BPOM Regulation Number 5 of 2026 Governs the Supervision of Drug Management in Supermarkets and Minimarkets

Introduction

On 13 March 2026, the Food and Drug Supervisory Agency (“BPOM”) issued Regulation of the Food and Drug Supervisory Agency Number 5 of 2026 on the Supervision of the Management of Drugs and Drug Substances in Pharmaceutical Service Facilities and Other Facilities (“BPOM Regulation 5/2026”), which took effect on 6 April 2026. This regulation aims to strengthen supervision of drugs both prior to and during their circulation.

BPOM considers that the public requires maximum protection from exposure to risks arising from drugs and drug substances that do not meet standard requirements of safety, efficacy, and quality. Furthermore, Regulation of the Food and Drug Supervisory Agency Number 24 of 2021 on the Supervision of the Management of Drugs, Drug Substances, Narcotics, Psychotropics, and Pharmaceutical Precursors in Pharmaceutical Service Facilities (“BPOM Regulation 24/2021”) is no longer aligned with legal developments following the enactment of Government Regulation Number 28 of 2024 on Implementing Regulations of Law Number 17 of 2023 on Health. Accordingly, BPOM has expanded the regulatory scope to include facilities beyond pharmacies and hospitals.

 

Comparison

BPOM Regulation 5/2026 revokes and replaces BPOM Regulation 24/2021.

 

Key Provisions

Licensing Legality and Drug Standards

Pursuant to Article 3 and Article 4, businesses operating pharmaceutical service facilities and other facilities must obtain business licensing. Such facilities are only permitted to distribute drugs that have obtained official marketing authorization. These drugs must also comply with standards and/or requirements of safety, efficacy, and quality.

Scope of Management Activities

Article 5 stipulates that pharmaceutical service facilities must carry out management activities covering procurement, receipt, storage, compounding, dispensing, return, destruction, and reporting. Meanwhile, other facilities perform similar management activities, except for compounding. Other facilities are also subject to product limitations, whereby they are only authorized to manage over-the-counter drugs and limited over-the-counter drugs.

Personnel Responsibilities

Articles 7 to 9 regulate the responsibilities of personnel in charge at each facility. The responsible pharmacist must monitor all activities within pharmaceutical service facilities. The responsible pharmacy vocational personnel must control operations in drug stores. Meanwhile, supporting or auxiliary health personnel bear full responsibility in hypermarkets, supermarkets, and minimarkets. These personnel must demonstrate their competence through possession of a practice license or relevant training certification.

Procurement and Receipt Mechanism

Chapters II and IV of the Annex require facilities to procure drugs only from authorized suppliers (such as Pharmaceutical Industries or Pharmaceutical Wholesalers) holding a Good Distribution Practice certificate. Authorized personnel must issue a Purchase Order, in the form of either manual or automated electronic documents that are traceable. During the receipt stage, officers must verify the physical condition of packaging, match documents with goods, and ensure the accuracy of batch numbers and expiration dates. Officers must promptly return drugs to suppliers if defective or non-compliant products are identified.

Storage Standards and Stock Monitoring

Chapters II and IV of the Annex require facilities to store drugs in their original manufacturer packaging, arrange products alphabetically, and maintain separation for products with similar appearance or names (LASA). Managers must install calibrated temperature measuring devices and check storage room temperatures at least twice daily. The responsible person must ensure proper recording of drug movements through stock cards and conduct periodic stock-taking at least once every six months.

Dispensing, Return, and Destruction

Chapters II and IV of the Annex mandate that facilities dispense drugs directly to patients or the public. During dispensing, officers must educate recipients with adequate product information. In the event of a product recall instruction, facilities must respond promptly by halting distribution and returning the product to the original supplier. Where destruction is required, officers must destroy labels and packaging to prevent misuse of residual waste.

Prohibitions for Facilities

Articles 18 to 21 stipulate several prohibited activities for businesses. Facilities are prohibited from trading drugs that fail to meet quality standards. Pharmacy installations in community health centers, clinic pharmacy installations, pharmacies, and other facilities are prohibited from conducting drug manufacturing activities (except for hospital pharmacy installations in accordance with applicable provisions). Pharmaceutical service facilities are prohibited from handling raw materials for narcotics, psychotropics, or pharmaceutical precursors. Furthermore, other facilities are prohibited from handling prescription drugs, narcotics, psychotropics, and drug substances, and are also prohibited from engaging in compounding activities.

 

Sanctions

Article 22 affirms that pharmaceutical service facilities and other facilities that violate the provisions shall be subject to administrative sanctions. These administrative sanctions include:

1. Warning; 
2. Severe warning; and/or 
3. Temporary suspension of activities. 

In addition to these sanctions, the Head of BPOM may also provide a recommendation for revocation of business licensing to the relevant government authority issuing the license if violations are identified based on supervisory findings.

 

Transitional Provisions

Article 24 stipulates that modern retail facilities such as hypermarkets, supermarkets, and minimarkets must complete the adaptation of drug management practices no later than 17 October 2026. Furthermore, drug management activities in the form of distribution by drug stores to hypermarkets, supermarkets, and minimarkets must comply with the provisions of BPOM Regulation 5/2026 no later than 17 October 2026.

 

Closing

BPOM Regulation 5/2026 enhances public protection by expanding the scope of supervision over drug management to include retail facilities such as hypermarkets, supermarkets, and minimarkets. This regulation requires all facilities to obtain proper licensing, to be managed by competent and certified responsible personnel according to their facility classification, and to comply with comprehensive operational standards from procurement through authorized distribution channels to safe waste destruction procedures. The authority of retail facilities is limited to the distribution of over-the-counter and limited over-the-counter drugs, and they are prohibited from conducting compounding or handling prescription drugs and narcotics. To ensure orderly implementation, BPOM imposes administrative sanctions, including recommendations for license revocation for violators, and provides an adaptation period for modern retail facilities until 17 October 2026.