Pharmacists who handle the preparation are required to comply with the standards and regulations applicable to the types of preparations that are assembled. The FDA oversees the integrity and safety of drugs (called by the FDA active pharmaceutical ingredients or APIs) used in compound preparations. The Drug Enforcement Administration (DEA) oversees all controlled substances used in the manufacture of compound drugs. Controlled substances include narcotics such as hydrocodone, amphetamines and similar medications, as well as medications such as those used for anxiety and sleep disorders. 1. Gudeman J, Jozwiakowski M, Chollet J, et al. Potential risks of composition in pharmacy. Drugs R&D. 2013;13(1):1-8.2. Glass gold J. compound drug.
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Food and Drug Administration. Differences in strength on product labels from conventional preparers and manufacturers can lead to dosing errors. www.fda.gov/drugs/human-drug-compounding/differences-strength-expression-product-labels-compounders-and-conventional-manufacturers-may-lead. Retrieved 27 September 2021.9. National Academies of Sciences, Engineering and Medicine; Ministry of Health and Medicine; Health Sciences Policy Committee; Committee for the Evaluation of Available Scientific Data on the Safety and Efficacy of Ingredients Used in Topical Pain Creams; Jackson LM, Schwinn DA, editor. Compound Topical Pain Creams: Review of selected ingredients for safety, efficacy and application. Washington, DC: National Academies Press; 2020;4. www.ncbi.nlm.nih.gov/books/NBK560345/.
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Accessed September 27, 2021/20. U.S. Food and Drug Administration. FDA Progress Report on Human Drug Preparation: Three years after the Quality and Safety of Drugs Act came into force (January 2017). www.fda.gov/drugs/human-drug-compounding/fdas-human-drug-compounding-progress-report-three-years-after-enactment-drug-quality-and-security. Retrieved 27 September 2021.21. National Association of Boards of Pharmacy. The FDA publishes guidance on adverse event reporting for outsourcing facilities. 14 October 2015.
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