[Federal Register: June 7, 2002 (Volume 67, Number 110)]
[Page 39409-39410]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 02D-0242]

Pharmacy Compounding Compliance Policy Guide; Availability

AGENCY:  Food and Drug Administration, HHS

ACTION:  Notice.


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 

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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the guidance document.

Evaluation and Research (HFD-330), Food and Drug Administration, 7520 
Standish Pl., Rockville, MD 20855, 301-594-0101.


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 

[[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 

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/guidance/index.htm, http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ora 
under ``Compliance References,'' or http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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]