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Tuesday, June 4, 2013

Compounded Drugs

Judith M. Glassgold
Specialist in Health Policy

Compounding has been traditionally defined as a process where a pharmacist or a physician combines, mixes, or alters ingredients to create a medication tailored to the needs of an individual patient. Traditionally compounded drugs (CDs) are made in response to an individual prescription from a licensed health provider in the context of a pharmacist’s and health care professional’s relationship with a specific patient.

Some have suggested that certain activities not traditionally associated with compounding be considered compounding. Such activities include the large-scale production of drugs to ease certain drug shortages, to meet outsourcing needs of hospitals, and to supply physicianadministered drugs. Nontraditional compounding may include (1) the production and shipping of large volumes of drugs across state lines; (2) production of drugs that are copies of FDAapproved commercially available drugs; (3) provision of CD without a prescription for an individual patient to receive a compounded version and outside of a professional relationship; and (4) production of products to third parties, such as hospitals, clinics, physician offices, and home health providers. These activities could be considered more akin to manufacturing than traditional compounding, which is considered part of the traditional practice of pharmacy.

Adverse events involving contaminated compounded drugs have drawn attention to the growing use of nontraditionally compounded drugs in health care delivery. Shortages of sterile generic drugs and hospital outsourcing are cited as causes of increased numbers of CDs produced by nontraditional compounders. Efforts to assess the risks and benefits of CDs on public health and safety are complicated by the lack of publicly available information, including the absence of a federal adverse event reporting requirement and the lack of information about the number of drugs compounded, the types of drugs compounded, and the number of businesses in this market.

Policymakers have raised questions regarding how best to improve the safety of CDs while maintaining patient access to needed medications. Drug compounding has historically been the focus of state governments through their regulation of pharmacies. Recently, questions have arisen regarding the extent to which the federal government can regulate the practice of compounding through the Federal Food, Drug, and Cosmetic Act (FFDCA). Policy discussions include proposals to modify federal oversight of high-risk activities and products, to improve federal and state coordination, and to increase use of existing federal authorities.

This report provides background information on CDs and nontraditional compounding pharmacies relevant to policy discussions. This includes an overview of the 2012 fungal meningitis outbreak; recent recalls of compounded drugs; definitions of traditional compounding and nontraditional compounding; information on the CDs produced and by whom; information on the demand for nontraditional compounding, including the role of shortages of sterile injectable drugs, hospital outsourcing, and patient and provider demand; and information on adverse events involving compounded drugs.

Date of Report: May 23, 2013
Number of Pages: 33
Order Number: R43082
Price: $29.95

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