[Federal Register Volume 79, Number 8 (Monday, January 13, 2014)]
[Rules and Regulations]
[Pages 2093-2094]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-00322]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 14

[Docket No. FDA-2013-N-1687]


Advisory Committee; Pharmacy Compounding Advisory Committee

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending its 
regulations to update information regarding the Pharmacy Compounding 
Advisory Committee in FDA's Center for Drug Evaluation and Research in 
the Agency's list of standing advisory committees. This updated 
information regarding the Committee includes changes to its charter to 
reflect the recent enactment of the Drug Quality and Security Act.

DATES: This rule is effective January 13, 2014.

FOR FURTHER INFORMATION CONTACT: Jayne E. Peterson, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-
796-9001, FAX 301-847-8533, email: PCAC@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: FDA announced the original establishment of 
the Pharmacy Compounding Advisory Committee (the Committee) and amended 
the regulations at Sec.  14.100 (21 CFR 14.100) to add the Committee to 
the Agency's standing list of advisory committees in the Federal 
Register of March 10, 1998 (63 FR 11596). The Committee was established 
under authorities that included the Federal Advisory Committee Act 
(Pub. L. 92-463), section 1004 of the Federal Food, Drug, and Cosmetic 
Act (the FD&C Act) (21 U.S.C. 394), and section 503A of the FD&C Act 
(21 U.S.C. 353a), as enacted as part of the Food and Drug 
Administration Modernization Act of 1997 (FDAMA) (Pub. L. 105-115), 
which exempted drugs compounded by pharmacies from the FD&C Act's new 
drug approval, adequate directions for use, and good manufacturing 
practice requirements if specified conditions, including two 
restrictions on commercial speech, were met. Section 503A of the FD&C 
Act as added by FDAMA also required the Agency to convene and consult 
with an advisory committee on compounding before issuing specified 
regulations.
    In 2002, FDA terminated the Committee in response to the Supreme 
Court's decision in Thompson, et al. v. Western States Medical Center 
Pharmacy, et al. (535 U.S. 357 (2002)). That decision affirmed a 
decision of the U.S. Court of Appeals for the Ninth Circuit that held 
the speech related provisions of section 503A of the FD&C Act, as added 
by FDAMA, were unconstitutional. The Supreme Court held that the speech 
related restrictions in section 503A of the FD&C Act violated the First 
Amendment. The Ninth Circuit had also concluded that the 
unconstitutional speech restriction could not be severed from the other 
provisions of section 503A of the FD&C Act. The Supreme Court did not 
reach

[[Page 2094]]

this issue. Therefore, the Ninth Circuit's opinion invalidating section 
503A of the FD&C Act in its entirety remained intact. FDA stated its 
view at the time, which was that the underlying authority in section 
503A of the FD&C Act to establish the Pharmacy Compounding Advisory 
Committee was invalidated and without a statutory basis for the 
Committee, the Agency terminated the Committee (67 FR 70227, November 
21, 2002).
    Subsequently, in 2008, the U.S. Court of Appeals for the Fifth 
Circuit decided Medical Center Pharmacy v. Mukasey (536 F.3d 383 (5th 
Cir. 2008)), in which that court disagreed with the Ninth Circuit's 
holding regarding the severability of section 503A of the FD&C Act as 
added by FDAMA. The Fifth Circuit found the unconstitutional provisions 
of section 503A of the FD&C Act to be severable and that the other 
provisions could remain in effect. Based on this decision, FDA 
reestablished the Pharmacy Compounding Advisory Committee in 2012.
    On November 27, 2013, the President signed into law the Drug 
Quality and Security Act (Pub. L. 113-54). This law removed the 
unconstitutional provisions from section 503A and added a new section 
503B to the FD&C Act (21 U.S.C. 353b) that also requires FDA to consult 
with a Pharmacy Compounding Advisory Committee before issuing certain 
regulations pertaining to outsourcing facilities. As a result, FDA has 
amended the charter of the Pharmacy Compounding Advisory Committee to 
reflect the relevant statutory changes.
    Under the amended charter, the Committee provides advice on 
scientific, technical, and medical issues concerning drug compounding 
under sections 503A and 503B of the FD&C Act and, as required, any 
other product for which FDA has regulatory responsibility, and makes 
appropriate recommendations to the Commissioner of Food and Drugs (the 
Commissioner).
    The Committee will be composed of a core of 12 voting members 
including the Chair. Members and the Chair are selected by the 
Commissioner or designee from among authorities knowledgeable in the 
fields of pharmaceutical compounding, pharmaceutical manufacturing, 
pharmacy, medicine, and related specialties. Membership also includes 
representatives from the National Association of Boards of Pharmacy and 
the United States Pharmacopoeia, and representatives of patient and 
public health advocacy organizations. Members will be invited to serve 
for overlapping terms of up to 4 years. Almost all non-Federal members 
of this committee will serve as special Government employees. The core 
of voting members may include one qualified member, selected by the 
Commissioner or designee, who is identified with consumer interests and 
is recommended by either a consortium of consumer-oriented 
organizations or other interested persons. In addition to the voting 
members, the Committee may include one or more non-voting members who 
are identified with industry interests.
    Under 5 U.S.C. 553(b)(3)(B) and (d) and 21 CFR 10.40(d) and (e), 
the Agency finds good cause to dispense with notice and public comment 
procedures and to proceed to an immediate effective date on this rule. 
Notice and public comment and a delayed effective date are unnecessary 
and are not in the public interest as this final rule merely updates 
information regarding the function of the Committee already set out in 
the charter, and updates information regarding the dates related to the 
Committee establishment in the list of standing advisory committees in 
Sec.  14.100. Therefore, the Agency is amending Sec.  14.100.
    Elsewhere in this issue of the Federal Register, FDA is publishing 
a notice requesting nominations for voting members of the Committee, a 
notice for industry organizations to participate in the nominations for 
and selection of industry representatives for the Committee, and a 
notice for consumer organizations to participate in the nominations for 
and selection of the consumer representative for the Committee.

List of Subjects in 21 CFR Part 14

    Administrative practice and procedure, Advisory committees, Color 
additives, Drugs, Radiation protection.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
14 is amended as follows:

PART 14--PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE

0
1. The authority citation for 21 CFR part 14 is revised to read as 
follows:

    Authority: 5 U.S.C. App. 2; 15 U.S.C. 1451-1461, 21 U.S.C. 41-
50, 141-149, 321-394, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 
U.S.C. 201, 262, 263b, 264; Pub. L. 107-109; Pub. L. 108-155; Pub. 
L. 113-54.


0
2. Section 14.100 is amended by revising paragraph (c)(18) to read as 
follows:


Sec.  14.100  List of standing advisory committees.

* * * * *
    (c) * * *
    (18) Pharmacy Compounding Advisory Committee.
    (i) Date re-established: April 25, 2012.
    (ii) Function: Provides advice on scientific, technical, and 
medical issues concerning drug compounding under sections 503A and 503B 
of the Federal Food, Drug, and Cosmetic Act and, as required, any other 
product for which the Food and Drug Administration has regulatory 
responsibility, and makes appropriate recommendations to the 
Commissioner of Food and Drugs.
* * * * *

    Dated: January 7, 2014.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2014-00322 Filed 1-10-14; 8:45 am]
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