[{"_1":2,"_129":-5,"_130":-5},"loaderData",{"_3":4,"_28":29,"_30":31},"root",{"_5":6,"_7":-5,"_8":9},"locale","en","session","ENV",{"_10":11,"_12":13,"_14":15,"_16":17,"_18":19,"_20":21,"_22":23,"_24":25,"_26":27},"APP_ENV","production","APP_URL","https://veritask.ai","GA_MEASUREMENT_ID","G-X1BV3QBZEM","META_PIXEL_ID","4698743733686194","TIKTOK_PIXEL_IDS","D8A3HTBC77U9J3L243V0","CLARITY_PROJECT_ID","wn9rn7xb4l","AMPLITUDE_API_KEY","74a0c7cc1509a379d3647ec140dd375","MIDTRANS_CLIENT_KEY","Mid-client-hwjEU5pmwAKVMbIA","MIDTRANS_SNAP_URL","https://app.midtrans.com/snap/snap.js","routes/$locale",{"_5":6},"routes/$locale.search-engine.regulation.$regulationId",{"_32":33,"_34":35},"regulationId","e303dad8-1db1-48a4-b732-becefb204ec7","regulationData",{"_36":33,"_37":38,"_125":126,"_127":128},"regulation_id","overview",{"_39":40,"_41":42,"_43":44,"_45":46,"_47":48,"_49":50,"_51":52,"_53":54,"_60":61,"_62":63,"_67":68,"_72":73,"_74":75,"_76":77,"_78":79,"_80":-5,"_81":82,"_83":84,"_85":-5,"_86":87,"_88":89,"_90":91,"_92":93,"_100":101,"_106":107,"_108":109,"_110":111,"_112":113,"_114":115,"_116":117,"_118":119,"_120":121,"_122":-5,"_123":124},"title","Peraturan Badan Pengawas Obat dan Makanan Nomor 10 Tahun 2019 tentang Pedoman Pengelolaan Obat-obat Tertentu yang Sering Disalahgunakan","short_title","Peraturan Badan Pengawas Obat dan Makanan Nomor 10 Tahun 2019","number","10","year","2019","published_date","2019-05-20","effective_date","2019-05-22","status_id","89192b77-602e-484c-89df-4fd3166b732a","status",{"_55":52,"_56":57,"_58":59},"id","name","Tidak Berlaku","description","Peraturan yang sudah tidak berlaku karena dicabut, diubah, atau habis masa berlakunya","type_id","6f5779f5-e2ea-448d-8bb0-b22517233239","type",{"_55":61,"_56":64,"_65":66},"Peraturan Badan Pengawas Obat dan Makanan","short_name","Peraturan BPOM","subjects",[69],{"_55":70,"_56":71,"_58":-5},"23186465-8acf-4b27-a795-2d4eddc93459","Standar & Pedoman Teknis","tags",[],"location","Badan Pengawas Obat dan Makanan","place_of_enactment","Jakarta","theme","Pedoman Pengelolaan Obat-obat Tertentu yang Sering Disalahgunakan","subject_matter","abstract","\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n


2019
Peraturan Badan Pengawas Obat dan Makanan NO. 10, BN.2019/No. 591, jdih.pom.go.id : 10 hlm.
Peraturan Badan Pengawas Obat dan Makanan TENTANG Pedoman Pengelolaan Obat-obat Tertentu yang Sering Disalahgunakan
ABSTRAK:	\n \n \n
CATATAN:	\n \n Peraturan Badan Pengawas Obat dan Makanan ini mulai berlaku pada tanggal 22 Mei 2019. \n \n

","regulatory_relationship","Peraturan ini mencabut:\n\nPeraturan Badan Pengawas Obat dan Makanan Nomor 28 Tahun 2018 tentang Pedoman Pengelolaan Obat-Obat Tertentu yang Sering Disalahgunakan (Berita Negara Republik Indonesia Tahun 2018 Nomor 1161).","scope_and_parties","policy_content","

Peraturan Badan Pengawas Obat dan Makanan ini mengatur tentang pengelolaan obat-obat tertentu yang sering disalahgunakan. Latar belakangnya adalah perlunya perlindungan masyarakat dari penyalahgunaan obat-obat tertentu dan pengelolaan yang baik oleh berbagai fasilitas seperti Industri Farmasi, Pedagang Besar Farmasi (PBF), Apotek, Instalasi Farmasi Rumah Sakit, Instalasi Farmasi Klinik, pusat kesehatan masyarakat, dan Toko Obat.

\n\n

Tujuan dari peraturan ini adalah untuk mencegah penyimpangan dan kebocoran obat-obat tertentu. Ruang lingkupnya meliputi pengelolaan obat-obat tertentu di fasilitas produksi (Industri Farmasi), fasilitas distribusi (PBF, PBF Cabang, dan instalasi farmasi), dan Fasilitas Pelayanan Kefarmasian (Apotek, Instalasi Farmasi Rumah Sakit, pusat kesehatan masyarakat, Toko Obat, dan Instalasi Farmasi Klinik).

\n\n

Ketentuan substansial mencakup kriteria obat-obat tertentu (yang mengandung tramadol, triheksifenidil, klorpromazin, amitriptilin, haloperidol, dan/atau dekstrometorfan), yang hanya boleh digunakan untuk kepentingan pelayanan kesehatan dan/atau ilmu pengetahuan. Pengelolaan obat-obat tertentu meliputi pengadaan, penyimpanan, pembuatan, penyaluran, penyerahan, penanganan obat kembalian, penarikan kembali obat, pemusnahan, serta pencatatan dan pelaporan. Toko Obat dilarang mengelola obat keras selain dekstrometorfan. Fasilitas Pelayanan Kefarmasian dilarang menyerahkan obat yang mengandung dekstrometorfan secara langsung kepada anak di bawah 18 tahun.

\n\n

Fasilitas Pelayanan Kefarmasian wajib mengarsipkan secara terpisah seluruh dokumen terkait pengelolaan obat-obat tertentu dan menyerahkan obat-obat tertentu berdasarkan resep atau salinan resep dokter. Tenaga kefarmasian harus mencatat nama, alamat, dan nomor telepon pihak yang mengambil obat.

","transitional_provisions","1. Setiap Industri Farmasi, PBF, Apotek, Instalasi Farmasi Rumah Sakit, Instalasi Farmasi Klinik, dan Toko Obat yang mengelola Bahan Obat dan/atau Obat-Obat Tertentu yang mengandung dekstrometorfan sebelum berlakunya Peraturan Badan ini, wajib menyesuaikan dengan ketentuan dalam Peraturan Badan ini paling lama 1 (satu) tahun terhitung sejak Peraturan Badan ini diundangkan.\n2. Kegiatan pemasukan obat atau Bahan Obat ke dalam wilayah Indonesia sebelum berlakunya Peraturan Badan ini wajib menyesuaikan dengan ketentuan dalam Peraturan Badan ini paling lama 3 (tiga) bulan terhitung sejak Peraturan Badan ini diundangkan.","sanctions","1. Pelanggaran terhadap ketentuan dalam Pasal 5 sampai dengan Pasal 10 Peraturan Badan ini dikenai sanksi administratif berupa:\n a. peringatan lisan;\n b. peringatan keras tertulis;\n c. penghentian sementara kegiatan;\n d. pembatalan persetujuan izin edar;\n e. rekomendasi pencabutan pengakuan PBF Cabang; dan/atau\n f. rekomendasi pencabutan izin.","revokes",[94],{"_95":96,"_97":98,"_36":99},"text","Peraturan BPOM No. 28 Tahun 2018 tentang Pedoman Pengelolaan Obat-Obat Tertentu yang Sering Disalahgunakan","link","https://peraturan.bpk.go.id/Details/219845/peraturan-bpom-no-28-tahun-2018","8a2fb194-dd43-4988-abf3-8bced2440e7a","revoked_by",[102],{"_95":103,"_97":104,"_36":105},"Peraturan BPOM No. 12 Tahun 2025 tentang Obat-Obat Tertentu yang Sering Disalahgunakan","https://peraturan.bpk.go.id/Details/320222/peraturan-bpom-no-12-tahun-2025","a7eeeb27-8f25-42f7-987b-a73586eadf29","partially_revokes",[],"partially_revoked_by",[],"amends",[],"amended_by",[],"partially_amends",[],"partially_amended_by",[],"establishes",[],"established_by",[],"constitutional_review","is_verified",false,"english_excerpt","\n

FOOD AND DRUG ADMINISTRATION
REPUBLIC OF INDONESIA

REGULATION OF THE FOOD AND DRUG ADMINISTRATION
NUMBER 10 OF 2019
ON
GUIDELINES FOR THE MANAGEMENT OF CERTAIN MEDICATIONS THAT ARE FREQUENTLY
MISUSED

WITH THE BLESSINGS OF GOD ALMIGHTY

HEAD OF THE FOOD AND DRUG ADMINISTRATION,

Considering / Whereas :

that in order to protect the public from misuse and incorrect use of certain drugs, more optimal supervision is needed;
that the use of certain drugs that are frequently misused needs to be well managed by Pharmaceutical Industries, Pharmaceutical Wholesalers, Pharmacies, Hospital Pharmacy Installations, Clinical Pharmacy Installations, community health centers, and Drug Stores to prevent irregularities and leakages;
that the provisions on the management of certain drugs that are frequently misused as regulated in the Regulation of the Food and Drug Administration Number 28 of 2018 concerning Guidelines for the Management of

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