saya mendapatkan ide tentang membeli koin emas Saya adalah pelanggan tetap Gold CoinsBars dari MMTC, salah satu pengimpor emas terbesar di India. Satu-satunya batasan adalah MMTC tidak memiliki outlet penjualan selain Metros. Tarif mereka juga cukup atraktif. Bagaimana dengan menjual koin emas Apakah Anda sudah mencobanya, dan apakah mereka membelinya kembali dari Anda Terima kasih banyak atas untaian yang sangat informatif. Pertanyaan yang sangat mendasar. Saya memiliki sedikit emas fisik. Jika emas mencapai (katakanlah) dua kali harganya hari ini atau lebih, kemana saya akan pergi dan menjualnya. Akankah barang-barang perhiasan membelinya kembali dengan harga sama Jika ada tempat lain untuk menjualnya, saya sangat ingin tahu. Informe saya secara berkala Hai, orang tua saya membeli beberapa koin emas dari SBI 2 tahun yang lalu, mereka tidak mengetahui fakta bahwa SBI tidak akan membeli kembali uang logam itu. Mereka membelinya sebagai investasi untuk adik perempuanku. Karena bank-bank tidak akan membeli kembali apa yang dapat mereka lakukan jika mereka ingin mendapatkan keuntungan darinya Mengapa bank-bank yang menjual koin ini jika mereka tidak membelinya kembali Anda bisa membawanya ke toko perhiasan dan menjualnya di sana atau membuat mereka membuat perhiasan. . Itu tentang satu-satunya hal yang dapat Anda lakukan dengannya. Anda harus bertanya di beberapa toko perhiasan untuk melihat siapa yang memberi Anda tingkat terbaik dan sedikit deduksi. Bank yang tidak membeli kembali emas mereka telah menjadi sakit kepala yang hebat karena banyak orang berada dalam perahu yang sama dengan orang tua Anda. Bank dipercaya sebagai sumber untuk membeli koin emas. Dengan melakukan sedikit analisis kita bisa menghemat banyak uang. Kita harus membandingkan suku bunga di antara beberapa bank dan memilih bank yang menjual koin dengan harga lebih baik. Misalnya hari ini (6/6 2011), emas 10 gram di bank Andhra berharga 30.321,00 namun dimana HDFC Bank laku di 34,001.00. Bedanya hampir 700 Rs. Situs ini coziiegold-coin-rates memberikan laporan perbandingan yang bagus. Ada yang bisa bilang mana tempat terbaik 2 beli emas di Bangalore. Terimakasih untuk info bisakah anda beritahu saya manshu dari mana saya bisa membeli koin emas termurah dan kemana saya bisa menjualnya lagi. Saya baru mengenal pasar ini. Jika Anda ingin membeli koin emas di Bangalore, sarankan pergi ke toko perhiasan Shubh 8211 mereka mendapatkan emas dari ekspor Rajesh (eksportir emas dan perhiasan terkemuka di India). Shubh tidak mengenakan biaya tambahan selain biaya pembuatan 1tax8230no dan lain-lain. Juga, kebijakan pembelian kembali mereka cukup bagus karena juga setiap gram emas 24 karat ... mereka mengurangi INR 51 pada tingkat day8217 itu. Saya telah mencobanya dan maaf untuk mengatakan bahwa klaim mereka tentang tuduhan tidak benar8221 salah. Jika Anda membandingkan dengan tingkat emas yang berlaku di pasar Bangalore, mereka mengenakan biaya tinggi, umumnya tarif mereka untuk 22 K kira-kira sama dengan tingkat 24 K pasar. Dengan ini mereka mengisi sekitar 10 lebih dari yang ditunjukkan dalam iklan. Silakan periksa lagi dan tulis umpan balik Anda. Can anyone please advise, tempat bst untuk membeli emas dari faridabad Hai, Jangan pernah membeli dari bank Anda akan membayar jauh lebih tinggi dari harga pasar .. Tukang perhiasan jika percaya satu maka bisa maju tapi lagi akan berakhir membayar lebih anyways kurang dari bank . Coba di sini saya merasa tempat terbaik untuk membeli emas fisik (selalu bagus untuk memilikinya di tangan daripada kertas) Pabrik Kilang Kuat Bangalore, kilang 8221Bangalore hari ini diakui untuk menyempurnakan hampir 95 dari total emas yang ditambang di India8221 Mereka memperbarui harga emas harian setiap hari. Dari semua info diatas saya amati bahwa membeli dari salah satu Bank atau Kantor Pos tidak layak lagi kita harus maju dengan membelinya berbentuk perhiasan jika itu adalah emas fisik Tolong tambahkan ke info saya apa sebenarnya Glod ETF Bagaimana kita bisa membelinya dan apa Adalah unit minimum yang satu harus membeli apa biaya lainnya selain tingkat pasar mereka seperti pada tanggal pembelian Dimana untuk mengakses info lebih lanjut pada saat yang sama Jika kita ingin mengubah yang sama di Emas fisik maka bagaimana cara melakukannya? Kami ingin mendapatkan perhiasan yang sama dengan pembuatan Alka 8211 ETF emas adalah produk elektronik seperti saham yang kemudian menyimpan emas. Anda bisa mengubahnya menjadi emas yang pernah ada. Anda harus membeli dan menjualnya di bursa dan itu adalah barang sejenis reksa dana jenis apa saja yang memiliki emas dan harganya bergerak seperti emas. Hai Manshu, itu tidak benar lagi. Saya bertemu dengan berita baru-baru ini (1 bulan), bahwa sekarang Anda dapat melakukan pengiriman fisik, jika nilai EFT berjalan di atas 8 gms. Sebelumnya itu 1 kg. Tidak bisa mendapatkan referensi artikel berita. Namun, saya menemukan artikel ini dari hdfc, memberi inti pada ETF Emas, kecuali bagian pengiriman physcial. HdfcsecdatadocseducationSampattiGoldETFsimplified.pdf Tidak ada Venkat yang tidak mungkin saya duga. Siapa yang akan memberi Anda unit untuk emas ETF yang menjual di bursa saham adalah unit sekunder yang orang-orang menyukai Anda dan saya berdagang. Dana tersebut menciptakan unit seharga satu kilo dan kemudian mereka diperdagangkan di bursa oleh orang seperti Anda dan saya, jadi kecuali Anda memiliki banyak unit yang tidak dapat Anda gunakan untuk membeli dan menukarkannya. 8 gram sangat sedikit bila harus menukarnya dengan emas, dan karena biaya 1 unit tidak akan pernah benar-benar mewakili 1 gram gram 8211 secara keseluruhan akan sedikit lebih rendah. Saya pikir Anda perlu memeriksa ulang sumber Anda. Tautan yang Anda kirim tidak terlalu membantu sejauh memahami mekanisme penciptaan dan penebusan ETF yang bersangkutan, itulah yang sedang kita bicarakan saat ini. Gitansh, yang Anda tawarkan adalah ilegal Venkat 8211 terima kasih telah menunjukkan komentar ini dan membawanya ke perhatian saya. Saya akan menghapusnya. Hukum farmasi pemula Dari Rx-wiki Selama lebih dari satu abad, undang-undang federal telah berdampak pada praktik apotek. Hampir di setiap kasus, tujuan undang-undang ini adalah untuk melindungi kesehatan, keselamatan, dan kesejahteraan pasien dari potensi risiko penggunaan narkoba atau penyalahgunaan. Sebagian besar undang-undang federal ini telah dimulai untuk menanggapi isu dan masalah pada titik waktu tertentu. Misalnya, Federal Food, Drug, and Cosmetic Act (FDCA) disahkan oleh Kongres sebagai perhatian keselamatan karena kematian lebih dari 100 individu yang mengonsumsi produk obat yang mengandung antibeku. Tindakan lain yang diikuti juga merupakan hasil dari masalah signifikan dengan implikasi nasional. Sementara mendefinisikan praktik farmasi dan mengatur profesi terutama diserahkan kepada masing-masing negara berdasarkan Amandemen Kesepuluh Konstitusi, pemerintah federal mengatur distribusi obat melalui Klausul Perdagangan Interstate. Peraturan tentang distribusi obat ini sering berakibat, baik secara langsung maupun tidak langsung, dalam pengaturan profesi apotek juga. Pemerintah federal juga telah menerapkan undang-undang yang mempengaruhi praktik farmasi berdasarkan partisipasi dalam program Medicaid tersebut. Ketentuan konseling dari Undang-Undang Rekonsiliasi Anggaran Omnibus, walaupun tidak secara langsung mensyaratkan tindakan apoteker, memang mengharuskan pemerintah negara bagian individu untuk menetapkan standar praktik yang diperluas atau berisiko kehilangan dana federal untuk program mereka. Akibatnya, pendekatan pintu belakang untuk mengatur profesi dimanfaatkan. Selama bertahun-tahun, sebagian besar undang-undang federal yang telah disahkan oleh Kongres telah membuktikan dirinya berguna dengan memberikan keamanan dan keamanan yang masyarakat kita harapkan. Apoteker telah memeluk undang-undang ini, meskipun kadang-kadang dengan enggan, karena kebanyakan undang-undang telah menerapkan persyaratan baru di bidang pencatatan, penyuluhan, dan kemasan obat-obatan. Membuat undang-undang federal Ini adalah proses legislatif yang ditetapkan oleh Presiden Franklin D. Roosevelts administrasi New Deal pada tahun 1935. Di bawah sistem kami saat ini kami memiliki dua rute utama di mana undang-undang federal dapat menjadi undang-undang: Kongres AS (Dewan Perwakilan Rakyat dan Senat ) Mengeluarkan undang-undang yang menyatakan tujuan untuk dipenuhi, atau agen federal memutuskan untuk membuat atau memodifikasi peraturan untuk memenuhi situasi baru. Pemberitahuan lanjutan tentang pembuatan peraturan yang diusulkan dan atau peraturan yang diusulkan dipublikasikan di Federal Register (FR). The Federal Register adalah jurnal resmi pemerintah federal Amerika Serikat yang berisi publikasi paling rutin dan pemberitahuan publik dari instansi pemerintah. Ini adalah publikasi harian kecuali hari libur. Setelah melihat dan berdiskusi publik, setiap modifikasi peraturan juga dipublikasikan di FR, dan akhirnya peraturan terakhir akan dipublikasikan di FR. Begitu peraturan dibuat resmi, kode tersebut akan dikodifikasikan ke dalam edisi berikutnya dari Kode Peraturan Federal (CFR). Sementara peraturan baru terus menjadi efektif, volume cetak CFR hanya dikeluarkan setiap tahun. Undang-undang Makanan dan Narkoba yang Murni tahun 1906 Presiden Theodore Roosevelt menandatangani Undang-Undang Makanan Murni dan Obat-obatan setelah disahkan oleh Kongres pada tanggal 30 Juni 1906. Akte Makanan dan Obat Murni asli (juga dikenal sebagai Wiley Act) disahkan oleh Kongres pada bulan Juni 30, 1906 dan ditandatangani oleh Presiden Theodore Roosevelt. Ini melarang perdagangan antarnegara dalam makanan dan minuman yang disalahgunakan dan dipalsukan, minuman dan obat-obatan terlarang di bawah perampasan produk yang dipertanyakan dan atau tuntutan pihak-pihak yang bertanggung jawab. Untuk mendefinisikan beberapa istilah, salah menafsirkan sesuatu berarti memberi label atau label secara menyesatkan atau menipu sementara, cara yang dipalsukan untuk membuat tidak murni dengan menambahkan bahan yang tidak tepat atau inferior. UU Pemeriksaan Daging juga disahkan pada hari yang sama. Pengungkapan yang mengejutkan tentang kondisi tidak sehat di pabrik pengemasan daging, penggunaan pengawet dan pewarna beracun pada makanan, dan klaim obat-obatan untuk obat-obatan paten yang tidak berharga dan berbahaya adalah masalah utama (dibawa ke perhatian publik melalui wartawan yang dikenal sebagai muckraker) yang mengarah ke Berlakunya undang-undang ini. Dua dari muckraker paling terkenal adalah seorang jurnalis bernama Samuel Hopkins Adams (yang menulis serangkaian sebelas artikel untuk Colliers Weekly, yang disebut The Great American Fraud) dan seorang penulis dan aktivis sosial bernama Upton Sinclair (yang menulis The Jungle) Berikut ini adalah beberapa Kasus pengadilan penting yang melibatkan Akte Makanan dan Narkoba Murni: Pada tahun 1911, AS v. Johnson, Mahkamah Agung memutuskan bahwa Undang-Undang Pangan dan Narkoba tahun 1906 tidak melarang klaim terapeutik palsu namun hanya pernyataan palsu dan menyesatkan tentang bahan atau identitas seorang obat. Pada tahun 1912, sebagai reaksi terhadap vonis Johnson A.S., Kongres memberlakukan Amandemen Shirley untuk mengatasi keputusan tersebut di A.S. v. Johnson. Dilarang memberi label obat-obatan dengan klaim pengobatan palsu yang ditujukan untuk menipu pembeli, standar yang sulit dibuktikan. Pada tahun 1924 di A.S. v. 95 Barrels Dugaan Cuka Cuka Apple, Mahkamah Agung memutuskan bahwa Undang-Undang Makanan dan Obat-obatan mengecam setiap pernyataan, perancangan, atau perangkat pada label produk yang dapat menyesatkan atau menipu, bahkan jika secara teknis benar. Kasus ini membantu memverifikasi keberagaman tindakan Murni dan Obat-obatan untuk menangani produk yang salah merek dan dipalsukan. Tindakan ini sering dianggap sebagai awal FDA. Undang Undang Undang Narkotika Harrison 1914 Undang-undang Pajak Narkotika Harrison adalah undang-undang federal Amerika Serikat yang mengatur dan mengenakan pajak atas produksi, impor, distribusi dan penggunaan opiat. Tindakan tersebut diajukan oleh Perwakilan Francis Burton Harrison dari New York dan disetujui pada tanggal 17 Desember 1914 ketika ditandatangani oleh Presiden Woodrow Wilson. Tindakan Untuk menyediakan pendaftaran, dengan kolektor pendapatan internal, dan mengenakan pajak khusus untuk semua orang yang memproduksi, mengimpor, memproduksi, membuat senyawa, menangani, membuang, menjual, mendistribusikan, atau memberikan daun opium atau koka, Garam, turunan, atau olahannya, dan untuk keperluan lain. Tindakan ini dimaksudkan untuk memperlambat meningkatnya jumlah kecanduan opium di AS dan juga untuk mengatasi kekhawatiran mengenai wilayah baru kami di Filipina. Setelah Perang Spanyol-Amerika, A.S. mengambil alih pemerintahan Filipina. Dihadapkan dengan sistem perizinan untuk pecandu opium, Komisi Penyelidikan ditunjuk untuk memeriksa alternatif sistem ini. Komisi Brent merekomendasikan agar narkotika tunduk pada kontrol internasional. Proposal ini didukung oleh Departemen Luar Negeri Amerika Serikat dan pada tahun 1906 Presiden Theodore Roosevelt menyerukan sebuah konferensi opium internasional, yang diadakan di Shanghai pada tahun 1909. Sebuah konferensi kedua diadakan di Den Haag pada tahun 1911, dan dari sana datang yang pertama Perjanjian kontrol obat internasional, Konvensi Opium Internasional tahun 1912, ditujukan terutama untuk memecahkan masalah opium yang disebabkan Inggris di China. Pada tahun 1914, Senat mempertimbangkan tagihan Harrison. Tindakan tersebut didukung oleh Sekretaris Negara William Jennings Bryan yang mendesak agar undang-undang tersebut disahkan untuk memenuhi kewajiban perjanjian internasional yang baru. Perdebatannya adalah tentang kewajiban internasional dan bukan moralitas. Tindakan tersebut tampaknya mengkhawatirkan pemasaran opiat. Namun klausul yang berlaku untuk dokter mengizinkan distribusi hanya dalam praktik profesionalnya. Klausul ini ditafsirkan setelah tahun 1917 yang berarti bahwa seorang dokter tidak dapat meresepkan opiat kepada pecandu, karena kecanduan tidak dianggap sebagai penyakit. Sejumlah dokter ditangkap dan beberapa dipenjarakan. The medical profession quickly learned not to supply opiates to addicts. The impact of diminished supply was obvious by mid-1915. A 1918 commission called for sterner law enforcement. Congress responded by tightening up the Harrison Act the importation of heroin for any purpose was banned in 1924. This act fell under the regulation of the IRS for tax collection and was enforced by the U.S. Department of Justice. Food, Drug, and Cosmetic Act of 1938 Sulfanilamide elixir made by the S.E. Massengill Co. was implicated in the deaths of 107 people in 1937. The Food, Drug, and Cosmetic Act (FDCA) served as a replacement to the Pure Food and Drug Act of 1906. This earlier act prohibited interstate commerce in misbranded and adulterated foods, drinks, and drugs and was most concerned with purity, not safety, issues. In addition, the 1906 act did not prohibit false therapeutic claims and, in some cases, even protected those claims. Furthermore, the 1906 law did little to inform patients as it did not require the label to list ingredients, include directions for use, or provide warnings regarding the product. Because of the shortcomings of the 1906 Act, the FDA petitioned Congress for a new act. Between 1933 and 1937, a legislative battle ensued to replace the 1906 law. On one side of the battle were capitalists calling for laissez faire . on the other were social reformers fighting for government intervention due to concerns over public safety. Ultimately, it was a therapeutic disaster in 1937 that motivated Congress to act. A Tennessee company marketed a sulfa drug in an untested solvent (diethylene glycol) that resulted in the death of 107 people, many of whom were children. The public outcry not only reshaped the drug provisions of the new law to prevent such an event from happening again, but it propelled the bill through Congress. After being passed by both houses of Congress it was signed into law by President Franklin D. Roosevelt on June 25, 1938 The Federal Food, Drug, and Cosmetic Act contains the following new provisions: Extending control to cosmetics and therapeutic devices. Requiring new drugs to be shown safe before marketing-starting a new system of drug regulation. Eliminating the Shirley Amendment requirement to prove intent to defraud in drug misbranding cases. Providing that safe tolerances be set for unavoidable poisonous substances. Authorizing standards of identity, quality, and fill-of-container for foods. Authorizing factory inspections. Adding the remedy of court injunctions to the previous penalties of seizures and prosecutions. This particular act is still the basis of the Food and Drug Administrations authority although it has received various amendments in the past 75 years. The major amendments include: Durham-Humphrey Amendment Kefauver Harris Amendment Medical Device Amendment Orphan Drug Act Drug Price Competition and Patent Term Restoration Act Prescription Drug Marketing Act Dietary Supplements and Health Education Act Food and Drug Administration Modernization Act Best Pharmaceuticals for Children Act Durham-Humphrey Amendment of 1951 This amendment to the Food, Drug, and Cosmetic Act, also known as the Prescription Drug Amendment, was signed into law by President Harry S. Truman on October 26, 1951. This amendment was co-sponsored by former vice president and senator Hubert H. Humphrey Jr. who was a pharmacist in South Dakota before beginning his political career. The other sponsor of this amendment was Carl Durham, a pharmacist representing North Carolina in the House of Representatives. The Durham-Humphrey Amendment, enacted in 1951, resolved the issues left open by the 1938 Act. It established two classes of drugs: Rx legend (prescription) and OTC (over the counter). Prior to the passage of this amendment, drug manufacturers were generally free to determine in which category their drug belonged. A subsection of this amendment granted the FDA the authority to categorize prescription drugs as those that are habit-forming, unsafe for use except under the supervision of a health care practitioner, andor subject to the new drug application approval process. This amendment provided the requirement for either a written prescription from a physician or an oral prescription from the physician that is immediately reduced to writing. Along with this, authorization of refills on prescriptions were made legal. Up until this point, prescriptions were treated like canceled checks and therefore after being filled were considered void. This refill provision made great sense when considering maintenance medications. Additionally, under this amendment, a drug manufacturer can switch their product from Rx to OTC status by doing any one of the following: The drug manufacturer can request the switch by submitting a supplemental application. The drug manufacturer can petition the FDA for the switch And the primary mechanism for switching drugs to OTC is for the drug manufacturer to go through the OTC process, and a review board which the FDA would have to agree to. If the FDA agrees, a final report switching from a prescription drug to OTC drug takes place. The amendment also gave guidance as to what minimal information must be included on the prescription label: name and address of the pharmacy, serial number of the prescription, date of its filling, the name of the prescriber, the name of the patient, the directions for use, and any applicable warning labels. Kefauver-Harris Amendment of 1962 Phocomelia is a congenital malformation of development where the upper appendage of an arm or leg is absent so the hands or feet are attached to the body like stumps. The word phocomelia combines phocodenoting seal and meliadenoting limb to signify a limb like a seals flipper. The Kefauver-Harris Amendment (also known as the Efficacy Amendment ) was the first major update to the FDCA since the Durham-Humphrey Amendment 11 years earlier. Thalidomide disaster and Francis Kelsey 1962: Frances Kathleen Oldham Kelsey receiving the Presidents Award for Distinguished Federal Civilian Service from President John F. Kennedy Thalidomide was developed by a German pharmaceutical company named Grnenthal and was launched for public use in Germany on October 1, 1957. Within 4 years it had been approved for use throughout most of Europe, Africa, and Canada. It was used as a tranquilizer and painkiller, and was proclaimed a wonder drug for insomnia, coughs, colds, and headaches. It was also used as an antiemetic that has an inhibitory effect on morning sickness, so thousands of pregnant women took the drug to relieve their symptoms. At the time of the drugs development, most scientists did not believe any drug taken by a pregnant woman could pass across the placental barrier and harm the developing fetus. Francis Kelsey, Ph.D. was hired to work for the FDA in 1960 and the first drug she was asked to review for approval was thalidomide. Back in the 1940s Dr. Kelsey had been doing research to try and find a synthetic cure for malaria. While not discovering a cure, she did notice that some of the drugs they were studying actually crossed the placenta. Considering that thalidomide was being used in pregnant women as an antiemetic she wanted to see more research done on this possibility with respect to thalidomide before she would approve it. Grnenthal was not happy with her resistance to approving the medication, but she was vindicated when children being born with birth defects were linked back to the use of thalidomide. From 1956 to 1962, approximately 10,000 children were born with severe malformities, including phocomelia, because their mothers had taken thalidomide during pregnancy. As a result of her blocking FDA approval of thalidomide in the United States, Kelsey was honored the Presidents Award for Distinguished Federal Civilian Service by President John F. Kennedy, becoming the second woman to receive that award. After receiving the award, Kelsey continued her work at the FDA. There she played a key role in shaping and enforcing the 1962 Amendments. She also became responsible for directing the surveillance of drug testing at the FDA. Kelsey finally retired from the FDA in 2005, at age 90, after 45 years of service. What this amendment accomplished Among other things, the amendment requires drug manufacturers to show the effectiveness of their products as well as their safety, to report adverse events to the FDA, and to ensure that their advertisements to physicians disclose the risks as well as the benefits of their products. Informed consent was required from participants in clinical studies. The FDA also was given jurisdiction over prescription drug advertising. In addition, the agency was required to approve a regulatory submission known as a new drug application before a company could market a new drug and be allowed to issue good manufacturing practice guidelines governing how drugs were to be manufactured. Inspection of drug manufacturers was mandated every 2 years. The law was signed by President John F. Kennedy on October 10, 1962. The Kefauver-Harris Amendment provided the modern scenario for approving new drugs: Initial drug discovery. Preclinical (animal) testing. An investigational new drug application (IND) outlines what the sponsor of a new drug proposes for human testing in clinical trials. Phase 1 studies (typically involves 20 to 100 healthy people). Phase 2 studies (typically involves 100 to 500 people with the ailment that the new drug is intended to treat). Phase 3 studies (typically involves 1,000 to 5,000 people with the ailment that the new drug is intended to treat). The pre-NDA period, just before a new drug application (NDA) is submitted. A common time for the FDA and drug sponsors to meet. Submission of an NDA is the formal step asking the FDA to consider a drug for marketing approval. After an NDA is received, the FDA has 60 days to decide whether to file it so it can be reviewed. If the FDA files the NDA, an FDA review team is assigned to evaluate the sponsors research on the drugs safety and effectiveness. This review may take from 6 months to 2 years. The FDA reviews information that goes on a drugs professional labeling (information on how to use the drug). The FDA inspects the facilities where the drug will be manufactured as part of the approval process. FDA reviewers will approve the application or find it either approvable or not approvable. Post marketing study commitments, also called Phase 4 commitments. Comprehensive Drug Abuse Prevention and Control Act of 1970 (with updates) The Controlled Substances Act (CSA) was passed by Congress as Title II of the Comprehensive Drug Abuse Prevention and Control Act of 1970. And signed into law by President Richard Nixon on October 27, 1970. Since the passage of the Harrison Narcotics Tax Act in 1914 many attempts had been made to strengthen government control and regulation of illicit substances with varying degrees of success. The Comprehensive Drug Abuse Prevention and Control Act is our countries most ambitious attempt to date and replaces similar legislation from the past including the Harrison Narcotics Tax Act. The Comprehensive Drug Abuse Prevention and Control Act provides for the classification, acquisition, distribution, registrationverification of prescribers, and appropriate record keeping requirements of controlled substances. This act also provided the legal framework for the creation of the Drug Enforcement Administration (DEA), which is the organization primarily tasked with the enforcement responsibilities of the CSA. To ensure an appropriate understanding of this law various updates will be included with discussion of this act. Classification of controlled substances Besides over the counter medications (OTC) such as aspirin and ibuprofen, behind the counter medications (BTC) such as Allegra-D (fexofenadine with pseudoephedrine), and prescription medications (Rx legend) such as amoxicillin and digoxin, there is another group of medications to be concerned with called controlled substances. Controlled substances are medications with further restrictions due to abuse potential. There are 5 schedules of controlled substances with various prescribing guidelines based on abuse potential counter balanced by potential medicinal benefit as determined by the Drug Enforcement Administration and individual state legislative branches. The DEA is provided with this authority by the Controlled Substances Act. Below is a brief explanation of the schedules along with example medications. Characteristics: Unaccepted medical use. Highest potential for abuse. Not available by a prescription. Examples: LSD heroin Quaaludes (methaqualone) Characteristics: High potential for abuse or misuse. Sufficient medicinal use to justify availability as a prescription. Examples: oxycodone morphine amphetamines Vicodin (hydrocodone bitartrate and acetaminophen) Characteristics: Potential risk for abuse, misuse, and dependence. Examples: Suboxone (buprenorphine and naloxone) AndroGel (testosterone) Codeine when combined with acetaminophen or a cough suppressant in a solid dosage form (tablet, capsule, etc.). Characteristics: Low potential for abuse and limited risk of dependence. Examples: phenobarbital benzodiazepines other sedatives and hypnotics Characteristics: Low potential for abuse or misuse. Examples: Cough medicines that contain a limited amount of codeine. Antidiarrheal medications that contain a limited amount of an opiate such as Lomotil (diphenoxylate and atropine). Many problems associated with drug abuse are the result of legitimately-manufactured controlled substances being diverted from their lawful purpose into the illicit drug traffic. Many of the narcotics, depressants and stimulants manufactured for legitimate medical use are subject to abuse, and have therefore been brought under legal control. The goal of controls is to ensure that these controlled substances are readily available for medical use, while preventing their distribution for illicit sale and abuse. Purchasing Controlled substances require special consideration when it comes to purchasing. Schedule III V drugs may be ordered by a pharmacy or other appropriate dispensary on a general order from a wholesaler and you should check the delivery in against the original order. The DEA 222 triplicate order form is one of two options used for the purchase of schedule II medication Schedule II drugs have much more stringent requirements. A pharmacy must register with the Drug Enforcement Administration (DEA) to purchase Schedule II medications. The purchase of such controlled substances must be authorized by a pharmacist and executed on either a triplicate DEA 222 order form or an electronic 222 form through a controlled substances ordering system (CSOS) The DEA form 222 is a triplicate form. The pharmacy retains the third sheet while sending the first and second pages to the wholesaler. The wholesaler is responsible for sending the second page to the DEA while retaining the first page for its own records. When the Schedule II medications arrive in the pharmacy they should be checked in against the DEA form. Below is an image explaining how ordering schedule II medications work with a controlled substances ordering system (CSOS) An individual enrolls with the DEA and, once approved, is issued a personal CSOS Certificate. The purchaser creates an electronic 222 order using an approved ordering software. The order is digitally signed using the purchasers personal CSOS Certificate and then transmitted to the suppliers. The paper 222 is not required for electronic ordering. The supplier receives the purchase order and verifies that the purchasers certificate is valid with the DEA. Additionally, the supplier validates the electronic order information just like it would a paper order. The supplier completes the order and ships to the purchaser. Any communications regarding the order are sent electronically. The order is reported by the supplier to the DEA within two business days. When the pharmacy receives controlled substances they should be carefully checked in against the purchase order including product name, quantity, strength, and package size. Controlled substances are shipped in separate containers from the rest of the pharmacy order and should be checked in by a pharmacist, although pharmacy technicians may assist with this process under the direct supervision of a pharmacist. Schedule II medications need to be checked in against your DEA 222 form (whether the paper triplicate form, or the electronic form on your CSOS enabled software). Schedule II medications may be stocked separately in a secure place or disbursed throughout the stock. Their stock must be continually monitored and documented. You may store CIII CV medications in one of two ways: In a secured vault or, Dispersed throughout the pharmacy stock. By dispersing the stock through out, you effectively prevent someone from being able to obtain all your controlled substances since they can not do easy One stop shopping. Controlled substances prescriptions Controlled substances have some additional things to keep in mind when reviewing prescription orders. All controlled substance prescriptions require the prescriber to include their DEA number on the prescription. While traditional prescriptions are good for one year from the date they are written and (at the prescribers discretion) may have a sufficient number of refills to cover an entire one year supply controlled substances have some differences based on which schedule they are. Schedule V medications may be refilled for up to a one year supply like prescriptions for non-controlled substances. Schedule III-IV medications may be written for up to a six month supply of medications including any refills on the original prescription. Schedule II medications may be written for up to a 90 day supply but may not include any refills. If a patient has a 30 day limit from their insurance the physician would need to write three separate prescriptions for thirty days to cover the full 90 days. Prescribers are not allowed to exceed a 90 day supply of a schedule II medications with out seeing the patient again. Telephone orders and facsimiles Pharmacies may accept telephone orders and faxes for schedule III-V medications. The pharmacist must immediatley reduce telephone order prescriptions to writing. Schedule II medications may not be ordered over the phone or via a fax machine under ordinary circumstances. DEA has granted three exceptions to the facsimile prescription requirements for Schedule II controlled substances. The facsimile of a Schedule II prescription may serve as the original prescription as follows: A practitioner prescribing Schedule II narcotic controlled substances to be compounded for the direct administration to a patient by parenteral, intravenous, intramuscular, subcutaneous or intraspinal infusion may transmit the prescription by facsimile. The pharmacy will consider the facsimile prescription a written prescription andno further prescription verification is required.All normal requirements of a legal prescription must be followed. Practitioners prescribing Schedule II controlled substances for residents of Long Term Care Facilities (LTCF) may transmit a prescription by facsimile to the dispensing pharmacy. The practitioners agent may also transmit the prescription to the pharmacy. The facsimile prescription serves as the original written prescription for the pharmacy. A practitioner prescribing a Schedule II narcotic controlled substance for a patient enrolled in a hospice care program certified andor paid for by Medicare under Title XVIII or a hospice program which is licensed by the state may transmit a prescription to the dispensing pharmacy by facsimile. The practitioner or the practitioners agent may transmit the prescription to the pharmacy. The practitioner or agent will note on the prescription that it is for a hospice patient. The facsimile serves as the original written prescription. For Schedule II controlled substances, an oral order is only permitted in an emergency situation. An emergency situation is defined as a situation in which: Immediate administration of the controlled substance is necessary for the proper treatment of the patient. No appropriate alternative treatment is available. Provision of a written prescription to the pharmacist prior to dispensing is not reasonably possible for the prescribing physician. In an emergency, a practitioner may call-in a prescription for a Schedule II controlled substance by telephone to the pharmacy, and the pharmacist may dispense the prescription provided that the quantity prescribed and dispensed is limited to the amount adequate to treat the patient during the emergency period. The prescribing practitioner must provide a written and signed prescription to the pharmacist within seven days. Further, the pharmacist must notify DEA if the prescription is not received. E-prescribing The regulations concerning electronic transmission of controlled substances via e-prescribing recently changed. As of June 1, 2010 physicians and pharmacies are now allowed to transmit prescriptions for Schedule II, III, IV, and V medications as long as they are using properly certified software (i.e. SureScripts). While this is a recent shift in federal law, some states may still prohibit e-prescribing for controlled substances. Partial fill of prescriptions Pharmacists often question the DEA rule regarding the partial refilling of Schedule III, IV, or V prescriptions. Confusion lies in whether or not a partial fill or refill is considered one fill or refill, or if the prescription can be dispensed any number of times until the total quantity prescribed is met or 6 months has passed. According to the DEAs interpretation, as long as the total quantity dispensed meets with the total quantity prescribed with the refills, and they are dispensed within the 6-month period, the number of refills is irrelevant. The Code of Federal Regulations states that the partial filling of a prescription for a controlled substance listed in Schedule III, IV, or V is permissible, provided that: Each partial filling is recorded in the same manner as a refilling. The total quantity dispensed in all partial fillings does not exceed the total quantity prescribed. No dispensing occurs 6 months after the date on which the prescription was issued for schedule III and IV medications or 12 months after the date on which the prescription was issued for schedule V medications. For a Schedule II drug, the pharmacist may partially dispense a prescription if he or she is unable to supply the full quantity in a written or emergency oral prescription, provided the pharmacist notes the quantity supplied on the front of the prescription. The remaining portion must be supplied within 72 hours of the first partial dispensing. Otherwise, the pharmacist is obligated to notify the prescribing physician of the shortage. Transferring prescriptions The DEA allows the transfer of original prescription information for Schedule III, IV, and V controlled substances for the purpose of refill dispensing between pharmacies on a one-time basis. Pharmacies which electronically share a real-time, online database may transfer up to the maximum number of refills permitted by the law and authorized by the prescriber. In either type of transfer, specific information must be recorded by both the transferring and the receiving pharmacist. The DEA does not allow for the transfer of Schedule II controlled substances, as they do not allow refills on these medications and partial fills, as discussed above, have strict limitations. DEA number verification Many problems associated with drug abuse are the result of legitimately-manufactured controlled substances being diverted from their lawful purpose into the illicit drug traffic. Many of the narcotics, depressants and stimulants manufactured for legitimate medical use are subject to abuse, and have therefore been brought under legal control. The goal of controls is to ensure that these controlled substances are readily available for medical use, while preventing their distribution for illicit sale and abuse. Under federal law, all businesses which manufacture or distribute controlled drugs, all health professionals entitled to dispense, administer or prescribe them, and all pharmacies entitled to fill prescriptions must register with the DEA. Authorized registrants receive a DEA number. Registrants must comply with a series of regulatory requirements relating to drug security, records accountability, and adherence to standards. A DEA number is a series of numbers assigned to a health care provider (such as a dentist, physician, nurse practitioner, or physician assistant) allowing them to write prescriptions for controlled substances. Legally the DEA number is solely to be used for tracking controlled substances. The DEA number, however, is often used by the industry as a general prescriber number that is a unique identifier for anyone who can prescribe medication. This is a short video demonstrating how to validate a physicians DEA number. A valid DEA number consists of: 2 letters and 7 digits The first letter is always an A (deprecated), B (most common), or F (new) for a dispenser. (Also M is available for mid-level practitioners in some states and either P or R is used for a wholesaler) The second letter is typically the initial of the registrants last name The seventh digit is a checksum that is calculated as: Add together the first, third and fifth digits Add together the second, fourth and sixth digits and multiply the sum by 2 Add the above 2 numbers The last digit (the ones value) of this last sum is used as the seventh digit in the DEA number Record keeping requirements Every pharmacy must maintain complete and accurate records on a current basis for each controlled substance purchased, received, distributed, dispensed, or otherwise disposed of. These records must be maintained for 2 years. It is also required that records and inventories of Schedule II and Schedule III, IV, and V drugs must be maintained separately from all other records or be in a form that is readily retrievable from other records. The readily retrievable requirement means that records kept by automatic data processing systems or other electronic means must be capable of being separated out from all other records in a reasonable time. In addition, some notation, such as a C stamp, an asterisk, red line, or other visually identifiable mark must distinguish controlled substances from other items. Inventory requirements A pharmacy is required by the DEA to take an inventory of controlled substances every 2 years (biennially). This inventory must be done on any date that is within 2 years of the previous inventory date. The inventory record must be maintained at the registered location in a readily retrievable manner for at least 2 years for copying and inspection by the Drug Enforcement Administration. An inventory record of all Schedule II controlled substances must be kept separate from those of other controlled substances. Submission of a copy of any inventory record to the DEA is not required unless requested. When taking the inventory of Schedule II controlled substances, an actual physical count must be made. For the inventory of Schedule III, IV, and V controlled substances, an estimate count may be made. If the commercial container holds more than 1000 dosage units and has been opened, however, an actual physical count must be made. Theft or loss of controlled substances In the event that controlled substances are stolen, or are found to be missing a pharmacy should: contact the local police and the DEA, fill out and file DEA form 106. The DEA form 106 is available as both a printed form, or may be filed electronically. To obtain the printed form click here and printout the PDF. To file elctronically proceed to deadiversion.usdoj.govwebformsdtlLogin.jsp. The DEA requires that theft of controlled substances must be reported within 24 hours. State regulations Many states have additional regulations for controlled substances. It is a necessary to know the differences that exist in your state. Some examples include: Some states have made additional drugs scheduled medications such as Arkansas and Kentucky have made tramadol a controlled substance. Many states, such as Pennsylvania, treat schedule V prescriptions the same as schedule III and IV prescriptions with regards to refill limits and totally quantity that may be prescribed at a time. Various states, such as New York, limit schedule II prescriptions to a 30 day supply. Some states, such as Hawaii and Montanna, currently do not allow e-prescribing of controlled substances. Be aware of the differences with regards to controlled substances in the states you practice in and remember that the expectation when state and federal law appear to be in conflict is that you will follow the stricter regulation. Occupational Safety and Health Act of 1970 The Occupational Safety and Health Act of 1970 was signed into law on December 29, 1970 by President Richard M. Nixon, and it created both the Occupational Safety and Health Administration (OSHA)and the National Institute for Occupational Safety and Health (NIOSH). This act is intended to prevent work-related injuries, illnesses and deaths by issuing and enforcing rules (called standards) for workplace safety and health. Since its inception, workplace fatalities have been cut by 77 and workplace injuries have declined 55 while employment has doubled from 56 million workers at 3.5 million work-sites to 115 million workers at nearly 7 million work-sites The portions that most strongly impact pharmacy are: Written hazard communication program Material Safety Data Sheets (MSDS) Air contaminants Flammable and combustible liquids General concerns about hazardous materials The act provides stern enforcement policies with fines up to 10,000 for instances where employers willfully expose workers to serious harm or death. Any act of criminal negligence can result in imprisonment of up to six months. Poison Prevention Packaging Act of 1970 The Poison Prevention Packaging Act (PPPA) of 1970 was signed into law on December 30, 1970 by President Richard M. Nixon. Before the PPPA was enacted poisonings by common household substances, including medicines, had long been considered by pediatricians to be the leading cause of injuries among children under 5 years of age. After the PPPA and the implementation of standards to prevent poisonings, the Consumer Product Safety Commission (CPSC) reported that child-resistant packaging reduced the oral prescription medicine-related death rate by up to 1.4 deaths per million children under age 5 years. This represented a reduction in the rate of fatalities of up to 45 from levels that would have been projected in the absence of child-resistant packaging requirements, and equated to about 24 fewer child deaths annually. The purpose of the PPPA was to give to the CPSC authority to require special packaging of household products and drugs to protect children from serious injury or illness. Manufacturers are required to perform tests to ensure that children under 5 years of age would find the packaging significantly difficult to open. In these tests, pairs of children aged 42 to 51 months are selected and given 5 minutes in which to open the packages. If the children cannot open the package, they are then given a visual demonstration and another 5 minutes in which to open the package. The package is considered to be child-resistant if not more than 20 of the 200 children tested can open the package. Adults are also tested with the same packages. Adults are likewise given a 5-minute period to open and properly close the package. If 90 of the 100 adults tested can open and close the child-resistant package, it passes. The PPPA affects pharmacy practice and manufacturing of OTC and prescription medications in many ways. Failure to comply with packaging requirements or any of the applicable regulations is considered a misbranding violation under the FDC Act. A pharmacist could be prosecuted and imprisoned for not more than 1 year or sentenced to pay a fine of not more than 1000, or both. All legend drugs and controlled dangerous substances must be packaged in a child-resistant container, with limited exceptions. Pharmacists should be familiar with their responsibilities under the PPPA. OTC products also require child-resistant packaging, with one exception. Manufacturers may market one size of an OTC product for the elderly or handicapped in noncompliant containers, provided that the package states, This Package for Households Without Young Children. Exceptions to child-resistant packaging for prescription drugs Patient requests non-child-resistant packaging. Physician requests non-child-resistant packaging. Sublingual dosage forms of nitroglycerin. Sublingual and chewable forms of isosorbide dinitrate in dosage strengths of 10 mg or less. Erythromycin ethylsuccinate granules for oral suspension and oral suspensions in packages containing not more than 8 grams of the equivalent of erythromycin. Cyclically administered oral contraceptives in manufacturers mnemonic (memory-aid) dispenser packages that rely solely upon the activity of one or more progestogen or estrogen substances. Anhydrous cholestyramine in powder form. All unit dose forms of potassium supplements, including individually-wrapped effervescent tablets, unit dose vials of liquid potassium, and powdered potassium in unit-dose packets, containing not more than 50 milliequivalents of potassium per unit dose. Sodium fluoride drug preparations including liquid and tablet forms, containing not more than 110 milligrams of sodium fluoride (the equivalent of 50 mg of elemental fluoride) per package or not more than a concentration of 0.5 percent elemental fluoride. Betamethasone tablets packaged in manufacturers dispenser packages, containing no more than 12.6 milligrams betamethasone. Pancrelipase preparations in tablet, capsule, or powder form. Prednisone in tablet form, when dispensed in packages containing no more than 105 mg. Mebendazole in tablet form in packages containing not more than 600 mg. Methylprednisolone in tablet form in packages containing not more than 84 mg. Colestipol in powder form in packages containing not more than 5 grams of the drug. Erythromycin ethylsuccinate tablets in packages containing no more than the equivalent of 16 grams erythromycin. Conjugated Estrogens Tablets, U.S.P. when dispensed in mnemonic packages containing not more than 32.0 mg of the drug. Norethindrone Acetate Tablets, U.S.P. when dispensed in mnemonic packages containing not more than 50 mg of the drug. Medroxyprogesterone acetate tablets. Sacrosidase (sucrase) preparations in a solution of glycerol and water. Hormone Replacement Therapy Products that rely solely upon the activity of one or more progestogen or estrogen substances. Products intended for topical application. Products in dosage forms not intended for oral administration. Pharmacist guidelines and responsibilities under the PPPA The pharmacist is responsible for ensuring packaging of required drugs in child-resistant containers. Prescription drugs provided by the manufacturer in child-resistant containers may be dispensed directly to the patient in that container. In general, plastic vials, which have previously been dispensed to the patient, cannot be reused for refills. Institutionalized patients are not required to receive child-resistant containers, but drugs for home use must comply with the PPPA. The CPSC recommends that pharmacists obtain a written authorization from patients for conventional packaging, although such is not a requirement. Medical Device Amendments of 1976 President Gerald Ford signing a bill into law. The Medical Device Amendments of 1976 were signed by President Gerald R. Ford on May 28, 1976. This is an amendment to the Food, Drug, and Cosmetic Act of 1938. While the Cooper Committee recommendations were being debated in Congress during 1972 and 1973, pacemaker failures were reported. And in 1975, hearings took place on problems that had been reported with the Dalkon Shield intrauterine device, which caused thousands of reported injuries. Those two incidents helped underscore the need for the Medical Device Amendments, enacted in 1976. President Ford, in signing the law, said, The Medical Device Amendments of 1976 eliminate the deficiencies that accorded FDA horse and buggy authority to deal with laser age problems. He added, I welcome this legislation and commend the FDA, who identified the need, cooperated in its development, and finally, will be entrusted with its enforcement. The infamous Dalkon Shield The 1976 amendments defined devices similarly to drugs, but noted that drugs cause a chemical reaction in the body, whereas devices do not. They called for all devices to be divided into classes, with varying amounts of control required in each one. Tongue depressors, for example, would fall under general controls of the types already existing (Class I) wheelchairs would be subjected to performance standards when general controls were deemed insufficient to assure product safety and effectiveness (Class II) while artificial hearts would be required to go through pre-market approval (Class III). The agencys first device performance standard was developed for impact-resistant lenses in eyeglasses and sunglasses. The final provisions of the 1976 amendments closely resemble the Cooper Committee recommendations. In addition to the medical device inventory and classification requirements, Class III device manufacturers were required to notify the FDA prior to marketing. New devices that were substantially equivalent to pre-1976 devices could be marketed immediately, subject to any existing or future requirements for that type of device. Good Manufacturing Practice (GMP) regulations also were authorized at that time. These are a set of procedures to ensure that devices are manufactured to be safe and effective through quality design, manufacture, labeling, testing, storage, and distribution. Federal Antitampering Act of 1983 In the early morning of Wednesday, September 29, 1982, 12-year-old Mary Kellerman of Elk Grove Village died after taking a capsule of Extra Strength Tylenol. Adam Janus of Arlington Heights died in the hospital shortly thereafter. His brother, Stanley (of Lisle), and his wife Theresa died after gathering to mourn, taking pills from the same bottle. By October 1, 1982, the poisoning had also taken the lives of Paula Prince of Chicago, Mary Reiner of Winfield, and Mary McFarland of Elmhurst. Investigators soon discovered the Tylenol link. Urgent warnings were broadcast, and police drove through Chicago neighborhoods issuing warnings over loudspeakers. As the tampered bottles came from different factories, and the seven deaths had all occurred in the Chicago area, the possibility of sabotage during production was ruled out. Instead, the culprit was believed to have entered various supermarkets and drug stores over a period of weeks, pilfered packages of Tylenol from the shelves, adulterated their contents with solid cyanide compound at another location, and then replaced the bottles. In addition to the five bottles which led to the victims deaths, three other tampered bottles were discovered. Johnson amp Johnson, the parent company of McNeil, distributed warnings to hospitals and distributors and halted Tylenol production and advertising. On October 5, 1982, it issued a nationwide recall of Tylenol products an estimated 31 million bottles were in circulation, with a retail value of over 100 million. The company also advertised in the national media for individuals not to consume any products that contained Tylenol. When it was determined that only capsules were tampered with, they offered to exchange all Tylenol capsules already purchased by the public with solid tablets. The perpetrator has never been caught, but the incident led to reforms in the packaging of over-the-counter substances and to federal anti-tampering laws. Orphan Drug Act of 1983 Thirty-four years ago (in 1980), Abbey Meyers was at her wits end. Her young son, who had Tourettes syndrome, had been cut off from the drug pimozide, which had begun to show promise in treating his debilitating condition. The doctor running the clinical trial told her the study was halted when McNeil Laboratories pulled out of producing the drug because it proved ineffective against schizophrenia, its primary (and more common) target. He told Meyers that pimozide would now be considered an orphan drug, the term for products that target too few patients to bring in big bucks. Now, her sons rare disorder was essentially untreatable. There was no recourse for the Connecticut housewife. I was devastated, she says. Drug research needed to be done on this disease, but the number of patients with Tourettes syndrome were so few that research was very cost prohibitive. With this and concerns over other rare diseases the Orphan Drug Act was enacted on January of 1983 An orphan drug is any drug developed under the Orphan Drug Act of January 1983 (ODA), a federal law concerning rare diseases (orphan diseases), defined as diseases affecting fewer than 200,000 people in the United States or low prevalence is taken as prevalence of less than 5 per 10,000 in the community. Because medical research and development of drugs to treat such diseases is financially disadvantageous, companies that do so are rewarded with tax reductions and marketing exclusivity, or a monopoly, on that drug for an extended time (seven years post-approval). The concept behind the ODA is that the longer period of exclusivity will encourage more companies to invest money in research. Under the act many drugs have been developed, including drugs to treat glioma, multiple myeloma, cystic fibrosis, and snake venom. In the US, from January 1983 to October 2008, a total of 1,800 different orphan drug designations have been granted by the Office of Orphan Products Development (OOPD) and 325 orphan drugs have received marketing authorization in the US. In contrast, the decade prior to 1983 saw fewer than ten such products come to market. Since few markets would naturally exist to create these goods, as the costs of developing, researching and producing these drugs would likely exceed any revenues, government intervention is required, usually to establish such a market or to produce the goods itself. Critics of the free market often cite this as a market failure in free market economic systems. Free market advocates often respond that without government intervention development costs would be considerably lower. The intervention by government can take a variety of forms: Tax benefits to companies who produce or research these drugs. Granting of additional rights above and beyond those granted by the regular patent laws. Subsidizing and funding clinical research by universities and industry sponsors to develop medical products (including drugs, biological products, devices, and medical foods) for rare diseases. Creating a government-run company to research and produce drugs. Drug Price Competition and Patent-Term Restoration Act of 1984 Above is a graph demonstrating the consistent growth in the percentage of prescriptions filled with generic medications since the passage of the Hatch-Waxman Act in 1984. The Drug Price Competition and Patent Term Restoration Act, informally known as the Hatch-Waxman Act, established the modern system of generic drugs. According to the Congressional Budget Office, generic drugs save consumers an estimated 10 billion per year at retail pharmacies alone. The informal name comes from the Acts two sponsors, representative Henry Waxman (D) of California and senator Orrin Hatch (R) of Utah. Hatch-Waxman amended the Federal Food, Drug, and Cosmetic Act. It sets forth the process by which would-be marketers of generic drugs can file Abbreviated New Drug Applications (ANDAs) to seek FDA approval of the generic. It allows 180 day exclusivity to companies that are the first-to-file an ANDA against holders of patents for branded counterparts. The FDA will consider a generic product equivalent to a brand drug when both the rate and extent of absorption are not significantly different when administered in the same dose of therapeutic ingredient under similar experimental conditions in studies. The FDA has established specific statistical standards to make a determination of bioequivalence. The Hatch-Waxman Act grants generic manufacturers standing to mount a validity challenge without incurring the cost of entry or risking enormous damages flowing from any possible infringement. Hatch-Waxman essentially redistributes the relative risk assessments and explains the flow of settlement funds and their magnitude. Hatch-Waxman gives generics considerable leverage in patent litigation: the exposure to liability amounts to litigation costs, but pales in comparison to the immense volume of generic sales and profits. The other significant factor affecting the pharmaceutical industry was an increase in the length of time for a drug patent to expire from 12 years to 17 years (since then the URAA has extended it to 20 years). This extension was intended to off-set the time it took for a drug to be approved to provide adequate time for the original innovator companies to recoup their initial research investments and make a profit. Prescription Drug Marketing Act of 1987 The Prescription Drug Marketing Act (PDMA), which was incorporated into the FDCA, was enacted to address certain prescription drugmarketing practices that have contributed to the diversion of large quantities of such drugs into a secondary gray market. These marketing practicesincluding the distribution of free samples and the sale of deeply discounted drugs to hospitals and health care entitieshave helped fuel a multi million dollar drug diversion market that provides a portal through which mislabeled, subpotent, adulterated, expired, and counterfeit drugs are able to enter the nations drug distribution system. The most simple and straightforward of the acts which severely impacts pharmacy and is prohibited by the PDMA is the act or offer of knowingly selling, purchasing, or trading a prescription drug sample. This offense is punishable by a fine of up to 250,000 and up to 10 years imprisonment. What many pharmacists do not realize is that there is a finders fee of up to 125,000 for individuals who provide information leading to the conviction of a violator of this portion of the PDMA. Another important portion of this extensive law that affects pharmacists prohibits the resale of any prescription drug that was previously purchased by a hospital or other health care entity. This provision was intended to eliminate a major source of drugs in the diversion market-namely, drugs that were originally purchased by hospitals or health care entities at substantially discounted prices, as allowed by the Nonprofit Institutions Act of 1938, and then resold to the retail class of trade. Congress believed that the resale of such drugs constituted an unfair form of competition. Unfortunately, due to the host of exemptions found in the PDMA and the complexity and potential loopholes, prosecution of institutional diversion cases has been rare. Omnibus Budget Reconciliation Act of 1987 On December 22, 1987, President Ronald Reagan signed the Omnibus Budget Reconciliation Act of 1987 (OBRA-87) also known as the Federal Nursing Home Reform Act. This was enacted to protect the rights of patients in long-term care facilities such as nursing homes, skilled nursing facilities, and assisted living homes. This act gave the Centers of Medicare and Medicaid Services(CMS) the authority to enact key measures to reduce unnecessary costs while improving the quality of patient care in these facilities. Prior to the passage of this act there were many patient treatment practices that are considered unethical by todays standards including routine orders for all patients to receive antidepressants without diagnosis of an appropriate condition, lack of routine monitoring of medication therapy, and frequent use of patient restraints (physical and chemical) at medically unnecessary times. Some of the most important resident provisions in OBRA-87 include: Emphasis on a residents quality of life as well as the quality of care New expectations that each residents ability to walk, bathe, and perform other activities of daily living will be maintained or improved absent medical reasons A resident assessment process leading to development of an individualized care plan 75 hours of training and testing of paraprofessional staff Rights to remain in the nursing home absent non-payment, dangerous resident behaviors, or significant changes in a residents medical condition New opportunities for potential and current residents with mental retardation or mental illnesses for services inside and outside a nursing home A right to safely maintain or bank personal funds with the nursing home Rights to return to the nursing home after a hospital stay or an overnight visit with family and friends The right to choose a personal physician and to access medical records The right to organize a nd participate in a resident or family council The right to be free of unnecessary and inappropriate physical and chemical restraints Uniform certification standards for Medicare and Medicaid homes Prohibitions on turning to family members to pay for Medicare and Medicaid services and New remedies to be applied to certified nursing homes that fail to meet minimum federal standards. Anabolic Steroids Control Act of 1990 Anabolic steroids are defined as synthetic derivatives of the male hormone testosterone, having pronounced anabolic properties and relatively weak andronergic properties (i.e. producing masculine characteristics), which are used clinically mainly to promote growth and to repair body tissue in senility, debilitating illness, and convalescence. Anabolic steroids may also be referred to as andronergic-anabolic steroids. The intent of the ASCA is to minimize (or eliminate) the use of anabolic steroids for non-medical purposes. Prior to the ASCA, anabolic steroids were regulated as drugs pursuant to the FDCA. The DEA has classified anabolic steroids as Schedule III controlled substances however, certain products which are considered to have no significant potential for abuse because of their concentration, preparation, mixture, or delivery system, are exempt from being classified as control substances (such as Premarin with methyltestosterone tablets). In addition, the classification does not include anabolic steroids expressly intended for cattle or other non-human species and which are approved by the FDA. However, prescribing, dispensing or distributing such substances for other than implantation in cattle or other non-human species is a violation of the law. Omnibus Budget Reconciliation Act of 1990 While most federal laws provide the pharmacist with guidance on handling pharmaceuticals, the Omnibus Budget Reconciliation Act of 1990 (OBRA-90) placed expectations on the pharmacist in how to interact with the patient. While the primary goal of OBRA-90 was to save the federal government money by improving therapeutic outcomes, the method to achieve these savings was implemented by imposing on the pharmacist counseling obligations, prospective drug utilization review (ProDUR) requirements, and record-keeping mandates. The OBRA-90 ProDUR language requires state Medicaid provider pharmacists to review Medicaid recipients entire drug profile before filling their prescription(s). The ProDUR is intended to detect potential drug therapy problems. Computer programs can be used to assist the pharmacist in identifying potential problems. It is up to the pharmacists professional judgment, however, as to what action to take, which could include contacting the prescriber. As part of the ProDUR, the following are areas for drug therapy problems that the pharmacist must screen: Therapeutic duplication Drugdisease contraindications Drugdrug interactions Incorrect drug dosage Incorrect duration of treatment Drugallergy interactions Clinical abusemisuse of medication OBRA-90 also required states to establish standards governing patient counseling. In particular, pharmacists must offer to discuss the unique drug therapy regimen of each Medicaid recipient when filling prescriptions for them. Such discussions must include matters that are significant in the professional judgment of the pharmacist. The information that a pharmacist may discuss with a patient is found in the enumerated list below. Name and description of the medication. Dosage form, dosage, route of administration, and duration of drug therapy. Special directions and precautions for preparation, administration, and use by the patient. Common severe side effects or adverse effects or interactions and therapeutic contraindications that may be encountered. Techniques for self-monitoring of drug therapy. Proper storage. Refill information. Action to be taken in the event of a missed dose. Under OBRA-90, Medicaid pharmacy providers also must make reasonable efforts to obtain, record, and maintain certain information on Medicaid patients. This information, including pharmacist comments relevant to patient therapy, would be considered reasonable if an impartial observer could review the documentation and understand what has occurred in the past, including what the pharmacist told the patient, information discovered about the patient, and what the pharmacist thought of the patients drug therapy. Information that would be included in documented information are listed below. Name, address, and telephone number. Age and gender. Disease state(s) (if significant) Known allergies andor drug reactions. Comprehensive list of medications and relevant devices. Pharmacists comments about the individuals drug therapy. While OBRA-90 was geared to ensure that Medicaid patients receive specific pharmaceutical care, the overall result of the legislation provided that the same type of care be rendered to all patients, not just Medicaid patients. The individual states did not establish 2 standards of pharmaceutical care-one for Medicaid patients and another for non-Medicaid patients. The end result is that all patients are under the same professional care umbrella requiring ProDUR, counseling, and documentation. Dietary Supplement Health and Education Act of 1994 A dietary supplement is defined under the Dietary Supplement Health and Education Act of 1994 (DSHEA) as a product that is intended to supplement the diet and bears or contains one or more of the following dietary ingredients: a vitamin a mineral an herb or other botanical (excluding tobacco) an amino acid a dietary substance for use by man to supplement the diet by increasing the total dietary intake, or a concentrate, metabolite, constituent, extract, or combination of any of the above Furthermore, it must be: intended for ingestion in pill, capsule, tablet, powder or liquid form not represented for use as a conventional food or as the sole item of a meal or diet labeled as a dietary supplement The Dietary Supplement Health and Education Act (DSHEA) was signed by President Clinton on October 25, 1994. Pursuant to the DSHEA, the Food and Drug Administration regulates dietary supplements as foods, and not as drugs. The FDA does not approve dietary supplements based on their safety and efficacy the FDA can take action only after a dietary supplement has been proven harmful. However, certain foods (such as infant formula and medical foods) are deemed special nutritionals because they are consumed by highly vulnerable populations and are thus regulated more strictly than the majority of dietary supplements. The FDA claims that their rationale for a lack of regulation is a freedom to choose by the consumer, but there are economic benefits as well. The FDA chooses not to regulate dietary supplements because clinical trials are lengthy and costly. They tend to believe that the supplement is beneficial until problems arise. Some interesting facts about dietary supplements include: It has been estimated that 40 of the US population uses dietary supplements often and that almost twice as many have used at least 1 of the estimated 29,000 dietary supplements on the market. Although most consumers of alternative therapies also take prescription medications, one survey found that 72 of respondents who used alternative therapies did not report that use to their health care providers. Despite their widespread use, health care providers often fail to ask patients about their use of these substances when asked about their current use of medications. In 1993, dietary supplement out-of-pocket expenditures were at 4.1 billion (up slightly from 1992s 3.9 billion expenditure) but after DSHEA was implemented, 1994 expenditures on dietary supplements nearly doubled to 8.1 billion. Finding reliable and unbiased information on herbal remedies continues to be a challenge, yet out-of-pocket expenditures on dietary supplements exceeded 22 billion in 2007 (accurate numbers for more recent years have not yet been made available). Uruguay Round Agreements Act of 1994 The word patent originates from the Latin patere, which means to lay open (i.e. to make available for public inspection). A patent makes an invention viewable by the public, but also ensures a limited monopoly to the creator. From when a patent is granted, till it expires no one else is allowed to make anything that requires your patent without your express permission. The Uruguay Round Agreement Act (URAA) was signed by President Clinton on December 8, 1994 which had an impact on a number of intellectual property laws. The part that impacts pharmacy the most is it extending patents to 20 years from the date of filing (prior to this it was 17 years under the Hatch-Waxman Act). Health Insurance Portability and Accountability Act of 1996 The Health Insurance Portability and Accountability Act of 1996 (HIPAA) is the most significant piece of federal legislation to affect pharmacy practice since OBRA-90. The Privacy Rule component of HIPAA took effect on April 14, 2003, and was the first comprehensive federal regulation designed to safeguard the privacy of protected health information (PHI). Pharmacies that maintain patient information in electronic format or conduct financial and administrative transactions electronically, such as billing and fund transfers, must comply with HIPAA. While HIPAA places stringent requirements on pharmacies to adopt policies and procedures relating to the protection of patient PHI, the law also gives important rights to patients. These rights include the right to access their information, the right to seek details of the disclosure of information, and the right to view the pharmacys policies and procedures regarding confidential information. The Health Insurance Portability and Accountability Act (HIPAA) imposes 5 key provisions upon pharmacies. The first provision is the requirement that each pharmacy take reasonable steps to limit the use of, disclosure of, and the requests for PHI. PHI is defined as individually identifiable health information transmitted or maintained in any form and via any medium. To be in compliance, a pharmacy must implement reasonable policies and procedures that limit how PHI is used, disclosed, and requested for certain purposes. The pharmacy also is obligated to post its entire notice of privacy practices at the facility in a clear and prominent location and on its Web site (if one exists). The second component of HIPAA requires that individuals be informed of the privacy practices of the pharmacy and that the pharmacy develop and distribute a notice with a clear explanation of these rights and practices. This notice must be given to every individual no later than the date of the first service provided, which usually means the first prescription dispensed to the patient. The pharmacist also is obligated to make a good-faith effort to obtain the patients written acknowledgment of the receipt of the notice. Under the third component, pharmacies are required, as well, to select a compliance officer who will manage and ensure compliance with HIPAA. As part of the fourth component of HIPAA, all employees working in the pharmacy environment in which PHI is maintained must receive training on the regulations within a reasonable time after being hired. This training necessarily includes pharmacists, technicians, and any other individuals who assist in the pharmacy. Finally, in some situations, it is necessary for the pharmacy to allow disclosure of PHI to a person or organization that is known under HIPAA as a business associate. Typically, business associates perform a function that requires disclosure of PHI such as billing services, claims processing, utilization review, or data analysis. Under HIPAA, a pharmacy is allowed to disclose PHI to a business associate if the pharmacy obtains satisfactory assurances, usually in the form of a contract, that the business associate will use the information only for the purposes for which it was engaged by the pharmacy. HIPAA also provides security provisions. These security provisions went into effect April 20, 2005, almost 2 years after the privacy provisions. The security standards are designed to protect the confidentiality of PHI that is threatened by the possibility of unauthorized access and interception during electronic transmission. Like the privacy provisions, any pharmacy that transmits any health information in electronic form is required to comply with the security rules. In particular, the security standards define administrative, physical, and technical safeguards that the pharmacist must consider in order to protect the confidentiality, integrity, and availability of PHI. A unique aspect of the security provisions is that they include both required and addressable implementation specifications. Required implementation specifications are those that must be met, whereas, in addressable specifications, the pharmacy must determine whether the suggested safeguards are reasonable and appropriate, given the size and capability of the organization as well as the risk. While cost may be a factor that a covered entity may consider in determining whether to implement a particular specification, nonetheless a clear requirement exists that adequate security measures be implemented. Cost considerations are not meant to exempt covered entities from this responsibility. The Health Information Technology for Economic and Clinical Health Act (HITECH Act) of 2009 provided additional privacy provisions and penalties to HIPAA when dealing with electronic protected health information (ePHI). Electronic protected health information is individually identifiable health information that is created, stored, transmitted, or received electronically. The portions that affect the HIPAA regulation on pharmacy the most are the breach reporting requirements and the financial penalties for data breaches. If a breach of ePHI occurs, the affected individuals must be notified. If the unsecured ePHI of more than 500 individuals is reasonably believed to have been, accessed, acquired, or disclosed during such a breach, the HITECH Act requires HIPAA covered entities to report this breach to Health and Human Services (HHS) and the media, in addition to notifying the affected individuals. The penalties outlined in the HITECH Act for violating the privacy provision range from 100 to 1,500,000 based on the type of disclosure, the root cause, and the number of individuals affected. Food and Drug Administration Modernization Act of 1997 The Food and Drug Administration Modernization Act (FDAMA), enacted Nov. 21, 1997, amended the Federal Food, Drug, and Cosmetic Act relating to the regulation of food, drugs, devices, and biological products. With the passage of FDAMA, Congress enhanced FDAs mission in ways that recognized the agency would be operating in a 21st century characterized by increasing technological, trade and public health complexities. FDAMA reauthorizes the Prescription Drug User Fee Act of 1992 and mandates the most wide-ranging reforms in agency practices since 1938. Provisions include measures to accelerate review of devices, regulate advertising of unapproved uses of approved drugs and devices, and regulate health claims for foods. Prescription Drug User Fee This authorizes the FDA to collect fees from companies that produce certain human drug and biological products. Any time a company wants the FDA to approve a new drug or biologic prior to marketing, it must submit an application along with a fee to support the review process. In addition, companies pay annual fees for each manufacturing establishment and for each prescription drug product marketed. Previously, taxpayers alone paid for product reviews through budgets provided by Congress. In the new program, industry provides the funding in exchange for FDA agreement to meet drug-review performance goals, which emphasize timeliness. Off-Label Medication Uses The law abolishes the long-standing prohibition on dissemination by manufacturers of information about unapproved uses of drugs and medical devices. The act allows a firm to disseminate peer-reviewed journal articles about an off-label indication of its product, provided the company commits itself to file, within a specified time frame, a supplemental application based on appropriate research to establish the safety and effectiveness of the unapproved use. Pharmacy Compounding The act creates a special exemption to ensure continued availability of compounded drug products prepared by pharmacists to provide patients with individualized therapies not available commercially. The law, however, seeks to prevent manufacturing under the guise of compounding by establishing parameters within which the practice is appropriate and lawful. FDA Initiatives and Programs The law enacts many FDA initiatives undertaken in recent years under Vice President Al Gores Reinventing Government program. The codified initiatives include measures to modernize the regulation of biological products by bringing them in harmony with the regulations for drugs and eliminating the need for establishment license application eliminate the batch certification and monograph requirements for insulin and antibiotics streamline the approval processes for drug and biological manufacturing changes and reduce the need for environmental assessment as part of a product application. The act also codifies FDAs regulations and practice to increase patient access to experimental drugs and medical devices and to accelerate review of important new medications. In addition, the law provides for an expanded database on clinical trials which will be accessible by patients. With the sponsors consent, the results of such clinical trials will be included in the database. Under a separate provision, patients will receive advance notice when a manufacturer plans to discontinue a drug on which they depend for life support or sustenance, or for a treatment of a serious or debilitating disease or condition. 2002 Best Pharmaceuticals for Children Act In January of 2002, Congress passed the Best Pharmaceuticals for Children Act (BPCA), which was its second major attempt to increase the number of clinical tests performed on pediatric populations. Congress passed the BPCA in response to the modest success of its earlier effort to promote pediatric clinical testing, the pediatric exclusivity provision of the Food and Drug Administration Modernization Act of 1997 (FDAMA). With both the 1997 and 2002 efforts, Congress has attempted to address the dearth of information about the safety and effectiveness of drugs that children commonly use. Before the passage of the FDAMA, few drugs were labeled for children, as neither Congress nor the Food and Drug Administration required pediatric testing of drugs, and drug companies rarely labeled drugs for children on their own. A 1994 study found that six of the ten drugs most commonly prescribed to children had no pediatric labeling. The BPCA does not require pediatric testing, but it does establish a two-tiered approach to ensure research of drugs used by pediatric populations. Under this approach, a manufacturer may opt to test its own drug in pediatric clinical trials and thereby earn an additional six-month term to its patent. If a manufacturer does not wish to perform such pediatric studies, the BPCA allots funds to enable the FDA to contract for the testing of those drugs for which it believes pediatric studies would be beneficial. Medicare Modernization Act of 2003 The Medicare Prescription Drug, Improvement, and Modernization Act (MMA), also called Medicare Part D, is a law that was enacted in 2003, and became effective January 1, 2006. It produced the largest overhaul of Medicare in its 38-year history. The MMA provides prescription drug coverage to patients eligible for Medicare benefits. This is a voluntary insurance program, not an automatic government benefit. This program provides some drug coverage, especially for those patients with economic hardships or those on high-cost medications. Patients are required to pay an extra premium (with their Medicare insurance) and are subject to a deductible before benefits are realized. Patients may be penalized if they elect not to join when they are healthy and are taking no or few medications. For patients on high-cost medications, a pharmacist may provide (and get reimbursed for) medication management therapy services (MMTS) or an annual in-depth review of the patients medication profile. This review is to add a safety feature to prevent adverse reactions and drug interactions and to look at ways to reduce the patient cost. Medicare coverage for the current year The numbers change annually, the following numbers are for 2016: Total Drug Spend For generic medications the enrollee pays 58. For brand name medications the enrollee pays 45. Plan pays 42 for generics, and 5 (not counted towards the gap) for brand name drugs. Additionally the wholesaler provides a 50 manufacturer discount on brand name drugs. Over 7,515 (estimated) Over 3,284 (estimated) Enrollee pays either 5 of the drug cost or 2.95generic and 7.40brand, whichever is less. In Catastrophic Coverage the plan pays 15 and Medicare pays 80. The Total Drug Spend represents the actual cost of the drugs purchased, factoring in any Medicare discounts. The TrOOP (True Out Of Pocket Costs) represents the amount of their own money that the patient has paid. The Donut Hole is shown in italics . The expenses outlined above only include the cost of prescription medications. It does not include the monthly premium that you pay to the prescription drug plan. Health Reform and Medicare Part D The Affordable Care Act signed into law on March 23, 2010 makes several changes to Medicare Part D to reduce your out-of-pocket costs when you reach the donut hole phased in over several years, including: In 2010 only, if you had expenses in the coverage gap, you should have received a 250 rebate from Medicare. Beginning in 2011, if you reach the donut hole, you will be given a 50 discount on the total cost of brand name drugs while in the gap. Beginning in 2013, if you reach the donut hole, you will be given a 52.5 discount on brand name drugs and a 21 discount on generic drugs while in the gap. Beginning in 2014, if you reach the donut hole, you will be given a 52.5 discount on brand name drugs and a 28 discount on generic drugs while in the gap. Beginning in 2016, if you reach the donut hole, you will be given a 55 discount on brand name drugs and a 42 discount on generic drugs while in the gap. Medicare will phase in additional discounts on the cost of both brand name and generic drugs. By 2020, these changes will effectively close the coverage gap and rather than paying 100 of the costs, the patients responsibility will be 25 of the costs. Example Medicare Part D patient Lets look at a faux patient named John Smith. Well say he has the early signs of Alzhiemers, high cholesterol, hypertension, fluid retention, arthritis pain, and a history of stomach ulcers (a fairly typical profile for our aging population). His PCP prescribes the following regimen of drugs: donepezil 10 mg 8.35 Crestor ( rosuvastatin ) 40 mg 276.97 digoxin 250 mcg 10.57 furosemide 20 mg 8.31 celecoxib 200 mg 92.18 Nexium ( esomeprazole ) 40 mg 229.18 This totals 625.56month. Lets do the math for his prescription drug coverage under Medicare part D if he has a plan with the typical 41.46month premium So the patient spent a total of 3,604.15 in the course of a year to receive 7,506.72 worth of medications and the patient never emerged from the Medicare Gap Combat Methamphetamine Epidemic Act of 2005 Above are some examples of products kept behind the counter at pharmacies since they contain pseudoephedrine. The Combat Methamphetamine Epidemic Act of 2005 (CMEA) was signed into United States law on March 9, 2006 to regulate, among other things, retail over-the-counter sales of ephedrine, pseudoephedrine, and phenylpropanolamine products. Retail provisions of the CMEA include daily sales limits and 30-day purchase limits, placement of product out of direct customer access, sales logbooks, customer ID verification, employee training, and self-certification of regulated sellers. The CMEA is found as Title VII of the USA PATRIOT Improvement and Reauthorization Act of 2005. Ephedrine, pseudoephedrine, and phenylpropanolamine are precursor chemicals used in the illicit manufacture of methamphetamine or amphetamine. They are also common ingredients used to make cough, cold, and allergy products. Passage of the CMEA was accomplished to curtail the clandestine production of methamphetamine. States that have enacted similar or more restrictive retail regulations have seen a dramatic drop in small clandestine labs. The Federal statute included the following requirements for merchants who sell these products: A retrievable record of all purchases identifying the name and address of each party to be kept for two years. Required verification of proof of identity of all purchasers Required protection and disclosure methods in the collection of personal information Reports to the Attorney General of any suspicious payments or disappearances of the regulated products Non-liquid dose form of regulated product may only be sold in unit dose blister packs Regulated products are to be sold behind the counter or in a locked cabinet in such a way as to restrict access Daily sales of regulated products not to exceed 3.6 grams without regard to the number of transactions A 30-day sales limit not to exceed 9 grams of pseudoephedrine base in regulated products The law gives similar regulations to mail order purchases, except the monthly sales limit is only 7.5 grams. The DEA does report a decrease in clandestine methamphetamine labs since the passage of the CMEA, but nothing is without controversy, just look at the very first arrest under this act: In September 2006, Tim Naveau was arrested and charged with a Class-B misdemeanor for purchasing Claritin D. Naveau takes one tablet of Claritin D each day to combat allergies, and his teenage son is also an allergy sufferer. Minors are not permitted to purchase pseudoephedrine under the law. Naveau had gone over the legal limit for pseudoephedrine when he purchased extra Claritin D to give to his son before he attended church camp. Medicaid Tamper-Resistant Prescription Law of 2007 Above is an example of a tamper resistant prescription pad with an explanation of its security features. The Medicaid Tamper-Resistant Prescription Pad Law was passed in late July as part of the U.S. Troop Readiness, Veterans Care, Katrina Recovery and Iraq Accountability Appropriations Act of 2007. This law requires physicians and pharmacists to use either electronic prescriptions or tamper-resistant prescription pads for their Medicaid patients. To comply, prescription pads were required to contain at least one tamper resistant feature by April 1, 2008 and since October 1, 2008 all Medicaid scripts must contain one or more industry recognized features from each of three categories of security as specified by the Center for Medicare and Medicaid Service (CMS). One or More industry-recognized features designed to prevent unauthorized copying of a completed or blank prescription form. Void Pantograph background (Hidden Message Technology) Reverse Rx Symbol Micro Printing Artificial Watermark on back of script Coin Activated Ink One or More industry-recognized features designed to prevent the erasure or modification of information written on a prescription by the prescriber. Colored Shaded Pantograph background Toner Grip Security Coating Check and Balance printed features such as quantity check boxes, and space to indicate number of medications written on prescription form One or More industry-recognized features designed to prevent the use of counterfeit prescription forms. Security Feature Warning Box and Warning Bands Security Back Printing Coin Activated Validation Batch Number identification Secure Rub Color Change Ink Consecutive Numbering Food and Drug Administration Amendments Act of 2007 On September 27, 2007, President George W. Bush signed into law the Food and Drug Administration Amendments Act of 2007 (FDAAA), further amending the Food, Drug, and Cosmetic Act. The FDAAA authorizes the Food and Drug Administration (FDA) to require risk evaluation and mitigation strategies (REMS) on medications if necessary to minimize the risks associated with some drugs. The FDA has a responsibility to ensure that the benefits of a medication outweigh the potential risks of that medication. To determine this, the FDA looks at the seriousness of the disease or condition to be treated, size of the patient population, expected benefit of the drug, expected duration of treatment, and seriousness of the known or potential adverse events. If a medications benefits outweigh the risks associated with it, the FDA approves it. Sometimes though, the medication therapy itself still carries a lot of risks with it. In that situation, the FDA may require REMS. These risk minimization strategies go beyond FDA professional labeling. FDA can require a REMS before a drug is approved if they have determined that a REMS is necessary to ensure the benefits of the drug outweigh its risks. Also, FDA can require a REMS post-approval if they become aware of new safety information and make the determination that a REMS is necessary, again, to ensure that the benefits of the drug outweigh its risks. Elements of risk evaluation and mitigation strategies REMS may contain any of the following elements: Medication Guide Document written for patients highlighting important safety information about the drug this document must be distributed by the pharmacist to every patient receiving the drug. Communication Plan Plan to educate healthcare professionals on the safe and appropriate use of the drug and consists of tools and materials that will be disseminated to the appropriate stakeholders. Elements to Assure Safe Use (EASU) These are strictly controlled systems or requirements put into place to enforce the appropriate use of a drug. Examples of EASUs include physician certification requirements in order to prescribe the drug, patient enrollment in a central registry, distribution of the drug restricted to certain specialty pharmacies, etc. Implementation Plan A description of how certain EASUs will be implemented. Timetable for Submission of Assessments The frequency of assessment of the REMS performance with regard to meeting the goal(s) and objective(s). FDA requires that assessments be conducted at 18 months, 3 years, and 7 years post-launch, at a minimum. Results of these evaluations must be reported to the FDA and will determine whether additional actions or modifications to the REMS program are required. Restricted drug programs There are a number of medications with restrictions due to patient safety concerns. The FDA primarily manages these medications through their Risk Evaluation and Mitigation Strategy (REMS) initiative. The FDA may require manufacturers of drugs with safety concerns to submit a REMS program at the time a new drug is approved. These programs may contain any combination of 5 criteria (Medication Guide, Communication Plan, Elements to Assure Safe Use, Implementation System, and Timetable for Submission of Assessments). Restricted access programs are considered Elements to Assure Safe Use. A current list of medications with REMS programs can be found at fda.govDrugsDrugSafetyPostmarketDrugSafetyInformationforPatientsandProvidersucm111350.htm. Some of the medications with the most significant restrictions include thalidomide, clozapine, buprenorphine, and isotretinoin. These programs are intended to make sure that the patients are using the medications appropriately and to monitor them for undesirable side effects. Thalidomide Thalidomide was first developed in Germany as a sleep aid and shortly after entering the European market, the manufacturer decided it was also good for treating morning sickness. Unfortunately, the drug caused severe and life-threatening birth defects in 40 of infants. In 1998 thalidomide was approved for limited distribution in the United States for treating multiple myeloma. It is also used to treat erythema nodosum leprosum. Thalidomide is only available through the THALOMID REMS program. Prescribers must be certified with program, patients must comply with the strict guidelines of the program, and pharmacies must be certified with the program. Pharmacies must only dispense to patients that are authorized to receive the drug and comply with the requirements. Clozapine is an atypical antipsychotic medication used in the treatment of schizophrenia, and is also sometimes used off-label for the treatment of bipolar disorder. Clozapine carries many warnings, including warnings for agranulocytosis, CNS depression, leukopenia, neutropenia, seizure disorder, bone marrow suppression, dementia, hypotension, myocarditis, orthostatic hypotension (with or without syncope) and seizures. With these severe side effects in mind each of the manufacturers are required to enroll patients taking their medication into a national registry where they will monitor a patients white blood cell count (WBC) and their absolute neutrophil count (ANC). If the numbers fall below a particular level their therapy may need to be halted and the national registry has a responsibility to report the information to the nonrechallengeable database, that way if a physician goes to place the patient on the medication again the various manufacturers will know they are not allowed as they always need to check new orders for a patient against the nonrechallengeable database. Once listed in the nonrechallengeable database they may never use clozapine again. Buprenorphine The Drug Addiction Treatment Act of 2000 (DATA 2000) permits physicians who meet certain qualifications to treat opioid addiction with Schedule III, IV, and V narcotic medications that have been specifically approved by the Food and Drug Administration for that indication. Such medications may be prescribed and dispensed by waived physicians in treatment settings other than the traditional Opioid Treatment Program (methadone clinic) setting. Since there is only one narcotic medication approved by the FDA for the treatment of opioid addiction within the Schedules given, DATA 2000 basically refers to the use of buprenorphine for the treatment of opioid addiction. Methadone is a Schedule II narcotic approved for the same purpose within the highly regulated methadone clinic setting. Under the Act, physicians may apply for a waiver to prescribe buprenorphine for the treatment of opioid addiction or dependence. Requirements include a current State medical license, a valid DEA registration number, specialty or subspecialty certification in addiction from the American Board of Medical Specialties, American Society of Addiction Medicine, or American Osteopathic Association. Exceptions were also created for physicians who participated in the initial studies of buprenorphine and for State certification of addiction specialists. However, the Act is intended to bring the treatment of addiction back to the primary care provider. Thus most waivers are obtained after taking an 8 hour course from one of the five medical organizations designated in the Act and otherwise approved by the Secretary of the Department of Health and Human Services. When a physician qualifies for the waiver, he is given a second DEA number that begins with an X. This new DEA number is only to be used when prescribing buprenorphine for the purpose of treating addictions. Once a physician obtains the waiver, he or she may treat up to 30 patients for narcotic addiction with buprenorphine. Recent changes to DATA 2000 have increased the patient limit to 100 for physicians that have had their waiver for a year or more and request the higher limit in writing. Isotretinoin Isotretinoin is indicated for severe nodular acne unresponsive to conventional therapy in patients 12 years of age and older. Isotretinoin is a teratogen and is highly likely to cause birth defects if taken by women during pregnancy or even a short time before conception. A few of the more common birth defects this drug can cause are hearing and visual impairment, missing or malformed earlobes, facial dysmorphism, and mental retardation. Due to the teratogenicity of this product, isotretinoin is only available through a restricted program under REMS called iPLEDGE. Prescribers, patients, pharmacies, and distributors must enroll in the iPLEDGE program (ipledgeprogram ). Patient Protection and Affordable Care Act of 2010 The Patient Protection and Affordable Care Act (PPACA) is a federal statute that was signed into United States law by President Barack Obama on March 23, 2010. This Act and the Health Care and Education Reconciliation Act of 2010 (signed into law on March 30, 2010) made up the health care reform of 2010. The laws focus on reform of the private health insurance market, provide better coverage for those with pre-existing conditions, improve prescription drug coverage in Medicare and extend the life of the Medicare Trust fund by at least 12 years, and to attempt to provide insurance covarge for the 15 of the U.S population that lacks prescription coverage. The law includes numerous health-related provisions to take effect over a four-year period beginning in 2010. In order of their assessed impact the primary provisions are as follows: Guaranteed issue and community rating will be implemented nationally so that insurers must offer the same premium to all applicants of the same age, sex, and geographical location regardless of pre-existing conditions. Medicaid eligibility is expanded to include all individuals and families with incomes up to 133 of the poverty level. Health insurance exchanges will commence operation in each state, offering a marketplace where individuals and small businesses can compare policies and premiums, and buy insurance (with a government subsidy if eligible). Firms employing 50 or more people but not offering health insurance will pay a shared responsibility payment if the government has had to subsidize an employees health care Non exempt persons not securing minimum essential health insurance coverage are also fined under the shared responsibility rules. This requirement to maintain insurance or pay a fine is often referred to as the individual mandate, though being insured is not actually mandated by law. Not being insured will not be a crime and no criminal penalty can attach to non payment of the fine. The fine serves to encourage most people into an insurance pool and to deter healthy individuals from buying insurance only when they become ill. Improved benefits for Medicare prescription drug coverage are to be implemented. Changes are enacted which allow a restructuring of Medicare reimbursement from fee-for-service to bundled payments. Establishment of a national voluntary insurance program for purchasing community living assistance services and support. Low income persons and families above the Medicaid level and up to 400 of the poverty level will receive subsidies on a sliding scale if they choose to purchase insurance via an exchange (persons at 150 of the poverty level would be subsidized such that their premium cost would be of 2 of income or 50 a month for a family of 4). Very small businesses will be able to get subsidies if they purchase insurance through an exchange. Additional support is provided for medical research and the National Institutes of Health. Enrollment into CHIP and Medicaid is simplified with improvements to both programs. The law will introduce minimum standards for health insurance policies and remove all annual and lifetime coverage caps. The law mandates that some health care insurance benefits will be essential coverage for which there will be no co-pays. Policies issued before the law came into effect are grandfathered and are mostly not affected by the new rules. Controversial portions of act Currently, this act is surrounded in a lot of controversy particularly around the issues of the individual mandate requiring all citizens to acquire health care insurance or be charged a penalty and the contraception provision requiring all health insurances to provide coverage for things such as birth control. The requirement for businesses that employ over 50 employees is also controversial, but has been pushed back till 2015. Opponents to the requirement for businesses above a specific size to provide insurance claim that this will end up being a job killer as employers may reduce the number of employees they have and not add positions in the future. To add to this, the problems with the rocky roll out of the national heath care exchange, and changing directions with the decision as to whether old health care insurance plans could be continued. The controversy over this act continues. Controversy over individual mandate On June 28, 2012, in a 5-4 ruling, the US Supreme Court ruled the individual mandate requiring people to have health insurance is valid as a tax, even though it is impermissible under the Constitutions commerce clause. In this case, however, it is reasonable to construe what Congress has done as increasing taxes on those who have a certain amount of income, but choose to go without health insurance, Chief Justice John Roberts wrote in the majority opinion. Such legislation is within Congresss power to tax. Despite the legal ruling this remains controversial as the Republican party works to find a way to repeal this legislation. Controversy over contraception As of August 2012 the womens preventative health care amendment officially went into effect. It includes eight preventive health benefits: access to free contraceptives, breast-feeding supplies, screenings for sexually transmitted infections, counseling for domestic violence and routine check-ups for breast and pelvic exams, Pap tests and prenatal care. Earlier this year, the birth control provision sparked major controversy. Religious organizations protested that they shouldnt have to comply. After weeks of backlash, the White House amended the rule to provide exemptions for religious institutions, but not private companies. Some private companies continue to express concerns over their requirement to provide such services if they have moral objections, along with concerns over the cost associated with providing contraceptives. On June 30, 2014, in a 5-4 ruling, the US Supreme Court ruled that some corporations also have religious rights to deny coverage of contraceptives. Both corporations involved in this ruling ( Conestoga Wood Specialties of Pennsylvania and the Oklahoma based arts-and-crafts retail chain Hobby Lobby ) emphasized their conscientious desire to operate in harmony with biblical principles while competing in a secular marketplace. Justice Samuel Alito wrote the majority opinion, The companies in the cases before us are closely held corporations, each owned and controlled by members of a single family, and no one has disputed the sincerity of their religious beliefs. ReferencesWhere to buy gold coins in India When you think about buying gold coins 8211 the first place that comes to your mind is probably the local jeweler, but there are a lot more options than that at your disposal, if you want to buy gold coins. In this post I am going to look at some of those options. 1. Buy gold coins at the bank . A lot of Indian banks sell gold coins these days. The benefit of buying gold coins from a reputed bank is that you have a lot more peace of mind, as far as the quality of the gold coins go. The disadvantage of buying gold from a bank is that they normally charge a premium on the gold coins, and you might be paying extra than what you would have otherwise paid at a jeweler. Another disadvantage is that normally banks don8217t buy back gold from you. If you buy gold from a reputed jeweler, then in most cases they will buy it back from you. 2. Buy gold coins at the post office: This might come as a surprise to some of you, and it certainly surprised me, but it is true that the Indian Post Office sells gold coins . They too charge a premium on the gold coins they sell, but it seems that it is less than that charged by the bank. I am not sure about this though, and it is best to check this point yourself. Like banks, the Post Office will not buy the gold back from you, and only a few post offices are allowed to sell gold coins, so this option might not even be practical for you. 3. Buy gold coins online: I saw at least a couple of websites that were selling gold coins online, and that seemed to be legitimate. I am not linking to them because I couldn8217t read any reviews on them, and do not know any one who has bought gold coins online in India. Further, when I checked the price of a 2 gram gold coin on their website and compared it with the gold coins SBI is selling, 8211 I found that the online store is charging a higher price. The online store was asking Rs. 3998 for a 2 gram 99 purity gold coin, whereas the price I saw at SBI was Rs. 3,760. This doesn8217t make much sense to me, and personally, I would rather go to a bank and buy gold coins, rather than pay extra to an online retailer to buy gold coins. 4. Buy gold coins from nation wide retailers like Tanishq: You can go to a reputed nation-wide jeweler like Tanishq, and can buy gold coins or bars from them. This offers you peace of mind because they have a strong reputation, and their good distributions means that this will be a convenient option for many of you. 5. Buy gold coins from your local jeweler: Most Indians will have a family jeweler, and if they sell gold coins or bars, then you might just find that this is the cheapest option. Furthermore, they will be willing to buy 8211 back the gold coins as well, so that is an added benefit of buying from them. These were five options that I could think of where you could buy gold coins in India, and I8217d like to hear if there are any options that you know of and I missed out on. More from my site How to find gold rate in India Can I buy gold coins at the post office Will the gold monetization scheme help me if I don8217t want to melt my gold How to buy gold coins in India It is not true that Indian Post office is selling gold coins cheaper than banks. Rather, they sell higher at about 5-6 more. The reason is not clear. Morever, their rates are not avialable on line to check by a customer. There is need to to fix limit on the maximum price a bank can charge of gold coin. At present their is difference of 5-6 in the prices. Also, the banks and post office must introduce the buy back scheme of their gold coins, as Tanisque has. This shall enhence the sale and purchase of gold coins. Govt must think to mint its own gold coin, as USA and other developed countries are doing. Yes, banks should have buy back schemes to make this investment popular You can buy the 99.99 purity gold coins, assay certified and distributed by the bank from the local jeweler and you will end up paying approximately Rs 1500 less from the actual price quoted in the bank. The computation goes as the actual market price of the 24 carat gold on that day Rs 800 1 tax if brought in Bangalore. If you are buying a 22 carat gold coin, you have to pay the actual market price of the 22 carat gold die charges which would be approximately Rs 30 per gram or some people would levy Rs 300, depends on your local jeweler. Say for example if you the bank quoted you Rs 16,500 for an 8 gm coin, you can buy that same coin from the jeweler for Rs 14,200. If you are getting an 8 g, 22 ct coin from the jeweler, you would be paying somewhere around 12,000. These figures are just approximates. Hope this helps for a better investment Thanks for the tip Alex. Is it easier to sell coins bought from a jeweler back to them as compared to coins bought in a bank Hi, Am interested to buy gold for investments and recently started exploring the market. My Findings: Banks charge a high premium for 24 Carat Gold coinsbar, but whereas my local jeweller has the same bank sealed gold coin of 24 carat on which he is charging 9 premium (as per RBI directives 9 is allowed) 1 ie 10 which i found quite reasonable compared to banks whose preiums are very high . Buyback would be at the prevailing rate of 24 carat gold on the day of sale. That means what you pay on Gold coin is the 10 premium rest is the return which you get back on the investment. Also the Gold ETF about which i have read in this site only if sold after 1 year then Long Term capital Gains LTCG would be applicable which is again 10 Hence i was trying to compare the two options in which Gold ETF seems better as for the same 10 cost you get the Gold and you dont have to pay the locker fee and storage tension . You get the benefit of investment in Gold without actual physical possession and tension of safeguarding the same. Please let me know your Views on the understanding. Hi Sowmya, these are all good observations, and let me add a few thoughts to them: 1. When you go to sell the gold coin, you might face some additional deduction as reported by people who tried selling Tanishq gold coins, so you need to keep that factor in mind while looking at physical gold. 2. Gold ETFs do have costs which are about 1 of assets for the lower ones, so this is akin to storage charges, and you can think of this money that will be reduced from your profit, or increased to your loss. 3. VAT would have to be paid on buying physical gold. So, these are some additional factors that you can evaluate. Hi Sowmya, I would like to add something to your statement below: Also the Gold ETF about which i have read in this site only if sold after 1 year then Long Term capital Gains LTCG would be applicable which is again 10 For Physical Gold, you will have to wait for 3 years (in contrast with 1 year for demat gold) in order for the gain to be taxed as Long Term Capital Gain. The Short term capital gain is added to your income in both the cases. by telling 8216wait patiently8217 iam not meaning 1 or 2 years.if you notice the share market it moves in cycles.1 0r 2 years it may be down.but after that you will get the returns more 3 times also.at 2008 market crash if you have bought gold and taken a loan and invested in equity mutual funds you would have doubled your money and the gold8217s value also increased.now you can sell the gold for high rates.and repay the loan.what ever your earned in the mutual fund is bonus. Hindsight is always 20 8211 20 8211 anyway to each his own 8211 all the best for your plan. better buy gold coins and take a loan using that from a bank.the maximum interest will be 1.5pm.invest the same in a liquid mutual fund.when ever share markets fall heavily invest part of the amount.wait patiently.once you get 3pm return with draw and pay back the loan. GB 8211 What would you do if the market really tanks, and you can8217t make the 3 per month that you are talking about This is a really risky strategy, and personally, one that doesn8217t make any sense to me at all. I have been researching gold market for three years. I will tell you this which I don8217t see any other Indian mentioning. Gold ETFs don8217t have the physical gold to back them up. ETFs are derivatives, and they are risky. If you want to participate in the gold bull market, you must buy physical gold, and never buy a piece of crap Gold ETF derivative. NSEL E-Demat is crap too. There is too much counter-party risk to these derivatives. You should buy gold for safety. Exception is if you are trading for short term. But you should not trade in gold for short term. Short term is primarily for losers or beginners. Smart people buy for the long term with the trend. There may come a time in 2,3,4, or 5 years when you may sell your gold. ONLY BUY PHYSICAL GOLD AND SILVER. That8217s not true 8211 gold ETFs are required to hold physical gold to back up their purchase which is audited as well. What8217s the basis for you saying there is no gold to back gold ETF That8217s absolutely not true. Gold ETFs are 100 backed by Physical Gold in India. I think you are speaking about the US, where there are certain funds that use the derivative way into gold. Thankfully in India though, it is not allowed. Infact, in India, even the AMCs donot have access to the gold stored in the vault. The gold is insured against any loss. It is routinely verified and audited and is taken care by the custodian of your mutual fund, which is usually a bank. The custodian keeps the gold on behalf of the investors and the amc. You are right about the gold ETFs in the U.S. using derivatives which shows that the ETFs cannot be trusted. But the same is indeed true in India. More so. Because people here are blindly trusting the custodian banks. AMCs need to have access to gold in the vault, which you yourself point is NOT the case. The custodian itself doesn8217t have gold because if they did they would release the audit results, which none of the banks have released. It shows that something is fishy with the ETFs. So, never trust them. Only buy physical gold and sivler. It8217s great information on this blog. Terima kasih. On further browsing I came across a Government run MMTC that claim to be selling Gold coins and bars however they do not have any outletsoffices in Mumbai. The only other reliable option I was able to figure out was that of National Indian Bullion Refinery. I am still to try it out. If any one has any experience with it that will help me and other readers first hand. You Could buy from MNC Bullion 99.9 purity Gold coins which are just like the Bank coins at much competitive price. I bought from them and I am happy with the coin and service. They informed me that very soon they would sell it online on their website buyorsellcoin for delivery anywhere in India As per the above post by Yash, I bought one Silver 100 grams bar from mncbullion. I must say that I am impressed with the service and the coin. The premium came about 16, which is one of the best in the Indian retail physical silver market. But today I found out about Jalan Jewellers in New Delhi. They have two branches: one in Chandni Chowk and the other in Lajpat Nagar. I went to Lajpat Nagar as their Hallmarking facility is located there. They are BIS approved for Hallmarking. You can check on this link to see their address on the table at BIS web site: Sl No. 6. bis.org.incerthallmarkass.htm The premium turned out to be slightly lower than MNC Bullion. Plus I got them to hallmark the bars. It seems MNC is not authorised to hallmark. But if you talk to them they may hallmark it through 3rd party. I am not sure. So for any one living in Delhi, I highly recommend Jalan Jewellers. Especially the Lajpat Nagar branch as the hallmarking centre is located right there. When you buy tell them you want it hallmarked. I think it is Rs. 50 per item. I once again highly recommend that you check out Jalan Jewellers. They also supply in part to MMTC and Muthoot Finance. For those who don8217t live near Delhi, they can buy from MNC Bullion, who also give great service. But again prices are slightly higher than Jalan Jewellers: about 1-2 difference. But if you can ask them to hallmark, it would be better. So, my search for buying physical silver in Delhi finally ends. First choice is Jalan Jewellers: because of price, location, hallmarking. MNC Bullion is also an alternative. Strength of MNC Bullion is that they are reputed in South India and buy amp sell online. Both of them are recognized from MCX, and NSEL. However, Jalan Jewellers is also recognized by IBMA. Great. Thanks for such a detailed information I was seeking for long. Anyone interested in buying Gold silver should go through these blogs Great information. I got a lot of good ideas to save money. I have purchased 24k gold coins of 8 grams from Manappuram jewellers. They charged me Rs.151 2 VAT additionally. Is that fair enough. How far is Karat meter reliable. i know about a company which offer8217s 24 c gold coin with 99.9 pureity in gold it muthoot finance. i think muthoot is a good option to purchase gold coin. What about the Reliance gold coin Any one has any experience with Reliance. Is it trust worthy option The main question there is whether they buy it back from the customer because that8217s when people face problems. I don8217t know if customers can sell it back to them but if they can8217t then they will face some of the same problems they face when they go to sell a bank gold coin to a jewelery shop. BTW Tanishq besides being very expensive also does not declare the premium it charges on the coin of various denomination. All the sales person has a printout of making charges etc but if told to give a copy they say it is a Policy decision. AVOID TANISHQ for me I prefer TBZ any time I have bought a gold coin at caratlanegold-coins recently. Looks like a professional site. They don8217t buy back but you can always exchange your coins with jewellery at 100 value anytime. They also have a Lowest price guarantee policy where they will re-imburse you with the difference if you are able to find a lower price in the market. Thanks Sandeep, have you already received the coin Any feedback on how long they take to deliver, and if you plan to get the purity tested or anything else like that I have received the coin. Took about 3 days for delivery. PURITY OF GOLD IS IMPORTANT. Hi all. I had been looking into the discussions for quite some time. All appear very interesting. However, it also appears that some bloggers, althought might be aware of some finer aspects of Gold and Investment in Gold, do not intend to provide fuller details of the information. May I add somethin here. As quite a bit of discussion is on Coins, I am rstricting myself to the same. I could not notice any 8216informativeexpert8217 blogger writing anything about the purity of Gold. The 821724 Carat8217 Gold is available in 3 Purities, if not more, 995 Purity 999 Purity and 9999 Purity. E-Glod that is being discussed by Mr. Jain or the Caratlane that is being suggested by Mr. Sandeep both belong to 995 Purity Gold. Which actually is NOT 24 Carat Gold. Though 100 pure gold is highly difficult to achieve, the highest purity that is avaialble is 9999 Purity i.e. 99.99 pure. Thus, actually speaking 24 Carat Gold means 9999 Purity. Today on 22-06-2011, MMTC8217s Selling Price for a 10g 9999 Purity Gold Coin is Rs.24,835.00 in Mumbai actually checked and the Price of a 995 Purity Gold Coin at Caratlane is Rs. 24,015.00 and at the NSEL the price of 10g 995 purity E-Gold is 23,520.00 as displayed on their respective websites. Tanishq is selling the 10g Coin of 9999 purity today at 26,306.00 . So in my opinion the Best Investement would be to buy physical gold of 9999 purity AND NOT JUST 24-Carat from MMTC. Readers may make their research by visiting 2 or 3 showroomsbanksoutlets on the same day and then share with the readers for the benefit of all and not to make this blog for their own benefit. Sudhir, Thanks for your comment just curious to know how this affects selling price Do companies like Tanishq deduct less money while buying back higher purity gold Thanks for reading my views Actually I am only buying at this point in time and have not actually collecteted any info about selling and details thereon. Right now MMTC does not buy back the gold coins. But as I am taking the exercise now for buying and sharing tha info, I shall certainly share when I go and sell my investementspossessions. So can not comment or reply the query now. However, with my contributed infor above, if some readers can add better inouts for buying or selling for better returns, it would benefit larger populace. I checked with the Spot Exchange, but the whole process appears to be too complex and therefore difficult. I asked about selling because that8217s where people are facing issues. So, just wanted to see if you have that figured out or not. Thank you for your comment. gold invest is loss better to invest in bank term depost You may want to be also aware of the difference in Gold purity in 24 Karat. I just checked out the MNC Bullion. which is relatively lower in price, but realized they offer 99.9. while the prices where you might find higher would be is 99.99 purity. Well i guess that makes the Banks and MNC bullion on a level playing field. Here are today8217s prices from different Banks and MNC Bullion: This is 99.9 MNC Bullion. Rs. 124387 for 50 gms Corp Bank. Rs. 121024 for 50 gms Taxes HDFC. Rs. 136178 for 50 gms (Mudra gold. not sure whatz the difference) SBI. Rs. 124500 for 50 gms (not sure about what purity they are offering) Gng to check with GRT Jwellers and Tanishq to know their quotes. Watch out Thanks for the input Venkat 8211 higher purity is good, but the issue with the sale makes me think it8217s simply better to buy a gold ETF. Not knowing how much they will deduct at the time of buying from you, and then creating all kind of hassles on top of that. It8217s just too discouraging. thank u for all, i am getting idea about purchase gold coins I am a regular customer of Gold CoinsBars from MMTC,one of the largest importer of Gold in India. The only limiting point is that MMTC does not have sales outlets other than Metros. Their rates are also quite attractive. How about selling the gold coins Have you tried that, and do they buy it back from you Thanks a lot for a very informative thread. I8217ve a very basic question. I own a bit of physical gold. If the gold does reach (say) twice its price today or more, where will I go and sell it Will even the jewellers buy it back at that price If there8217s any other place to sell it, I8217d love to know. informe me periodically Hi, my parents bought some gold coins from SBI 2 years back, they were not aware about the fact that SBI won8217t buy back the coins. They bought it as an investment for my younger sister. Since banks won8217t buy back now what can they do with it if they want to get a return on it Why are banks selling these coins if they don8217t buy it back You can take it to a jeweler and sell it there or get them to make jewelery. That8217s about the only thing you can do with it. You will have to inquire at a few jewelers to see who gives you the best rate and least deduction. Banks not buying back their gold has become a huge headache as a lot of people are in the same boat as your parents. Banks are trusted source for buying gold coins. By doing a bit of analysis we can save lot of money. We should compare rates among several banks and choose the bank that sells coins at better price. For example today (Sep 6th 2011), 10 grams of gold at Andhra bank cost 30,321.00 but where as HDFC Bank sells at 34,001.00. The difference is close to 700 Rs. This site coziiegold-coin-rates provides a nice comparison report. Can anyone tell which is the best place 2 buy gold in Bangalore. thanks for info can you tell me manshu from where I can buy cheapest gold coins and where can I again sell it. I m new to this market. If you want to buy Gold coinsbars in Bangalore, suggest going to Shubh jewelers 8211 they get gold from Rajesh exports (leading gold and jewelery exporters in India). Shubh doesn8217t charge any extra amount other than 1tax8230no making charges etc. Also, their buy back policy is pretty good as well8230on every gram of 24 carat gold..they deduct INR 51 on that day8217s rate. I have tried it and its great Sorry to say that their claim of 8220no making charge8221 is false. If you compare with prevailing gold rate of the Bangalore market, they charge high, generally their rate for 22 K is approximately equal to that of 24 K rate of market. By this they are charging about 10 more than shown in advertisements. Please check again and write your feedback. Can anyone please advise, the bst place to buy gold from faridabad Hi, Never buy from banks you will end up paying much higher than market rates..Jewelers if trust one then can go ahead but again will end up paying more anyways less than banks. Try Here i feel its the best place to buy physical gold (always good to have it on hand than paper) Bangalore Refinery bangalorerefinery ,8221Bangalore Refinery today is acclaimed for refining nearly 95 of the total gold mined in India8221 They update daily gold prices daily.. From all the above info I observed that buying from either Banks or Post office is not worth rather we should ahead with buying it form jewellers if it is physical gold Please add to my info what exactly is Glod ETF How we can purchase one and what are the minimum units that one should buy what are the other charges other than their market rate as on the date of purchase Where to access more info on the same If we want to convert the same in physical Gold then how to go for that e.g if we wish to get the same for jewelry making Alka 8211 gold ETFs are electronic products like shares which then hold gold. You can8217t convert them to gold ever. You will have to buy and sell them on the stock exchange and that8217s what they are 8211 mutual fund type things that own gold and whose price moves in the same way as gold. Hi Manshu, That is not true anymore. I bumped across a recent (1 month old) news piece, that now you can take physical delivery, if the EFT value goes above 8 gms. Earlier it was 1 kg. Couldn8217t get the news article reference. However, i find this article from hdfc, gives a gist on Gold ETF, except the physcial delivery part. hdfcsecdatadocseducationSampattiGoldETFsimplified.pdf No Venkat I don8217t think that8217s possible. Who will give you the units for gold The ETFs that sell on the stock exchange are secondary units that people like you and I trade. The fund creates units for a kilo and then they are traded on the exchange by someone like you and me so unless you have that many units you can8217t go to the fund and redeem it. 8 grams is pittance when it comes to exchanging it for gold, and because of expenses 1 unit will never actually represent 1 whole gram 8211 it will always be a bit lower. I think you need to recheck your sources. That link you sent is not very helpful as far as understanding the creation and redemption mechanism of ETFs is concerned which is what we are talking about right now. Gitansh, what you are offering is illegal Venkat 8211 thanks for pointing this comment and bringing it to my attention. I will delete it.