Provisions on Recalls and Destruction of Below Standard Drugs Updated

The National Agency for Drug and Food Control (Badan Pengawas Obat dan Makanan – “BPOM”) has updated provisions on the recall and destruction of drugs that do not meet safety, efficacy, quality and labeling standards and/or requirements (collectively referred to as “Below Standard Drugs”) through the issuance of Regulation No. 14 0f 2022 (“Regulation 14/2022”). Said matters were previously addressed under Regulation of the BPOM No. 14 of 2019 (“Regulation 14/2019”). However, as Regulation 14/2019 is no longer considered in line with legal, scientific and technological developments, it has now been repealed and replaced.[1]