Peraturan Badan Pengawas Obat dan Makanan 5/2026 (Peraturan Badan Pengawas Obat dan Makanan Nomor 5 Tahun 2026 tentang Pengawasan Pengelolaan Obat dan Bahan Obat di Fasilitas Pelayanan Kefarmasian dan Fasilitas Lain) is an Indonesian agency regulation of the Food and Drug Supervisory Agency (Badan Pengawas Obat dan Makanan, BPOM) on the supervision of how medicines and drug materials are handled at pharmaceutical service facilities, such as pharmacies and the pharmacy units of hospitals, community health centres and clinics, and at "other facilities": drug stores and self-service retailers. It was signed by the Head of BPOM on 13 March 2026 and took effect on its promulgation on 6 April 2026.^[1][2] It forms part of health sector regulation in Indonesia and was issued to implement Pasal 417 ayat (4) of Peraturan Pemerintah Nomor 28 Tahun 2024, the implementing regulation of the 2023 health law.^[3]

The regulation sets out which facilities may handle which classes of medicine, places each facility's handling of medicines under a responsible professional, and gives BPOM officers routine and incidental powers of inspection. It prohibits certain activities at each type of facility, provides for administrative sanctions, and requires findings of suspected drug offences to be passed to investigators.^{[4][5][6][7][8]} Its annex is a guideline on each stage of handling, from procurement to reporting.^[9][10]

The regulation replaced Peraturan BPOM Nomor 24 Tahun 2021, which had covered medicines, drug materials, narcotics, psychotropics and pharmaceutical precursors at pharmaceutical service facilities only, and gave hypermarkets, supermarkets and minimarkets until 17 October 2026 to comply.^[11][12] CRPG's regulatory tracker published a summary of the regulation on 2 September 2026.^[13]

¶ Background

The preamble cites three grounds: the need to protect the public from medicines and drug materials that do not meet safety, efficacy and quality requirements and from deviations in their handling; the finding that the 2021 regulation no longer matched legal developments; and BPOM's function, under Pasal 3 ayat (1) huruf d of Peraturan Presiden Nomor 80 Tahun 2017 on the agency, of supervising products before and during their circulation.^[3:1] The introduction to the annex explains that the health law, Undang-Undang Nomor 17 Tahun 2023, and Peraturan Pemerintah Nomor 28 Tahun 2024 had recognised entities outside pharmaceutical service facilities, the "other facilities", that may handle medicines, and that the 2021 regulation had to be updated to cover them.^[10:1]

¶ Scope and definitions

Pasal 1 defines a medicine (obat) as a material or combination of materials, including biological products, used to affect or investigate physiological systems or pathological states for diagnosis, prevention, cure, recovery, health improvement and contraception in humans, and a drug material (bahan obat) as an active or inactive material used in making medicines to pharmaceutical standards. It also defines narcotics, psychotropics and pharmaceutical precursors, the last by reference to products containing ephedrine, pseudoephedrine, norephedrine or phenylpropanolamine, ergotamine, ergometrine or potassium permanganate.^[14] Under Pasal 2, the medicines covered are prescription medicines (narcotics, psychotropics and obat keras, hard drugs) and non-prescription medicines (limited over-the-counter and over-the-counter medicines, the former including those containing precursors); narcotics, psychotropics and precursors are covered only as finished products.^[15]

Pasal 4 requires every facility that handles medicines to hold a business licence. Pharmaceutical service facilities are hospital, community health centre (puskesmas) and clinic pharmacy units and pharmacies; other facilities are drug stores (toko obat) and three kinds of modern retail store: hypermarkets, supermarkets and minimarkets.^[4:1] The annex distinguishes the three kinds of self-service retailer by sales floor area: above 5,000 square metres, from 400 to 5,000 square metres, and up to 400 square metres.^[10:2]

¶ Handling of medicines

Pasal 5 lists the stages of handling at pharmaceutical service facilities: procurement, receipt, storage, compounding, dispensing, return, destruction and reporting. Other facilities follow the same stages without compounding, and may handle only over-the-counter and limited over-the-counter medicines, including those containing precursors.^[4:2] Every stage must follow the guideline in the annex, and pharmaceutical service facilities must also follow the pharmaceutical service standards, while self-service retailers follow the health minister's guideline on the distribution and dispensing of over-the-counter medicines.^[9:1]

Each class of facility has its own responsible person. At pharmaceutical service facilities all handling is the responsibility of a pharmacist in charge (apoteker penanggung jawab), who may be assisted by other pharmaceutical staff, all holding practice permits; at drug stores it rests with a licensed pharmacy technician (tenaga vokasi farmasi); and at hypermarkets, supermarkets and minimarkets with a health support worker holding a training certificate.^[5:1] Pasal 10 provides that handling at the village and urban-ward pharmacies and clinics run under the koperasi desa merah putih village cooperatives follows technical guidance issued by the health minister.^[16]

The annex sets out each stage in detail for three regimes: medicines and drug materials at pharmaceutical service facilities; narcotics, psychotropics and precursors at those facilities; and over-the-counter medicines at other facilities.^[10:3] It requires pharmaceutical service facilities to procure medicines from licensed pharmaceutical manufacturers and wholesalers (pedagang besar farmasi), and permits procurement through electronic systems and e-commerce operators in accordance with the law.^[17] It allows a drug store to partner with up to five hypermarkets, supermarkets or minimarkets in the same regency or city.^[10:4]

¶ Supervision

Pasal 11 requires each facility's responsible person to supervise its handling of medicines, and Pasal 12 provides for supervision by the Head of BPOM, either routine, through the examination of reports and routine field inspections, or incidental, at particular times. Field inspections are carried out by officers (petugas), civil servants assigned to the task, who may examine documents, premises and licences, take data and documents including images, photographs and video, carry out verification, clarification and assessment, take on-site securing measures, and issue recommendations.^[14:1][6:1] Under Pasal 13 an officer must carry a letter of assignment and an identity card, and the person responsible for the premises may refuse an inspection by an officer who does not carry them.^[18] Supervision may be coordinated with other agencies and may include monitoring, technical guidance and capacity building.^[19] Where supervision indicates a suspected criminal offence concerning medicines, including one concerning narcotics, psychotropics or precursors, the officer must coordinate promptly with criminal investigators in accordance with the law.^[7:1]

¶ Prohibitions and sanctions

Pasal 18 to Pasal 21 prohibit every facility from procuring or dispensing medicines that fail safety, efficacy and quality requirements; prohibit community health centre and clinic pharmacy units, pharmacies and other facilities from producing medicines; prohibit pharmaceutical service facilities from handling narcotics, psychotropics or precursors in the form of drug materials; and prohibit other facilities from handling narcotics, psychotropics, drug materials or hard drugs and from compounding or repacking medicines.^[7:2]

Breaches of the listed obligations and prohibitions attract administrative sanctions under Pasal 22: a warning, a strong warning or the temporary suspension of activities, imposed by the Head of BPOM. The Head may also recommend to the ministry, agency or regional government that issued the facility's business licence that the licence be revoked. The procedure follows BPOM's regulation on the follow-up of supervision findings.^[8:1]

¶ Transition and repeal

Under Pasal 24, hypermarkets, supermarkets and minimarkets must bring their handling of medicines into line with Pasal 5 by 17 October 2026, and drug stores must bring their supply of medicines to those retailers into line with the regulation by the same date.^[11:1] Pasal 25 revokes Peraturan BPOM Nomor 24 Tahun 2021, and Pasal 26 brings the regulation into force on its promulgation.^[12:1][2:1] The regulation has seven chapters and twenty-six articles.^[1:1]

¶ See also

• Peraturan BPOM 10/2026
• Permenkes 5/2026

¶ External links

• Peraturan BPOM No. 5 Tahun 2026 (JDIH BPK)
• CRPG: Oversight of Medicine Handling at Pharmacy Service Facilities: PERATURAN BPOM 5/2026 (crpg.id, 2 September 2026)

¶ References