| FDA Highlights Concerns with Compounding of Drug Products by Medical Offices and Clinics Under Insanitary Conditions | | | Human drug compounding is generally a practice in which ingredients of a drug are combined, mixed, or altered to create a medication tailored to the medical needs of an individual patient. Section 503A of the Federal Food, Drug and Cosmetic Act (FD&C Act) describes the conditions under which compounded human drug products are exempt from the following three sections of the FD&C Act: - Section 505 concerning approval prior to marketing
- Section 501(a)(2)(B) concerning current good manufacturing practice (CGMP) requirements
- Section 502(f)(1) concerning labeling with adequate directions for use
One of the conditions to qualify for these exemptions is that the drug is compounded by a licensed pharmacist in a state-licensed pharmacy or federal facility, or by a licensed physician, based on the receipt of a valid patient-specific prescription. Compounded drugs that meet the conditions of section 503A are still subject to section 501(a)(2)(A) of the FD&C Act which states a drug is considered adulterated if it has been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health. FDA has become increasingly aware of drug products compounded at medical offices and clinics that were prepared under insanitary conditions. FDA has also become aware of business models, such as intravenous (IV) hydration clinics, medical spas, and mobile IV infusion services, that are compounding drugs that may not meet the conditions of section 503A of the FD&C Act or comply with state regulations. Contaminated, or otherwise poor quality, compounded drug products can lead to serious patient illnesses, including death. | | | |
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