[Federal Register Volume 67, Number 110 (Friday, June 7, 2002)]
[Notices]
[Pages 39409-39410]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-14259]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 02D-0242]
Pharmacy Compounding Compliance Policy Guide; Availability
AGENCY: Food and Drug Administration, HHS
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for FDA staff and industry entitled ``Sec.
460.200 Pharmacy Compounding.'' The document being issued with this
notice provides guidance to drug compounders on how FDA intends to
address pharmacy compounding as a result of a recent decision by the
Supreme Court.
DATES: Submit written or electronic comments on the guidance at any
time.
ADDRESSES: Submit written requests for single copies of the guidance
to the Division of Drug Information (HFD-240), Center for Drug
Evaluation and Research, Food and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, or to the Division of Compliance Policy
(HFC-230), Office of Regulatory Affairs, Food and Drug Administration,
5600 Fishers Lane, Rockville, MD 20857. Send one self-addressed
adhesive label to assist in processing your requests. Submit written
comments on the guidance to the Dockets Management Branch (HFA-305),
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville,
MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.
FOR FURTHER INFORMATION CONTACT: Fred Richman, Center for Drug
Evaluation and Research (HFD-330), Food and Drug Administration, 7520
Standish Pl., Rockville, MD 20855, 301-594-0101.
SUPPLEMENTARY INFORMATION:
I. Background
On March 16, 1992, FDA issued a CPG, section 460.200 (formerly CPG
7132.16), which delineated FDA's enforcement policy on pharmacy
compounding. This CPG represented FDA's policy in this area until
November 1997, when the President signed into law the Food and Drug
Administration Modernization Act of 1997 (FDAMA) (Public Law 105-115).
Section 127 of FDAMA added section 503A to the Federal Food, Drug, and
Cosmetic Act (the act) (21 U.S.C. 353a), which exempted compounded drug
products from the requirements of sections 501(a)(2)(B) (current good
manufacturing practices), 502(f)(1) (adequate directions for use), and
505 (new drug provisions) of the act (21 U.S.C. 351(a)(2)(B),
352(f)(1), and 355), provided that the compounding was conducted in
accordance with and the drug products met the requirements in section
503A of the act.
In November 1998, the solicitation and advertising provisions of
section
[[Page 39410]]
503A were challenged by seven compounding pharmacies as being
impermissible regulation of commercial speech. The U.S. District Court
for the District of Nevada ruled in the plaintiffs' favor. The
Government appealed to the U.S. Court of Appeals for the Ninth Circuit.
On February 6, 2001, the Court of Appeals declared section 503A invalid
in its entirety (Western States Medical Center v. Shalala, 238 F.3rd
1090 (9th Cir. 2001)). The Government petitioned for a writ of
certiorari to the U.S. Supreme Court for review of the circuit court
opinion. The Supreme Court granted the writ and issued its decision in
the case on April 29, 2002, (Thompson v. Western States Medical Center,
No. 01-344, April 29, 2002).
The Supreme Court affirmed the Ninth Circuit Court of Appeals
decision that found section 503A of the act to be invalid in its
entirety because it contained unconstitutional restrictions on
commercial speech (i.e., prohibitions on soliciting prescriptions for
and advertising specific compounded drugs). The Supreme Court did not
rule on, and therefore left in place, the Ninth Circuit's holding that
the unconstitutional restrictions on commercial speech could not be
severed from the rest of section 503A of the act. Accordingly, all of
section 503A is now invalid.
FDA has therefore determined that it needs to issue guidance to the
compounding industry and FDA staff on what types of compounding might
be subject to enforcement action under current law.
This guidance is being issued as a level 1 guidance consistent with
our good guidance practices (GGPs) regulation in Sec. 10.115 (21 CFR
10.115). It is being implemented immediately without prior public
comment, under Sec. 21 CFR 10.115(g)(2), because of the agency's urgent
need to explain how, in light of the Supreme Court decision, it will
exercise its enforcement discretion in regard to compounded human
drugs. However, pursuant to GGPs, FDA requests comments on the guidance
and will revise the document, if appropriate. Comments will be
considered by the agency in the development of future policy.
This guidance represents the agency's current thinking on the
enforcement of the act in regard to drug products compounded by
pharmacies. It does not create or confer any rights for or on any
person and does not operate to bind FDA or the public. An alternative
approach may be used if such approach satisfies the applicable statutes
and regulations.
II. Comments
Interested persons may, at any time, submit written or electronic
comments on the guidance to the Dockets Management Branch (see
ADDRESSES). Two copies of any comments are to be submitted, except that
individuals may submit one copy. Comments are to be identified with the
docket number found in brackets in the heading of this document. The
guidance and received comments are available for public examination in
the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through
Friday.
III. Electronic Access
Persons with access to the Internet may obtain the document at
http://www.fda.gov/cder/guidance/index.htm, http://www.fda.gov/ora
under ``Compliance References,'' or http://www.fda.gov/ohrms/dockets/default.htm.
Dated: May 30, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-14259 Filed 6-4-02; 8:45 am]
BILLING CODE 4160-01-S