Zsalzsabella Putri Moudzie (2019) Peranan Badan Pengawas Obat Dan Makanan Dalam Perlindungan Konsumen Terhadap Obat Racikan Apotek Tanpa Resep Dokter. Skripsi thesis, UNIVERSITAS AIRLANGGA.

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Abstract

This thesis is entitled "THE ROLE OF DRUG AND FOOD SUPERVISORY AGENCIES IN CONSUMER PROTECTION OF DRUGS AND DRUGS FOR MEDICINE PROTECTION WITHOUT RECIPES" which is a normative juridical study using a statutory approach (statue approach) and conceptual approach. The legal materials used consist of primary, secondary and tertiary legal materials. Primary legal material in the form of laws and regulations, minutes of decisions or legislation that are relevant to legal issues. Secondary legal materials in the form of legal books, scientific papers and journals, both print and electronic. Tertiary legal material in the form of interviews. The legal materials were analyzed to answer the problem formulation, namely the Legality of Drugs without Drugs Prescription and the Authority of BPOM and the Liability for Drug Abuse of Drugs without Pharmacy Prescription. The rise of pharmaceutical business actors, in this case, is a pharmacy, in selling concoction drugs without a doctor's prescription in several regions in Indonesia causing losses in consumers. Consumer protection is regulated in Act Number 8 of 1999 concerning Consumer Protection, then consumer rights in the health sector are recognized by Act Number 36 of 2009 concerning Health. Both of these regulations require that at least the consumer is guaranteed his right to use the drug, including comprehensive information related to the drug obtained at the Pharmacy. This is not heeded by a number of pharmacies in Indonesia who pack concoction drugs in plastic packages and do not meet the information standards that must be listed. BPOM as an institution that is given authority in law enforcement for drug distribution that is not in accordance with standards can take product withdrawal as well as administrative sanctions against business actors. In addition, the Consumer Protection Act provides a platform for consumers who are disadvantaged to be able to file liability through the Consumer Dispute Resolution Agency (BPSK). It is against the law to act in selling pharmacies without prescription. Pharmaceutical service standards in pharmacies need to pay attention to the provisions of relevant laws and regulations, as well as the need for efforts from the government to maximize the duties of institutions related to violations of pharmacies selling concoction drugs without a doctor's prescription.

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