The practice of compounding is regulated by state boards of pharmacy. Community and hospital compounding pharmacists are allowed exemptions to the Federal Food, Drug, and Cosmetic Act of 1938 if they comply with the regulations outlined in Section 503A. All pharmacists and pharmacies engaged in compounding are subject to oversight by both federal and state authorities.   Pharmacists engaged in compounding are expected to follow applicable standards and regulations for the types of preparations that are compounded. FDA has oversight for the integrity and safety of the drugs (called Active Pharmaceutical Ingredients, or APIs, by FDA) used in compounded preparations.  The Drug Enforcement Administration (DEA) has oversight for any controlled substances used in the preparation of compounded medications. Controlled substances include narcotics such as hydrocodone, amphetamines, and similar drugs, and drugs such as those used for anxiety and sleep disorders.   In addition, the United States Pharmacopeial (USP) Convention issues standards that apply to compounding. This private, nonprofit organization defines the chemical purity of drugs and also issues practice standards. USP develops standards for the identity, quality, strength, and purity of medicines, dietary supplements, and food ingredients that may be used in compounding preparations. These standards in particular are relevant to compounding pharmacists.   All licensed pharmacists learn during their training and education to perform basic compounding. In addition, most pharmacies have some compounding tools, such as a mortar and pestle for grinding materials, graduated cylinders for measuring liquids, balances for weighing solids, spatulas for mixing materials, and ointment slabs on which to work. With such tools and through applying their knowledge, all pharmacists routinely prepare nonsterile compounded preparations when requested by prescribers.   Of the approximately 56,000 community-based pharmacies in the United States, about 7,500 pharmacies specialize in compounding services. This means the pharmacists in those facilities spend most or all of their time compounding special preparations for patients. Preparations made in these pharmacies are more likely to include both sterile and nonsterile dosage forms. Compounding also takes place in hospital pharmacies and at other health care facilities.   USP General Chapter <797> is a national standard for the process, testing, and verification of any compounded sterile preparations. It provides guidance on preventing microbial contamination and other variances in compounded sterile preparations, regardless of setting (e.g., hospitals, community pharmacies) or who is performing the compounding (pharmacists, nurses, pharmacy technicians, or others).   USP General Chapter <795> provides similar guidance for nonsterile preparations that are compounded in health care settings. It describes categories of compounding (simple, moderate, complex), defines concepts such as beyond-use date and stability, and provides criteria for compounding pharmacists to follow in preparing various drug preparations.   USP General Chapter <800> is a new standard developed by USP that establishes practice and quality standards of hazardous drugs to minimize the exposure to hazardous drugs within health care settings. This standard aims to promote worker safety (pharmacists, pharmacy technicians, veterinarians, veterinary technicians, and many others), patient safety, and environmental protection. This standard was published on February 1, 2016, but will not be officially implemented until July 1, 2018. The current list of hazardous drugs is available from the National Institute for Occupational Safety and Health (NIOSH).   Compliance with these and other USP guidelines is considered the minimum standard of practice in pharmacy.   Pharmacy Compounding Accreditation Pharmacy Compounding Accreditation is a service of the Accreditation Council for Health Care (ACHC) that assesses the nonsterile and sterile pharmacy compounding process as defined by a specific set of standards that concentrate on the quality and consistency of medications produced.