[Federal Register Volume 68, Number 21 (Friday, January 31, 2003)]
[Rules and Regulations]
[Pages 4912-4913]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-2293]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 203

[Docket No. 92N-0297]
RIN 0905-AC81


Prescription Drug Marketing Act of 1987; Prescription Drug 
Amendments of 1992; Policies, Requirements, and Administrative 
Procedures; Delay of Effective Date

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; delay of effective date.

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SUMMARY: The Food and Drug Administration (FDA) is further delaying, 
until April 1, 2004, the effective date of certain requirements of a 
final rule published in the Federal Register of December 3, 1999 (64 FR 
67720). In the Federal Register of May 3, 2000 (65 FR 25639), the 
agency delayed until October 1, 2001, the effective date of certain 
requirements in the final rule relating to wholesale distribution of 
prescription drugs by distributors that are not authorized distributors 
of record, and distribution of blood derivatives by entities that meet 
the definition of a ``health care entity'' in the final rule. The 
agency further delayed the effective date of these requirements in two 
subsequent Federal Register documents. Most recently, in the Federal 
Register of February 13, 2002 (67 FR 6645), FDA delayed the effective 
date until April 1, 2003. This action further delays the effective date 
of these requirements until April 1, 2004. The final rule implements 
the Prescription Drug Marketing Act of 1987 (PDMA), as modified by the 
Prescription Drug Amendments of 1992 (PDA), and the Food and Drug 
Administration Modernization Act of 1997 (the Modernization Act). The 
agency is taking this action to address concerns about the requirements 
raised by affected parties.
    To the extent that 5 U.S.C. 553 applies to this action, it is 
exempt from notice and comment because it constitutes a rule of 
procedure under 5 U.S.C. 553(b)(3)(A). Alternatively, the agency's 
implementation of this action without opportunity for public comment, 
effective immediately upon publication today in the Federal Register, 
is based on the good cause exceptions in 5 U.S.C. 553(b)(3)(B) and 
(d)(3). Seeking public comment is impracticable, unnecessary, and 
contrary to the public interest. As explained in the SUPPLEMENTARY 
INFORMATION section, FDA has prepared a report for Congress and 
concluded that although FDA can address some of industry's concerns 
with the PDMA regulation through regulatory changes, other concerns 
would have to be addressed by Congress through legislative action. The 
further delay is necessary to give Congress additional time to consider 
the information and conclusions contained in the agency's report, and 
to determine if legislative action is appropriate. The further delay 
will also give the agency additional time to consider whether 
regulatory changes are appropriate and, if so, to initiate such 
changes.

DATES: The effective date for Sec. Sec.  203.3(u) and 203.50, and the 
applicability of Sec.  203.3(q) to wholesale distribution of blood 
derivatives by health care entities, added at 64 FR 67720, December 3, 
1999, is delayed until April 1, 2004. Submit written or electronic 
comments by April 1, 2003.

[[Page 4913]]


ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20857. All comments should be identified with the docket 
number found in brackets in the heading of this document. Submit 
electronic comments to http://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Aileen H. Ciampa, Center for Drug 
Evaluation and Research (HFD-7), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-2041.

SUPPLEMENTARY INFORMATION: PDMA (Public Law 100-293) was enacted on 
April 22, 1988, and was modified by the PDA (Public Law 102-353, 106 
Stat. 941) on August 26, 1992. The PDMA, as modified by the PDA, 
amended sections 301, 303, 503, and 801 of the Federal Food, Drug, and 
Cosmetic Act (the act) (21 U.S.C. 331, 333, 353, and 381) to, among 
other things, establish requirements for the wholesale distribution of 
prescription drugs and for the distribution of blood derived 
prescription drug products by health care entities.
    On December 3, 1999, the agency published final regulations in part 
203 (21 CFR part 203) implementing PDMA (64 FR 67720). After 
publication of the final rule, the agency received communications from 
industry, industry trade associations, and members of Congress 
objecting to the provisions in Sec. Sec.  203.3(u) and 203.50. On March 
29, 2000, the agency met with representatives from the wholesale drug 
industry and industry associations to discuss their concerns. In 
addition, FDA received a petition requesting that the relevant 
provisions of the final rule be stayed until October 1, 2001. The 
agency also received a petition from the Small Business Administration 
requesting that FDA reconsider the final rule and suspend its effective 
date based on the severe economic impact it would have on more than 
4,000 small businesses.
    In addition to the communications regarding wholesale distribution 
by unauthorized distributors, the agency received several letters on, 
and held several meetings to discuss, the implications of the final 
regulations for blood centers that distribute blood derivative products 
and provide health care to hospitals and patients.
    Based on the concerns expressed by industry, industry associations, 
and Congress about implementing Sec. Sec.  203.3(u) and 203.50 by the 
December 4, 2000, effective date, the agency published a notice in the 
Federal Register of May 3, 2000 (65 FR 25639), delaying the effective 
date for those provisions until October 1, 2001. In addition, the May 
2000 document delayed the applicability of Sec.  203.3(q) to wholesale 
distribution of blood derivatives by health care entities until October 
1, 2001. The May 2000 document also reopened the administrative record 
to give interested persons until July 3, 2000, to submit written 
comments.
    On May 16, 2000, the House Committee on Appropriations (the 
Committee) stated in its report accompanying the Agriculture, Rural 
Development, Food and Drug Administration, and Related Agencies 
Appropriations Bill, 2001 (H. Rept. 106-619) that it supported the 
``recent FDA action to delay the effective date for implementing 
certain requirements of the Prescription Drug Marketing Act until 
October 1, 2001, and reopen the administrative record in order to 
receive additional comments.'' In addition, the Committee stated that 
it ``believes the agency should thoroughly review the potential impact 
of the proposed provisions on the secondary wholesale pharmaceutical 
industry.'' The Committee directed the agency to provide a report to 
the Committee summarizing the comments and issues raised and agency 
plans to address the concerns.
    After issuing the delay of the effective date, the agency announced 
in the Federal Register of September 19, 2000 (65 FR 56480), that a 
public hearing would be held to discuss the requirements at issue. The 
hearing was held on October 27, 2000, and comments were accepted until 
November 20, 2000.
    In the Federal Register of March 1, 2001 (66 FR 12850), the agency 
announced that it was further delaying, until April 1, 2002, the 
effective date of Sec. Sec.  203.3(u) and 203.50, and the applicability 
of Sec.  203.3(q) to wholesale distribution of blood derivatives by 
health care entities. As explained by the agency, the effective date 
was further delayed to give FDA additional time to consider comments 
and testimony received, for FDA to prepare its report to Congress, and, 
if appropriate, for Congress or the agency to make legislative or 
regulatory changes. The report was completed and submitted to Congress 
on June 7, 2001.
    In its report to Congress, the agency concluded that it could 
address some, but not all, of the concerns raised by the secondary 
wholesale industry and the blood industry through regulatory changes. 
However, to make other changes requested by the secondary wholesale 
industry, Congress would have to amend section 503(e) of the act. As a 
result, on February 13, 2002, FDA further delayed the effective date of 
the relevant provisions of the final rule until April 1, 2003, in part 
to give Congress time to consider the information and conclusions 
contained in the agency's report and to determine if legislative action 
was appropriate. Based on a recent petition submitted by affected 
parties, FDA understands that members of Congress are, in fact, 
considering the issues presented in the agency's report. Due to 
competing legislative priorities, however, the issues have not yet been 
resolved. Therefore, to give Congress additional time to determine if 
legislative action is appropriate, the agency is further delaying the 
effective date for Sec. Sec.  203.3(u) and 203.50, and the 
applicability of Sec.  203.3(q) to wholesale distribution of blood 
derivatives by health care entities. The further delay of the effective 
date until April 1, 2004, will also give the agency additional time to 
consider whether regulatory changes are warranted.
    FDA has examined the impacts of this delay of effective date under 
Executive Order 12866. Executive Order 12866 directs agencies to assess 
all costs and benefits of available regulatory alternatives and, when 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety, and other advantages; distributive impacts; and 
equity). The agency believes that this action is consistent with the 
regulatory philosophy and principles identified in the Executive order. 
This action will ease the burden on industry by delaying the effect of 
Sec. Sec.  203.3(u) and 203.50, and the applicability of Sec.  203.3(q) 
to wholesale distribution of blood derivatives by health care entities 
while Congress considers taking legislative action. Thus, this action 
is not a significant action as defined by the Executive order.
    This action is being taken under FDA's authority under 21 CFR 
10.35(a). The Commissioner of Food and Drugs finds that this delay of 
the effective date is in the public interest.

    Dated: January 23, 2003.
Margaret M. Dotzel,
Assistant Commissioner for Policy.
[FR Doc. 03-2293 Filed 1-30-03; 8:45 am]
BILLING CODE 4160-01-S