[Federal Register Volume 87, Number 24 (Friday, February 4, 2022)]
[Proposed Rules]
[Page 6449]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-01928]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 203

[Docket No. FDA-2011-N-0446]


Removal of Certain Requirements Related to the Prescription Drug 
Marketing Act; Opportunity for Public Comment; Withdrawal

AGENCY: Food and Drug Administration, Department of Health and Human 
Services (HHS).

ACTION: Proposed rule; withdrawal.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
announcing the withdrawal of the 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. FDA is taking this action because the proposed changes 
are duplicative of another FDA proposed rulemaking, which is also being 
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).

DATES: The proposed rule published July 14, 2011 (76 FR 41434), is 
withdrawn as of February 4, 2022.

ADDRESSES: For access to the docket, go to https://www.regulations.gov 
and insert the docket number found in brackets in the heading of this 
document into the ``Search'' box and follow the prompts, and/or go to 
the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, 
MD 20852.

FOR FURTHER INFORMATION CONTACT: Aaron Weisbuch, Center for Drug 
Evaluation and Research, Office of Compliance, Food and Drug 
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-
796-9362, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Quality and Security Act (DQSA) was enacted on November 
27, 2013. The DQSA contains two titles: Title I, the Compounding 
Quality Act, and Title II, the DSCSA (Pub. L. 113-54). The DSCSA 
amended Chapter V of the Federal Food, Drug, and Cosmetic Act (FD&C 
Act) by adding Subchapter H (Pharmaceutical Distribution Supply Chain), 
sections 581 through 585 (21 U.S.C. 360eee through 360eee-4), and by 
amending section 503(e) of the FD&C Act (21 U.S.C. 353(e)). As amended, 
sections 503(e) and 583 of the FD&C Act require the Secretary to 
establish national prescription drug wholesale distributor licensure 
standards. In addition, section 582 of the FD&C Act establishes 
prescription drug product tracing requirements for wholesale 
distributors and their trading partners.
    On July 14, 2011, FDA proposed to remove Sec.  203.50(a) (21 CFR 
203.50(a)). Before that rulemaking was finalized, the DSCSA was 
enacted. Section 204 of the DSCSA amended section 503(e)(1) through (3) 
of the FD&C Act with additional and different requirements for 
wholesale distributors. The DSCSA also added new requirements for 
wholesale distributors, including phased-in prescription drug tracing 
requirements in section 582(c) of the FD&C Act. Because of the changes 
to requirements for wholesale distributors under the DSCSA, the 
Agency's proposed rule published on July 14, 2011, to remove Sec.  
203.50(a), was never finalized.
    In its proposed rulemaking entitled ``Certain Requirements 
Regarding Prescription Drug Marketing,'' published elsewhere in this 
issue of the Federal Register, FDA will propose a rule that will seek 
to amend part 203 (21 CFR part 203) to remove provisions no longer in 
effect and incorporate conforming changes following enactment of the 
DSCSA. In the proposed rulemaking, the Agency will clarify provisions 
to avoid potential confusion with the new standards for wholesale 
distribution established by the DSCSA. The amendments to part 203 in 
the proposed rule will include the removal of Sec.  203.50 in its 
entirety, rendering the proposed rule published July 14, 2011, removing 
Sec.  203.50(a), obsolete.

II. Withdrawal of the Proposed Rule

    As result of these efforts, FDA is withdrawing the proposed rule 
``Removal of Certain Requirements Related to the Prescription Drug 
Marketing Act; Opportunity for Public Comment,'' published in the 
Federal Register of July 14, 2011.
    The withdrawal of this proposed rule does not preclude the Agency 
from reinstituting rulemaking concerning the issues addressed in the 
proposal. Should we decide to undertake such rulemakings in the future, 
we will re-propose the actions and provide new opportunities for 
comment. Furthermore, this proposed rule is only intended to address 
the withdrawal of the proposed rule on ``Removal of Certain 
Requirements Related to the Prescription Drug Marketing Act; 
Opportunity for Public Comment,'' published in the Federal Register of 
July 14, 2011, and not any other pending proposals that the Agency has 
issued or is considering. If you need additional information about the 
subject matter of the withdrawn proposed rule, visit the Agency's 
website at https://www.fda.gov for any current information on the 
matter.

    Dated: January 24, 2022.
Janet Woodcock,
Acting Commissioner of Food and Drugs.
[FR Doc. 2022-01928 Filed 2-3-22; 8:45 am]
BILLING CODE 4164-01-P


