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August 20, 2024 Drug compounding is the tailoring of ingredients for the needs of an individual patient. It is the “cocktailing” of two or more individual approved drugs when a single drug is not sufficient for treatment.
The FDA position on compounding is divided. If the producer is an outsourced provider, the facilities are subject to GMP compliance requirements, as specified in section 503B in the FD &C Act. The Section 503A producers are licensed pharmacists or physicians and are exempt from these requirements.
A 503B compounded drug is not subject to the FDA required safety and efficacy studies, as in the New Drug Application (NDA) process. While the potential combination might provide extended medical benefits, the quality of the drug item itself can vary, and even be hazardous due to lack of stringent production practices.
The FDA is clearly seeking to tighten up the regulation for both 503A and 530B compounding. Some recent proposed changes include listing certain drugs that cannot be used in the compounding process.
There are several data operations that are key to safe, reliable 503B compounding. InstantGMP CFR-based software provides inventory management (and more) for materials at several important 503B compounding process steps:
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All components and finished good are bi-directionally traceable.
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Quantities of materials added to a product are rigorously controlled within a min-max range
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Work in process potency can be measured and recorded at any step in the Electronic Batch Record process.
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All materials and finished goods must meet applicable specifications to be approved for use.
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The inventory system monitors critical ‘use by’ and ‘retest’ dates in real time for all material receipts.
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The Vendor/Customer/Partner Management operation automates qualified supplier agreements that can ensure trusted material quality.
If you would like to learn more about how our products can support 503B compounding, contact us at www.instantgmp.com