Removal of Certain Requirements Related to the Prescription Drug Marketing Act; Opportunity for Public Comment; Withdrawal, 6449 [2022-01928]
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Federal Register / Vol. 87, No. 24 / Friday, February 4, 2022 / Proposed Rules
requirements of PDMA, PDA, or this
part, remains responsible for creating
and maintaining all requests, receipts,
forms, reports, and records required
under PDMA, PDA, and this part.
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■ 11. In § 203.37, revise paragraph (e) to
read as follows:
§ 203.37 Investigation and notification
requirements.
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(e) Whom to notify at FDA.
Notifications and reports concerning
samples of human prescription drugs or
biological products that are regulated by
the Center for Drug Evaluation and
Research shall be made via email to
PDMAREPORTS@fda.hhs.gov.
Alternatively, reports and
correspondence concerning such
samples may be made via regular mail
to the Office of Drug Security, Integrity,
and Response, Office of Compliance,
Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Silver Spring, MD
20993–0002, ATTN: PDMA Reports.
Notifications and reports concerning
samples of human prescription
biological products regulated by the
Center for Biologics Evaluation and
Research shall be made to the Food and
Drug Administration, Center for
Biologics Evaluation and Research,
Document Control Center, 10903 New
Hampshire Ave., Bldg. 71, Rm. G112,
Silver Spring, MD 20993–0002.
Subpart E [Removed and Reserved]
12. Remove and reserve subpart E,
consisting of § 203.50.
■
Dated: January 24, 2022.
Janet Woodcock,
Acting Commissioner of Food and Drugs.
[FR Doc. 2022–01927 Filed 2–3–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 203
lotter on DSK11XQN23PROD with PROPOSALS1
[Docket No. FDA–2011–N–0446]
Removal of Certain Requirements
Related to the Prescription Drug
Marketing Act; Opportunity for Public
Comment; Withdrawal
Food and Drug Administration,
Department of Health and Human
Services (HHS).
ACTION: Proposed rule; withdrawal.
AGENCY:
VerDate Sep<11>2014
16:24 Feb 03, 2022
Jkt 256001
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, AaronWeisbuch@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
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 § 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
PO 00000
Frm 00016
Fmt 4702
Sfmt 9990
6449
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 § 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 § 203.50 in its entirety,
rendering the proposed rule published
July 14, 2011, removing § 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 repropose 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
E:\FR\FM\04FEP1.SGM
04FEP1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
