Legal Considerations

Compounding means 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 preparation, mixing, assembling, altering, packaging, and labeling of a drug, drug-delivery device, or device in accordance with a licensed pratictioner's prescription, medication order,or initiative based on the practitioner/patient/pharmacist/compounder relations in the course of professional practice. Compounding includes the following:

• Preparation of drug dosage forms for both human and animal patients.
• Preparation of drugs or devices in anticipation of prescription drug orders based on routine, regularly observed prescribing patterns
• Preparation of drugs or devices for the purpose of, or as an incident to, research (clinical or academic), teaching, or chemical analysis
• Preparation of drugs and devices for prescriber's office use where permitted by federal and state law

USP provides both general chapters and monographs for compounded preparations. 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). Standards in USP–NF for compounded preparations may be enforced by both the states (as pharmacy practice/compounding is traditionally regulated by state boards of pharmacy), and FDA (as compounded preparations remain subject to the adulteration and misbranding provisions of the FD&C Act which require conformance to USP–NF standards).

Practitioners who compound should understand their responsibility to comply with standards in the USP. Simply said, compounded preparations must meet official USP–NF standards, including ingredient standards and the "recipe" for the preparation. It is widely understood that key requirements of the Federal Food, Drug, and Cosmetic Act (FFDCA) apply equally to drugs that are compounded and those that are manufactured. For compounding practitioners, that means drugs sold in the United States that are recognized in official compendia (including USP–NF) must adhere to those standards for identity, quality, purity, and strength, a well as packaging and labeling.

Thus, while the FDA generally defers to the states to regulate the practice of health professions, it takes a keen interest in the quality and safety of the compounded preparations that reach patients. The FDA will act in concert with the states in investigating allegations of poor quality compounded drugs, but it has also demonstrated a willingness under the FFDCA to act on its own initiative. If a state is unwilling or unable to join the Agency's efforts, the FDA may act unilaterally to protect the public health from compounded drugs that pose unreasonable risks.