[{"_1":2,"_119":-5,"_120":-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","238df093-e1bb-4a6d-ae84-03762f348437","regulationData",{"_36":33,"_37":38,"_115":116,"_117":118},"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,"_94":95,"_96":97,"_98":99,"_100":101,"_102":103,"_104":105,"_106":107,"_108":109,"_110":111,"_112":-5,"_113":114},"title","Peraturan Badan Pengawas Obat dan Makanan Nomor 24 Tahun 2021 tentang Pengawasan Pengelolaan Obat, Bahan Obat, Narkotika, Psikotropika, dan Prekursor Farmasi di Fasilitas Pelayanan Kefarmasian","short_title","Peraturan Badan Pengawas Obat dan Makanan Nomor 24 Tahun 2021","number","24","year","2021","published_date","2021-10-13","effective_date","2021-10-14","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},"e45b1363-11cb-4a11-b70b-f69c41a05334","Pemberantasan Narkotika","tags",[],"location","Badan Pengawas Obat dan Makanan","place_of_enactment","Jakarta","theme","Pengawasan Pengelolaan Obat, Bahan Obat, Narkotika, Psikotropika, dan Prekursor Farmasi di Fasilitas Pelayanan Kefarmasian","subject_matter","abstract","\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n


2021
Peraturan Badan Pengawas Obat dan Makanan NO. 24, BN.2021/No.1152, peraturan.go.id: 12 hlm.
Peraturan Badan Pengawas Obat dan Makanan TENTANG Pengawasan Pengelolaan Obat, Bahan Obat, Narkotika, Psikotropika, dan Prekursor Farmasi di Fasilitas Pelayanan Kefarmasian
ABSTRAK:	\n \n \n
CATATAN:	\n \n Peraturan Badan Pengawas Obat dan Makanan ini mulai berlaku pada tanggal 14 Oktober 2021. \n \n

","regulatory_relationship","Peraturan Badan Pengawas Obat dan Makanan Nomor 4 Tahun 2018 tentang Pengawasan Pengelolaan Obat, Bahan Obat, Narkotika, Psikotropika, dan Prekursor Farmasi di Fasilitas Pelayanan Kefarmasian (Berita Negara Republik Indonesia Tahun 2018 Nomor 636) dicabut dan dinyatakan tidak berlaku.","scope_and_parties","policy_content","

Peraturan Badan ini mengatur tentang pengawasan pengelolaan obat, bahan obat, narkotika, psikotropika, dan prekursor farmasi di fasilitas pelayanan kefarmasian. Pengawasan ini bertujuan untuk melindungi masyarakat dari risiko produk yang tidak terjamin keamanan, khasiat, dan mutu, serta penyimpangan dalam pengelolaannya.

Latar Belakang dan Tujuan: Peraturan ini diterbitkan karena peraturan sebelumnya (Peraturan BPOM Nomor 4 Tahun 2018) dianggap tidak sesuai lagi dengan kebutuhan hukum. Tujuannya adalah untuk memperkuat pengawasan terhadap pengelolaan obat-obatan dan bahan berbahaya di fasilitas pelayanan kefarmasian.

Ketentuan Substansial:

Fasilitas Pelayanan Kefarmasian: Wajib memiliki izin usaha yang sesuai.
Obat dan Bahan Berbahaya: Harus memiliki izin edar dan memenuhi persyaratan keamanan, khasiat, dan mutu.
Pengawasan: Dilakukan terhadap pengadaan, penerimaan, penyimpanan, penyerahan, pengembalian, pemusnahan, dan pelaporan.
Tanggung Jawab Apoteker: Seluruh kegiatan pengelolaan harus berada di bawah tanggung jawab seorang Apoteker penanggung jawab.
Standar Pelayanan Kefarmasian: Kegiatan pengelolaan wajib mengacu pada standar pelayanan kefarmasian yang berlaku.
Pemantauan dan Pembinaan: Badan Pengawas Obat dan Makanan melakukan pemantauan, bimbingan teknis, dan pembinaan.
Pemeriksaan: Pengawasan dilakukan melalui pemeriksaan oleh petugas yang berwenang.

Peraturan ini juga mengatur kewenangan petugas dalam melakukan pemeriksaan, serta sanksi administratif bagi fasilitas pelayanan kefarmasian yang melanggar ketentuan.

","transitional_provisions","(-)","sanctions","1. Fasilitas Pelayanan Kefarmasian yang melanggar ketentuan Pasal 3 ayat (1), Pasal 3 ayat (2), Pasal 5, Pasal 6 ayat (1), Pasal 7, Pasal 8 dan/atau Pasal 9 dikenai sanksi administratif berupa:\n a. peringatan tertulis;\n b. penghentian sementara kegiatan; dan/atau\n c. pencabutan izin.","revokes",[],"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

STATE GAZETTE
REPUBLIC OF INDONESIA

No.1152, 2021
BPOM. Drug Ingredients. Narcotics. Psychotropics. Pharmaceutical Precursors. Pharmaceutical Service Facilities. Supervision of Drug Management. Revocation.

REGULATION OF THE FOOD AND DRUG CONTROL AGENCY
NUMBER 24 OF 2021
CONCERNING
SUPERVISION OF THE MANAGEMENT OF DRUGS, DRUG INGREDIENTS,
NARCOTICS, PSYCHOTROPICS, AND PHARMACEUTICAL PRECURSORS
IN PHARMACEUTICAL SERVICE FACILITIES

BY THE GRACE OF GOD ALMIGHTY

HEAD OF THE FOOD AND DRUG CONTROL AGENCY,

\n\n \n \n

Considering:

that the public needs to be protected from the risks of drugs, drug ingredients, narcotics, psychotropics, and pharmaceutical precursors whose safety, efficacy, and quality are not guaranteed, as well as deviations in the management of drugs, drug ingredients, narcotics, psychotropics, and pharmaceutical precursors;
that based on the provisions of Article 3 paragraph (1)

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