[{"_1":2,"_125":-5,"_126":-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","a7eeeb27-8f25-42f7-987b-a73586eadf29","regulationData",{"_36":33,"_37":38,"_121":122,"_123":124},"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,"_102":103,"_104":105,"_106":107,"_108":109,"_110":111,"_112":113,"_114":115,"_116":117,"_118":-5,"_119":120},"title","Peraturan Badan Pengawas Obat dan Makanan Nomor 12 Tahun 2025 tentang Obat-Obat Tertentu yang Sering Disalahgunakan","short_title","Peraturan Badan Pengawas Obat dan Makanan Nomor 12 Tahun 2025","number","12","year","2025","published_date","2025-04-23","effective_date","2025-05-02","status_id","3611a577-44a0-41ad-986d-7457e14f52ff","status",{"_55":52,"_56":57,"_58":59},"id","name","Berlaku","description","Peraturan yang masih berlaku dan memiliki kekuatan hukum yang mengikat","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},"10e70ff8-158d-4e9e-849e-554938c706d9","Pelayanan Kesehatan","tags",[],"location","Badan Pengawas Obat dan Makanan","place_of_enactment","Jakarta","theme","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

Obat-Obat Tertentu - Sering Disalahgunakan
2025
Peraturan Badan Pengawas Obat dan Makanan NO. 12, BN 2025 (300); 8 hlm
Peraturan Badan Pengawas Obat dan Makanan TENTANG Obat-Obat Tertentu yang Sering Disalahgunakan
ABSTRAK:	\n \n bahwa Peraturan Badan Pengawas Obat dan Makanan\r\nNomor 10 Tahun 2019 tentang Pedoman Pengelolaan\r\nObat-Obat Tertentu yang Sering Disalahgunakan sudah\r\ntidak sesuai dengan kebutuhan hukum, sehingga perlu\r\ndiganti \n Dasar hukum peraturan ini adalah Perpres Nomor 80 Tahun 2017; Peraturan BPOM Nomor 21 Tahun 2020 sebagaimana telah diubah dengan Peraturan BPOM Nomor 13 Tahun 2022; Peraturan BPOM Nomor 13 Tahun 2022; Peraturan BPOM Nomor 19 Tahun 2023 \n Peraturan ini mengatur mengenai obat-obatan tertentu yang merupakan Obat atau Bahan Obat yang mengandung bahan aktif; industri farmasi,Pedagang Besar Farmasi, Pedagang Besar Farmasi Cabang, Fasilitas \r\nPengelolaan Kefarmasian, fasilitas pelayanan\r\nkefarmasian, dan/atau fasilitas lain dalam melakukan\r\nkegiatan peredaran Obat-Obat Tertentu; Kegiatan pengadaan, penyimpanan, dan/atau penyaluran Obat-Obat Tertentu; Sanksi pelanggaran \n \n
CATATAN:	\n \n Peraturan Badan Pengawas Obat dan Makanan ini mulai berlaku pada tanggal 02 Mei 2025. \n 8 hlm \n \n

","regulatory_relationship","Peraturan ini mencabut:\n1. Peraturan Badan Pengawas Obat dan Makanan Nomor 10 Tahun 2019 tentang Pedoman Pengelolaan Obat-Obat Tertentu yang sering Disalahgunakan (Berita Negara Republik Indonesia Tahun 2019 Nomor 591)","scope_and_parties","policy_content","

Latar Belakang dan Tujuan: Peraturan ini dibuat untuk melindungi masyarakat dari penyalahgunaan obat-obat tertentu yang berisiko terhadap kesehatan. Pengawasan optimal diperlukan untuk obat-obat yang sering disalahgunakan. Peraturan ini menggantikan Peraturan Badan Pengawas Obat dan Makanan Nomor 10 Tahun 2019 yang sudah tidak sesuai dengan kebutuhan hukum.

Ketentuan Substansial: Peraturan ini mengatur pengawasan terhadap obat-obat tertentu yang sering disalahgunakan, seperti tramadol, triheksifenidil, dan lainnya. Industri farmasi, PBF, dan fasilitas kefarmasian wajib memastikan distribusi obat hanya untuk kepentingan kesehatan dan ilmu pengetahuan. Pemusnahan obat yang tidak memenuhi standar atau kedaluwarsa harus dilakukan. Laporan kehilangan obat wajib disampaikan kepada Kepala Badan. Sanksi administratif dikenakan bagi pelanggaran ketentuan ini.

","transitional_provisions","1. Industri Farmasi, PBF, PBF Cabang, Fasilitas Pengelolaan Kefarmasian, dan/atau fasilitas pelayanan kefarmasian yang mengelola Obat-Obat Tertentu berupa ketamin sebelum berlakunya Peraturan Badan ini wajib menyesuaikan dengan ketentuan dalam Peraturan Badan ini paling lambat 6 (enam) bulan terhitung sejak Peraturan Badan ini diundangkan.","sanctions","1. Pelanggaran terhadap Pasal 3 ayat (1), Pasal 4, Pasal 5 ayat (1), Pasal 7 ayat (1), Pasal 8, Pasal 9 ayat (1), Pasal 9 ayat (2), dan/atau Pasal 10 ayat (1) dikenai sanksi administratif.\n2. Sanksi administratif berupa peringatan, peringatan keras, penghentian sementara kegiatan, pembekuan izin edar, pembekuan sertifikat cara pembuatan obat yang baik, pencabutan izin edar, pencabutan sertifikat cara pembuatan obat yang baik, pencabutan sertifikat cara distribusi obat yang baik, larangan mengedarkan untuk sementara waktu, perintah untuk penarikan kembali dari peredaran, perintah pemusnahan atau pengiriman kembali/re-ekspor, dan/atau penutupan akses pengajuan permohonan perizinan berusaha untuk sementara waktu.","revokes",[94],{"_95":96,"_97":98,"_36":99},"text","Peraturan BPOM No. 10 Tahun 2019 tentang Pedoman Pengelolaan Obat-obat Tertentu yang Sering Disalahgunakan","link","https://peraturan.bpk.go.id/Details/182037/peraturan-bpom-no-10-tahun-2019","e303dad8-1db1-48a4-b732-becefb204ec7","revoked_by",[],"partially_revokes",[],"partially_revoked_by",[],"amends",[],"amended_by",[],"partially_amends",[],"partially_amended_by",[],"establishes",[],"established_by",[],"constitutional_review","is_verified",false,"english_excerpt","\n

REGULATION OF THE FOOD AND DRUG CONTROL AGENCY
NUMBER 12 OF 2025
ABOUT
CERTAIN MEDICINES THAT ARE OFTEN MISUSED

BY THE GRACE OF GOD ALMIGHTY

HEAD OF THE FOOD AND DRUG CONTROL AGENCY,

\n\n \n \n

Considering:

that to protect the public from misuse of certain medicines that pose a risk to health, it is necessary to optimally supervise certain medicines that are often misused;
that based on the provisions of Article 3 paragraph (1) letter d of Presidential Regulation Number 80 of 2017 concerning the Food and Drug Control Agency, the Food and Drug Control Agency carries out the function of implementing pre-market and post-market supervision;
that Regulation of the Food and Drug Control Agency Number 10 of 2019 concerning Guidelines for the Management of Certain Medicines that are Often Misused is no longer in accordance with legal needs, so it needs to be replaced;
that based

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