Issues of public health and safety of CDs are tied to the regulation and oversight of CDs. This report includes brief information on federal, state, and professional efforts to increase the safety of CDs. Traditionally CDs are made in response to an individual prescription from a licensed health provider in the context of a pharmacist's and health care provider's professional relationship with a specific patient. Shortages of sterile generic drugs and hospital outsourcing are cited as causes of increased the reliance of health care providers on CDs. 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 physician-administered drugs. Non-traditional compounding may include (1) the production and shipping of large volume of drugs across state lines; (2) production of drugs that are copies of FDA-approved commercially available drugs; (3) production of drugs outside of a personal relationship with a patient and without a prescription for an individual patient to receive a compounded version; and (4) providing products to third parties, such as hospitals, clinics, physician offices, and home health providers. These activities may be considered more akin to manufacturing than traditional compounding, which is considered part of the traditional practice of pharmacy. The 2012 fungal meningitis outbreak led to greater scrutiny by federal and state authorities of sterile CDs. Traditional Compounding

Traditional compounding is 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" in response to a prescription from a health care provider. The lack of information on the current scope of compounding presents challenges for public health authorities and policy makers. Some non-traditional compounders have large numbers of customers. Existing Regulatory Oversight

Drug compounding has historically been the focus of state governments through their regulation of pharmacies. Recently questions have arisen regarding the extent the federal government can regulate the practice of compounding through the FFDCA. Shortages of CDs

Recalls of products from compounding pharmacies may also exacerbate drug shortages. Adverse Event Reporting and Labeling

There is a lack of publically available information on the number and types of adverse events involving compounded drugs, as there is no requirement that compounders report adverse events to federal authorities, and state requirements vary. Due to the complexity of the supply chain and the growth of non-traditional compounding, patients and providers may not realize that a drug has been compounded. The Federal Role in Oversight

Policymakers have raised questions regarding how best to improve the safety of CDs while maintaining patient access to needed medications, including the need for new legislation and increased accountability.
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 physician-administered drugs. Non-traditional compounding may include (1) the production and shipping of large volume of drugs across state lines; (2) production of drugs that are copies of FDA-approved 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 non-traditionally 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 non-traditional 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 clarify 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 non-traditional compounding pharmacies relevant to policy discussions. This includes an overview of the 2012 fungal meningitis outbreak, recent safety alerts and recalls of compounded drugs, definitions of traditional compounding and non-traditional compounding, information on the CDs produced and by whom, information on the demand for non-traditional compounding, including the role of shortages of sterile injectable drugs, hospital out-sourcing, and patient and provider demand, and information on adverse events involving compounded drugs.