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Buku 02-Perka BPOM 2019.Pdf PERATURAN BADAN PENGAWAS OBAT DAN MAKANAN DAN OBAT PENGAWAS BADAN PERATURAN PERATURAN BADAN PENGAWAS OBAT DAN MAKANAN TAHUN 2019 Buku 2 TAHUN 2019 TAHUN Buku 2 PERATURAN BADAN PENGAWAS OBAT DAN MAKANAN TAHUN 2019 Buku 2 KATA PENGANTAR KATA PENGANTAR Puji syukur ke hadirat Allah SWT, sehingga Biro Hukum dan Organisasi dapat menerbitkan Buku II Peraturan Badan Pengawas Obat dan Makanan Tahun 2019. Bersamaan dengan Buku ini, telah diterbitkan pula Buku I Peraturan Badan Pengawas Obat dan Makanan Tahun 2019. Buku Peraturan Badan Pengawas Obat dan Makanan Tahun 2019 ini diterbitkan dalam rangka pelaksanaan tugas dan fungsi dokumentasi dan informasi peraturan perundang-undangan bidang pengawasan Obat dan Makanan. Penerbitan Buku/Himpunan Peraturan Perundang-undangan Bidang Pengawasan Obat dan Makanan telah dilaksanakan pada tiap-tiap tahun dan diharapkan dapat memberikan informasi kepada pemangku kepentingan sehingga peraturan perundang-undangan bidang pengawasan Obat dan Makanan dapat diimplementasikan guna mendukung visi BPOM yaitu “Obat dan Makanan Aman Meningkatkan Kesehatan Masyarakat dan Daya Saing Bangsa”. Diinformasikan pula bahwa BPOM memiliki Jaringan Dokumentasi dan Informasi Hukum dengan alamat www.jdih.pom.go.id dimana produk peraturan perundang-undangan bidang pengawasan obat dan makanan juga dapat diunduh pada website tersebut. Dengan terbitnya Buku ini, diharapkan peraturan perundang- undangan bidang pengawasan Obat dan Makanan tersebut dapat tersosialisasi dan bermanfaat serta dipergunakan sebagaimana mestinya. Jakarta, Oktober 2019 Kepala Biro Hukum dan Organisasi ttd Riati Anggriani, SH., MARS., M.Hum. Buku 2 – Peraturan BPOM Tahun 2019 iii DAFTAR ISI Kata Pengantar .................................................... iii Daftar Isi ........................................................... iv 1. Peraturan Badan Pengawas Obat dan Makanan Nomor 9 Tahun 2019 tentang Pedoman Teknis Cara Distribusi Obat Yang Baik ................................. 1 • Lampiran Peraturan Badan Pengawas Obat dan Makanan Republik Indonesia Nomor 9 Tahun 2019 tentang Pedoman Teknis Cara Distribusi Obat Yang Baik ......................................... 7 2. Peraturan Badan Pengawas Obat dan Makanan Nomor 10 Tahun 2019 tentang Pedoman Pengelolaan Obat-Obat Tertentu Yang Sering Disalahgunakan ...................... 71 • Lampiran Peraturan Badan Pengawas Obat dan Makanan Nomor 10 Tahun 2019 tentang Pedoman Pengelolaan Obat-Obat Tertentu Yang Sering Disalahgunakan ......................................... 81 3. Peraturan Badan Pengawas Obat dan Makanan Nomor 12 Tahun 2019 tentang Cemaran dalam Kosmetika ................................................... 107 • Lampiran Peraturan Badan Pengawas Obat dan Makanan Nomor 12 Tahun 2019 tentang Cemaran dalam Kosmetika ........................................ 114 4. Peraturan Badan Pengawas Obat dan Makanan Nomor 13 Tahun 2019 tentang Batas Maksimal Cemaran Mikroba dalam Pangan Olahan ............................. 117 • Lampiran Peraturan Badan Pengawas Obat dan Makanan Nomor 13 Tahun 2019 tentang Batas Maksimal Cemaran Mikroba Dalam Pangan Olahan .... 124 iv Buku 2 – Peraturan BPOM Tahun 2019 5. Peraturan Badan Pengawas Obat dan Makanan Nomor 14 Tahun 2019 tentang Penarikan Dan Pemusnahan Obat Yang Tidak Memenuhi Standar Dan/Atau Persyaratan Keamanan, Khasiat, Mutu, dan Label ...................... 169 6. Peraturan Badan Pengawas Obat dan Makanan Nomor 15 Tahun 2019 tentang Perubahan atas Peraturan Kepala Badan Pengawas Obat dan Makanan Nomor 24 Tahun 2017 tentang Kriteria dan Tata Laksana Registrasi Obat .................. 187 • Lampiran Peraturan Badan Pengawas Obat dan Makanan Nomor 15 Tahun 2019 tentang Perubahan atas Peraturan Kepala Badan Pengawas Obat dan Makanan Nomor 24 Tahun 2017 tentang Kriteria dan Tata Laksana Registrasi Obat ....................... 194 7. Peraturan Badan Pengawas Obat dan Makanan Nomor 16 Tahun 2019 tentang Pengawasan Suplemen Kesehatan ................................................... 197 8. Peraturan Badan Pengawas Obat dan Makanan Nomor 17 Tahun 2019 tentang Persyaratan Mutu Suplemen Kesehatan ....................................... 209 • Lampiran I Peraturan Badan Pengawas Obat dan Makanan Nomor 17 Tahun 2019 tentang Persyaratan Mutu Suplemen Kesehatan .............................. 219 • Lampiran II Peraturan Badan Pengawas Obat dan Makanan Nomor 17 Tahun 2019 tentang Persyaratan Mutu Suplemen Kesehatan .............................. 220 • Lampiran III Peraturan Badan Pengawas Obat dan Makanan Nomor 17 Tahun 2019 tentang Persyaratan Mutu Suplemen Kesehatan .............................. 221 • Lampiran IV Peraturan Badan Pengawas Obat dan Makanan Nomor 17 Tahun 2019 tentang Persyaratan Mutu Suplemen Kesehatan .............................. 232 • Lampiran V Peraturan Badan Pengawas Obat dan Makanan Nomor 17 Tahun 2019 tentang Persyaratan Mutu Suplemen Kesehatan .............................. 236 Buku 2 – Peraturan BPOM Tahun 2019 v • Lampiran VI Peraturan Badan Pengawas Obat dan Makanan Nomor 17 Tahun 2019 tentang Persyaratan Mutu Suplemen Kesehatan .............................. 237 9. Peraturan Badan Pengawas Obat dan Makanan Nomor 18 Tahun 2019 tentang Cara Iradiasi Pangan Yang Baik ................................................... 243 • Lampiran Peraturan Badan Pengawas Obat dan Makanan Nomor 18 Tahun 2019 tentang Pedoman Cara Iradiasi Pangan Yang Baik ........................ 247 10. Peraturan Badan Pengawas Obat dan Makanan Nomor 19 Tahun 2019 tentang Pedoman Cara Produksi Yang Baik untuk Pangan Steril Komersial Yang Diolah dan Dikemas Secara Aseptik ........................ 257 • Lampiran Peraturan Badan Pengawas Obat dan Makanan Nomor 19 Tahun 2019 tentang Pedoman Cara Produksi Yang Baik untuk Pangan Steril Komersial Yang Diolah dan Dikemas Secara Aseptik ..................... 261 11. Peraturan Badan Pengawas Obat dan Makanan Nomor 20 Tahun 2019 tentang Kemasan Pangan ..................... 309 • Lampiran I Peraturan Badan Pengawas Obat dan Makanan Nomor 20 Tahun 2019 tentang Kemasan Pangan .................................................. 317 • Lampiran II Peraturan Badan Pengawas Obat dan Makanan Nomor 20 Tahun 2019 tentang Kemasan Pangan ........................................ 329 • Lampiran III Peraturan Badan Pengawas Obat dan Makanan Nomor 20 Tahun 2019 tentang Kemasan Pangan ........................................ 451 • Lampiran IV Peraturan Badan Pengawas Obat dan Makanan Nomor 20 Tahun 2019 tentang Kemasan Pangan ........................................ 489 • Lampiran V Peraturan Badan Pengawas Obat dan Makanan Nomor 20 Tahun 2019 tentang Kemasan Pangan ........................................ 515 vi Buku 2 – Peraturan BPOM Tahun 2019 1 Peraturan Badan Pengawas Obat dan Makanan Nomor 9 Tahun 2019 tentang Pedoman Teknis Cara Distribusi Obat Yang Baik BADAN PENGAWAS OBAT DAN MAKANAN REPUBLIK INDONESIA PERATURAN BADAN PENGAWAS OBAT DAN MAKANAN NOMOR 9 TAHUN 2019 TENTANG PEDOMAN TEKNIS CARA DISTRIBUSI OBAT YANG BAIK DENGAN RAHMAT TUHAN YANG MAHA ESA KEPALA BADAN PENGAWAS OBAT DAN MAKANAN, Menimbang : a. bahwa untuk menjamin keamanan, khasiat, dan mutu obat beredar, perlu menerapkan pedoman cara distribusi obat yang baik dalam setiap aspek dan rangkaian distribusi obat; b. bahwa beberapa ketentuan mengenai distribusi narkotika dan psikotropika dalam Peraturan Kepala Badan Pengawas Obat dan Makanan Nomor HK.03.1.34.11.12.7542 Tahun 2012 tentang Pedoman Teknis Cara Distribusi Obat yang Baik sudah tidak sesuai dengan ketentuan terkini di bidang distribusi obat khususnya ketentuan dalam Lampiran Aneks III sehingga perlu diganti; c. bahwa berdasarkan pertimbangan sebagaimana dimaksud dalam huruf a dan huruf b, perlu menetapkan Peraturan Badan Pengawas Obat dan Makanan tentang Pedoman Teknis Cara Distribusi Obat yang Baik; Mengingat : 1. Peraturan Presiden Nomor 80 Tahun 2017 tentang Badan Pengawas Obat dan Makanan (Lembaran Negara Republik Indonesia Tahun 2017 Nomor 180); Peraturan BPOM No. 9 Tahun 2019 1 2. Peraturan Badan Pengawas Obat dan Makanan Nomor 26 Tahun 2017 tentang Organisasi dan Tata Kerja Badan Pengawas Obat dan Makanan (Berita Negara Republik Indonesia Tahun 2017 Nomor 1745); 3. Peraturan Badan Pengawas Obat dan Makanan Nomor 12 Tahun 2018 tentang Organisasi dan Tata Kerja Unit Pelaksana Teknis di Lingkungan Badan Pengawas Obat dan Makanan (Berita Negara Republik Indonesia Tahun 2018 Nomor 784); MEMUTUSKAN: Menetapkan : PERATURAN BADAN PENGAWAS OBAT DAN MAKANAN TENTANG PEDOMAN TEKNIS CARA DISTRIBUSI OBAT YANG BAIK. BAB I KETENTUAN UMUM Pasal 1 Dalam Peraturan Badan ini yang dimaksud dengan: 1. Cara Distribusi Obat yang Baik yang selanjutnya disingkat CDOB adalah cara distribusi/penyaluran obat dan/atau bahan obat yang bertujuan memastikan mutu sepanjang jalur distribusi/penyaluran sesuai persyaratan dan tujuan penggunaannya. 2. Industri Farmasi adalah badan usaha yang memiliki izin sesuai dengan ketentuan peraturan perundang- undangan untuk melakukan kegiatan pembuatan Obat atau Bahan Obat. 3. Pedagang Besar Farmasi yang selanjutnya disingkat PBF adalah perusahaan berbentuk badan hukum yang memiliki izin untuk pengadaan, penyimpanan, penyaluran obat dan/atau bahan obat dalam jumlah besar sesuai ketentuan peraturan perundang- undangan. 4. PBF Cabang adalah cabang PBF yang telah memiliki pengakuan untuk melakukan pengadaan, penyimpanan, penyaluran obat dan/atau bahan obat dalam jumlah besar sesuai ketentuan peraturan perundang-undangan. 2 Buku 2 – Peraturan BPOM Tahun 2019 5. Instalasi Sediaan Farmasi yang disebut juga Instalasi Farmasi
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