The Practice of Compounding, Associated Compounding Regulations, and the Impact on Dermatologists. 2018

James Quertermous, and Seemal Desai, and Julie Harper, and Mark Lebwohl, and Abel Torres, and Leon H Kircik

Medication compounding gained national attention in the fall of 2012 after contaminated compounded medications produced in the New England Compounding Center infected 800 people with fungal meningitis and led to several fatalities. This prompted Congress to pass regulations on compounding through the Drug Quality and Security Act (DQSA) in 2013. The act increased oversight of patient-specific drug compounding taking place in compounding pharmacies, created 503(b) outsourcing facilities to obtain compounded drugs, and added regulations for obtaining compounded drugs from traditional 503(a) pharmacies. These regulations also had a broader overall impact by triggering federal and state-specific policies, which have ultimately limited a physician's ability to perform low-risk, in-office compounding. This article provides an overview of the different types of compounding restrictions, reviews the current federal and state regulations and/or guidelines, discusses how newly proposed policies may affect the practice of dermatology, and presents an algorithm on how the practicing dermatologist should approach compounding. J Drugs Dermatol. 2018;17(7 Suppl):s17-22.

UI MeSH Term Description Entries
D010593 Pharmaceutical Services Total pharmaceutical services provided by qualified PHARMACISTS. In addition to the preparation and distribution of medical products, they may include consultative services provided to agencies and institutions which do not have a qualified pharmacist. Pharmaceutic Services,Pharmaceutical Care,Pharmacy Services,Services, Pharmaceutic,Services, Pharmaceutical,Services, Pharmacy,Care, Pharmaceutical,Pharmaceutic Service,Pharmaceutical Service,Pharmacy Service,Service, Pharmaceutic,Service, Pharmaceutical,Service, Pharmacy
D011786 Quality Control A system for verifying and maintaining a desired level of quality in a product or process by careful planning, use of proper equipment, continued inspection, and corrective action as required. (Random House Unabridged Dictionary, 2d ed) Control, Quality,Controls, Quality,Quality Controls
D003879 Dermatologic Agents Drugs used to treat or prevent skin disorders or for the routine care of skin. Agent, Dermatologic,Agent, Dermatological,Agents, Dermatologic,Dermatologic Agent,Dermatological Agents,Agents, Dermatological,Dermatological Agent
D004339 Drug Compounding The preparation, mixing, and assembly of a drug. (From Remington, The Science and Practice of Pharmacy, 19th ed, p1814). Drug Formulation,Drug Preparation,Drug Microencapsulation,Pharmaceutical Formulation,Compounding, Drug,Formulation, Drug,Formulation, Pharmaceutical,Microencapsulation, Drug,Preparation, Drug
D004340 Drug Contamination The presence of organisms, or any foreign material that makes a drug preparation impure. Drug Adulteration,Drug Contamination, Chemical,Drug Contamination, Microbial,Drug Contamination, Physical,Drug Impurity,Adulteration, Drug,Chemical Drug Contamination,Chemical Drug Contaminations,Contamination, Chemical Drug,Contamination, Drug,Contamination, Microbial Drug,Contamination, Physical Drug,Contaminations, Chemical Drug,Contaminations, Microbial Drug,Contaminations, Physical Drug,Drug Adulterations,Drug Contaminations,Drug Contaminations, Chemical,Drug Contaminations, Microbial,Drug Contaminations, Physical,Drug Impurities,Impurity, Drug,Microbial Drug Contamination,Microbial Drug Contaminations,Physical Drug Contamination,Physical Drug Contaminations
D005791 Patient Care The services rendered by members of the health profession and non-professionals under their supervision. Informal care,Care, Patient,Informal cares,care, Informal,cares, Informal
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000072085 Dermatologists Physicians who specialize in treating disorders of the skin. Dermatologist
D012871 Skin Diseases Diseases involving the DERMIS or EPIDERMIS. Dermatoses,Skin and Subcutaneous Tissue Disorders,Dermatosis,Skin Disease
D014481 United States A country in NORTH AMERICA between CANADA and MEXICO.

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