Proposed Rule2022-01928
Removal of Certain Requirements Related to the Prescription Drug Marketing Act; Opportunity for Public Comment; Withdrawal
Primary source
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Published
February 4, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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).
Full Text
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<title>Federal Register, Volume 87 Issue 24 (Friday, February 4, 2022)</title>
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[Federal Register Volume 87, Number 24 (Friday, February 4, 2022)]
[Proposed Rules]
[Page 6449]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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withdrawn as of February 4, 2022.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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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, <a href="/cdn-cgi/l/email-protection#f3b292819c9da4969a809186909bb3959792dd9b9b80dd949c85"><span class="__cf_email__" data-cfemail="236242514c4d74464a504156404b634547420d4b4b500d444c55">[email protected]</span></a>.
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 <a href="https://www.fda.gov">https://www.fda.gov</a> 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
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