Importance of Testing Raw Materials: Drug Components
Drug components differ in purity, specifications and quality. According to FDA draft guidance, it's important for compounding pharmacies and outsourcing facilities to verify drug components purchased from suppliers.
Pharmacists verify drug components by:
- reviewing the supplier's certificates of analysis (COA)s;
- establishing reliability of the supplier's analyses through vendor qualification; and,
- testing drug components before use in compounding.
The FDA draft guidance for 503B outsourcing facilities states that "in lieu of testing each shipment of each ingredient, a COA can be accepted from the supplier and evaluated to determine whether a lot can be used, provided that the following conditions are met":
- Pharmacists confirm the supplier's test results, no less frequently than annually for active ingredients and every two years for other components, by performing full compendial testing using the applicable USP or NF monographs and/or supplier's in-house methods.
- Pharmacists conduct at least one identity test to confirm the component purchased from the supplier.
Pharmacists are responsible for compounding preparations of acceptable identity (active ingredient and excipient), strength (concentration of the active ingredient), quality (safe, effective and acceptable to the patient), and purity (not contaminated with potentially harmful substances). The following drug component specifications are considered critical to ensure the quality of a finished drug product: identity, strength, purity, particle size, sterility, and endotoxin. Nonsterile components from suppliers must include microbial and endotoxin testing when used in the production of sterile drug products.
If a drug component is stored for a long period of time or has had exposure to air, heat or other conditions that might adversely affect the drug component, the ingredients need to be re-tested for identity, strength, quality, and purity.
If a drug component has an assigned expiration date, the pharmacist cannot extend the supplier's expiration date by means of re-testing. If a drug component is labeled with a retest date, the material can be re-tested in compliance with specifications to ensure that it is still suitable for use.
- Allen, LA "The Art, Science, and Technology of Pharmaceutical Compounding"
- Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug and Cosmetic Act
- Guidance for Industry Current Good Manufacturing Practice - Interim Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act
- USP <795>
- USP <797>