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Amendments to the Regulation Regarding the List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness (Final Rule) Regulatory Impact Analysis

Amendments to the Regulation Regarding the List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness (Final Rule) Regulatory Impact Analysis

The Food and Drug Administration is amending its regulations to revise the list of drug products that have been withdrawn or removed from the market because such drug products or components of such drug products have been found to be unsafe or not effective. Drug products appearing on this list may not be compounded under the exemptions provided by sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act. Specifically, the final rule adds two entries to this list of drug products. The Agency is not aware of routine compounding of drug products containing bromocriptine mesylate for prevention of physiological lactation or intravenous drug products containing greater than a 16 mg single dose of ondansetron hydrochloride. Therefore, we do not estimate any compliance costs or loss of sales as a result of the prohibition against compounding these drugs for human use.

Federal Register: 83 FR 63569, December 11, 2018

Docket: FDA-2016-N-2462