[{"_1":2,"_110":-5,"_111":-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,"_106":107,"_108":109},"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":86,"_87":88,"_89":90,"_91":92,"_93":-5,"_94":-5,"_95":-5,"_96":-5,"_97":-5,"_98":-5,"_99":-5,"_100":-5,"_101":-5,"_102":-5,"_103":-5,"_104":105},"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 \n \n \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) letter d of Presidential Regulation Number 80 of 2017 concerning the Food and Drug Control Agency, the Food and Drug Control Agency has the function of carrying out pre-market supervision and post-market supervision;
that Regulation of the Food and Drug Control Agency Number 4 of 2018 concerning Supervision of the Management of Drugs, Drug Ingredients, Narcotics, Psychotropics, and Pharmaceutical Precursors in Pharmaceutical Service Facilities is no longer in accordance with legal needs, so it needs to be replaced;
that based on the considerations as referred to in letters a to c, it is necessary to stipulate a Regulation of the Food and Drug Control Agency concerning Supervision of the Management of Drugs, Drug Ingredients, Narcotics, Psychotropics, and Pharmaceutical Precursors in Pharmaceutical Service Facilities;

In view of:

Government Regulation Number 51 of 2009 concerning Pharmaceutical Work (State Gazette of the Republic of Indonesia of 2009 Number 124, Supplement to the State Gazette of the Republic of Indonesia Number 5044);
Government Regulation Number 40 of 2013 concerning the Implementation of Law Number 35 of 2009 concerning Narcotics (State Gazette of the Republic of Indonesia of 2013 Number 96, Supplement to the State Gazette of the Republic of Indonesia Number 5419);
Government Regulation Number 5 of 2021 concerning the Implementation of Risk-Based Business Licensing (State Gazette of the Republic of Indonesia Number 2021 Number 15, Supplement to the State Gazette of the Republic of Indonesia Number 6617);
Presidential Regulation Number 80 of 2017 concerning the Food and Drug Control Agency (State Gazette of the Republic of Indonesia of 2017 Number 180);
Regulation of the Minister of Health Number 9 of 2014 concerning Clinics (State Gazette of the Republic of Indonesia of 2014 Number 232);
Regulation of the Minister of Health Number 3 of 2015 concerning the Circulation, Storage, Destruction, and Reporting of Narcotics, Psychotropics, and Pharmaceutical Precursors (State Gazette of the Republic of Indonesia Number 2015 Number 74);
Regulation of the Minister of Health Number 72 of 2016 concerning Pharmaceutical Service Standards in Hospitals (State Gazette of the Republic of Indonesia Number 2017 Number 49);
Regulation of the Minister of Health Number 73 of 2016
concerning Pharmaceutical Service Standards in Pharmacies (State Gazette\nta Negara Republik Indonesia Tahun 2017 Nomor 50);
Peraturan Menteri Kesehatan Nomor 74 Tahun 2016 tentang Standar Pelayanan Kefarmasian di Puskesmas (Berita Negara Republik Indonesia Tahun 2016 Nomor 206) sebagaimana telah diubah dengan Peraturan Menteri Kesehatan Nomor 26 Tahun 2020 tentang Perubahan atas Peraturan Menteri Kesehatan Nomor 74 Tahun 2016 tentang Standar Pelayanan Kefarmasian di Puskesma (Berita Negara Republik Indonesia Tahun 2020 Nomor 1206);
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);
Peraturan Badan Pengawas Obat dan Makanan Nomor 21 Tahun 2020 tentang Organisasi dan Tata Kerja Badan Pengawas Obat dan Makanan (Berita Negara Republik Indonesia Tahun 2020 Nomor 1002);
Peraturan Badan Pengawas Obat dan Makanan Nomor 22 Tahun 2020 tentang Organisasi dan Tata Kerja Unit Pelaksana Teknis di Lingkungan Badan Pengawas Obat dan Makanan (Berita Negara Republik Indonesia Tahun 2020 Nomor 1003) sebagaimana telah diubah dengan Peraturan Badan Pengawas Obat dan Makanan Nomor 23 Tahun 2021 tentang Perubahan atas Peraturan Menteri Kesehatan Nomor 22 Tahun 2020 tentang Organisasi dan Tata Kerja Unit Pelaksana Teknis di Lingkungan Badan Pengawas Obat dan Makanan (Berita Negara Republik Indonesia Tahun 2021 Nomor 1151);

DECIDES:

\n\n \n \n \n \n \n \n

Establishes:

REGULATION OF THE FOOD AND DRUG CONTROL AGENCY
ON SUPERVISION OF MANAGEMENT OF DRUGS, DRUG
INGREDIENTS, NARCOTICS, PSYCHOTROPICS, AND PHARMACEUTICAL
PRECURSORS IN PHARMACEUTICAL SERVICE FACILITIES.

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