Legal Considerations

Compounding is the preparation, mixing assembling, altering, packaging and labeling of a drug, drug-delivery device, or device in accordance with a licensed practitioner’s prescription, medication order or initiative based on the practitioner/patient/pharmacist/compounder relationship in the course of professional practice.

The USP–NF includes both General Chapters and monographs applicable to compounding, including monographs for compounded preparations. General Chapters contain good compounding practices for sterile and non-sterile preparations and other information helpful to the compounding practitioner. Compounded preparation monographs include formulas (ingredients and quantities), specific directions to correctly compound the particular preparation, packaging and storage information, labeling information, pH (when appropriate), beyond-use dates based on stability studies, and detailed assays (majority of monographs).

Practitioners who compound should understand their responsibility to comply with USP standards. Compounding is largely regulated by the state boards of pharmacy. A number of states have incorporated USP’s compounding General Chapters into their pharmacy laws and regulations, and require conformance with these standards.

While the FDA generally defers to the states to regulate the practice of pharmacy, it does have some oversight over compounding, and may also enforce USP’s compounding standards. The adulteration and misbranding provisions of the Federal Food, Drug and Cosmetic Act (FDCA) state that drugs with USP–NF monographs must comply with the standards for identity, strength, quality, and purity set forth in the monograph. The FDCA does not differentiate between manufactured and compounded drugs. Thus, if a monograph applies to a compounded preparation, the requirements of that monograph must be met.