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Let's continue our discussion of the DQSA and the specific sections of 503A of the FD&C Act requiring rulemaking or other action by FDA.
1. Withdrawn or Removed List
Already covered
2. Bulk Drug Substances List
Already covered.
3. Memorandum of Understanding Between FDA and the States
Already covered.
4. "Demonstrable Difficulties" for Compounding
Presented general information so far. This week, we will look at some more explanatory discussion on how the FDA will determine what is difficult to compound.
The following comes from PCAC's discussion on July 13 and 14, 2000 on how drug products and categories of drug products will be determined to be "difficult to compound."
To facilitate FDA's review, nominations may include responses to the following six questions, which are related to the criteria FDA presented to the PCAC for evaluating whether drug products and categories of drug products are difficult to compound under sections 503A and 503B of the FD&C Act:
1. Does the drug product or category of drug products have a complex formulation that presents a demonstrable difficulty for compounding that is reasonably likely to lead to an adverse effect on the safety or effectiveness of the drug product?
2. Does the drug product or category of drug products have a complex drug delivery mechanism that presents a demonstrable difficulty for compounding that is reasonably likely to lead to an adverse effect on the safety or effectiveness of the drug product?
3. Does the drug product or category of drug products involve a complex dosage form that presents a demonstrable difficulty for compounding that is reasonably likely to lead to an adverse effect on the safety or effectiveness of the drug product?
4. Does the drug product or category of drug products involve complexities in achieving and/or assessing bioavailability that present a demonstrable difficulty for compounding that is reasonably likely to lead to an adverse effect on the safety or effectiveness of the drug product?
5. Does compounding the drug product or category of drug products involve a complex compounding process that presents a demonstrable difficulty for compounding that is reasonably likely to lead to an adverse effect on the safety or effectiveness of the drug product?
6. Does compounding the drug product or category of drug products necessitate complex physicochemical or analytical testing that presents a demonstrable difficulty for compounding that is reasonably likely to lead to an adverse effect on the safety or effectiveness of the drug product?
Editor's Note: In a following issue, we will look at the current status of this aspect of the DQSA.
Federal Register: Drug Products That Present Demonstrable Difficulties for Compounding Under the Federal Food, Drug, and Cosmetic Act; Establishment of a Public Docket
July 24, 2017.
Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
IJPC
Remington: The Science and Practice of Pharmacy Twenty-second edition
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