Drug compounding is often regarded as the process of combining, mixing, or altering ingredients to create a medication tailored to the needs of an individual patient.
What Physicians Should Know About Compounded Drugs
Julie Dohm, PhD, JD, Of Counsel at Covington & Burling. Between 2016 and 2019, Julie served as the lead on compounding for the U.S. Food and Drug Administration (FDA).
In certain situations, compounding can serve an important patient need. For example, when a patient who has an allergy to a certain ingredient dye, or an elderly patient or child who cannot swallow a tablet or capsule. However, some compounders engage in activities that can put patients at risk and/or undermine the drug approval process. For example, FDA has observed that some compounders have made false and misleading statements suggesting the drugs had met the standard for FDA approval.
Compounded drugs are not FDA-approved. They can serve an important medical need for patients, but they do not have the same safety, quality, and effectiveness assurances as approved drugs. Unnecessary use of compounded drugs can expose patients to potentially serious health risks. Because compounded drugs are not FDA-approved, FDA does not verify their safety, effectiveness, or quality before they are marketed. In addition, poor compounding practices can result in serious drug quality problems, such as contamination or a drug that contains too much active ingredient.
If you have any questions on compounding, email FDA’s compounding team at compounding@fda.hhs.gov.
FDA Resources
Compounding Quality Center of Excellence FDA’s efforts to improve the quality of compounded drugs, primarily those made at outsourcing facilities.
Compounding Laws and Policies Federal law and FDA policies that apply to compounding and other activities compounders undertake.
Compounding Oversight and Compliance Actions Links to compounding inspections, recalls, and other actions, as well as descriptions of some of the documents and actions involved in FDA oversight of compounding.
Information for Outsourcing Facilities Information for outsourcing facilities, as well as a list of currently registered outsourcing facilities.
Bulk Drug Substances Used in Compounding. Information on using bulk drug substances.
Information for Consumers and Health Care Professionals Resources for consumers who use compounded medicines and health care professionals who prescribe compounded medicine.
Sources
U.S. Food and Drug Administration: Compounding and the FDA: Questions and Answers. https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers Accessed September 27, 2021.
The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use. https://www.ncbi.nlm.nih.gov/books/NBK562881/ Accessed September 27, 2021.
Compounding Vs. FDA Approved Medications
Salvatore Dileo, RPh, Director of Pharmacy, Westmed Medical Group in New York, discusses the differences between compounded medications versus FDA-approved drugs.
Julie Dohm, PhD, JD: Between 2016 and 2019, Julie served as the lead on compounding for the U.S. Food and Drug Administration (FDA).
