Feb 4 -- The Food and Drug Administration (FDA) is proposing two rules to implement the Drug Supply Chain Security Act with regard to wholesale distributors:
1) FDA is proposing to amend part 203 (21 CFR part 203) to reflect changes to affected provisions of the FD&C Act following enactment of the DSCSA, Title II of the DQSA (Pub. L. 113-54). In this proposed rulemaking, we are proposing to amend certain provisions of part 203 to avoid potential confusion with the new standards and requirements for wholesale distributors applicable under the FD&C Act (as amended by the DSCSA), and to make certain related, conforming changes. Public comments on the proposed rule are due by April 5, 2022.
The proposed rule would: (1) Modify the “scope” and “purpose” sections of the regulations in part 203 to eliminate references to wholesale distribution, (2) delete Subpart E—Wholesale Distribution in its entirety, (3) delete from § 203.3 the definitions for terms that only appeared in subpart E, and (4) modify other provisions of part 203 to eliminate references to wholesale distribution to conform to the changes described above.
FR notice inviting comment:
https://www.federalregister.gov/documents/2022/02/04/2022-01927/certain-requirements-regarding-prescription-drug-marketing
Related FR notice withdrawing proposed rule “Removal of Certain Requirements Related to the Prescription Drug Marketing Act; Opportunity for Public Comment,” published in the Federal Register on July 14, 2011, because the proposed changes are duplicative of another FDA proposed rulemaking, published in this issue of the Federal Register, that is intended to conform with newly established definitions and requirements set out by the Drug Supply Chain Security Act of 2013 (DSCSA).
https://www.federalregister.gov/documents/2022/02/04/2022-01928/removal-of-certain-requirements-related-to-the-prescription-drug-marketing-act-opportunity-for
2) The Food and Drug Administration (FDA, the Agency, or we) is proposing national standards for the licensing of prescription drug wholesale distributors (“wholesale distributors” or “wholesale drug distributors”) and third-party logistics providers (“3PLs”), as directed under the Drug Supply Chain Security Act (DSCSA) (Title II of the Drug Quality and Security Act). Pursuant to the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the DSCSA, the proposed rule would establish standards for all State and Federal licenses issued. Public comments on the proposed rule are due by June 6, 2022.
This proposed regulation, when finalized, will establish the national standards for the licensure of wholesale drug distributors and 3PLs required under sections 583 and 584 of the FD&C Act, as amended by the DSCSA. As required by statute, the standards, terms and conditions for licensure established by this regulation will apply to both Federal and State licenses (503(e)(1)(B), 583(b), and 584(a)(1)(A) of the FD&C Act).
The requirements for state licensing of wholesale distributors are currently established under 21 CFR part 205, and FDA is now proposing the withdrawal of that regulation and for part 205 to be replaced with this proposed rule. Where a state from which a drug is being distributed has not established a licensing program in accordance with the regulation, the DSCSA establishes FDA as the licensing authority for wholesale distributor and 3PL licenses (sections 503(e)(1)(A)(i)(II) and 584(a)(1)(B) of the FD&C Act). When finalized, the national standards set forth in the proposed rule will provide greater assurance that these supply chain participants are sufficiently vetted and qualified to distribute products, further strengthening the supply chain and the safety of prescription drugs provided to American consumers.
When finalized, this proposed rule will also set forth the standards applicable to, and the requirements for approval of, third-party organizations involved in the licensure and inspection process (“approved organizations” or “AOs”). Sections 583(c) and 584(d)(2)(A) of the FD&C Act provide, respectively, that FDA may approve “third-party accreditation” or inspection services or programs to conduct inspections of facilities used by wholesale distributors seeking licensure and to review the qualifications of 3PLs for licensure. This proposed rule will also address the standards and requirements for approving such third-party accreditation or inspection services or programs.
Overall, this proposed rule is designed to ensure that the supply chain remains secure and that those prescription drugs subject to the DSCSA that are moving through the supply chain are properly stored, handled, and transported. These measures are intended to help protect American consumers from drugs that may be counterfeit, stolen, contaminated, or otherwise harmful.
FR notice inviting public comment:
https://www.federalregister.gov/documents/2022/02/04/2022-01929/national-standards-for-the-licensure-of-wholesale-drug-distributors-and-third-party-logistics
FDA submission to OMB for sections 583, 584 data collections:
https://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=202202-0910-012 Click IC List for data collection instruments, View Supporting Statement for technical documentation.
Also, FDA is announcing the availability of a final guidance for industry entitled “Drug Product Tracing: The Effect of Section 585 of the FD&C Act—Questions and Answers.” FDA is issuing this guidance to assist industry and State and local governments in understanding the effects of the uniform national policy set forth in the FD&C Act that was added by the DSCSA. This guidance is intended to help industry and States understand the law as it is currently in effect and clarify its effect on State product tracing. This guidance finalizes the draft guidance entitled “The Effect of Uniform National Policy on Drug Product Tracing and Wholesale Drug Distributor and Third-Party Logistics Provider Standards: Questions and Answers” issued on October 8, 2014.
May 24 -- The comment period for this proposed rule is extended to September 6, 2022.
https://www.federalregister.gov/d/2022-11116