[Federal Register Volume 67, Number 30 (Wednesday, February 13, 2002)]
[Rules and Regulations]
[Pages 6645-6647]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-3282]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 203 and 205

[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, 2003, 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. In the 
Federal Register of March 1, 2001 (66 FR 12850), the agency further 
delayed the effective date of those requirements until April 1, 2002. 
This action further delays the effective date of these requirements 
until April 1, 2003. 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. As explained in the SUPPLEMENTARY INFORMATION 
section, the delay will allow additional time for Congress and FDA to 
consider whether legislative and regulatory changes are appropriate.
    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)(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.

[[Page 6646]]

553(b)(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 the agency 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 
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 Secs. 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, 2003. Submit written or electronic 
comments by April 15, 2002.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document. Submit 
electronic comments on the Internet at http://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Lee D. Korb, 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, 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 letters and 
petitions and had other communications with industry, industry trade 
associations, and members of Congress objecting to the provisions in 
Secs. 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 for stay of action requesting that the relevant provisions of 
the final rule be stayed until October 1, 2001. The agency also 
received a petition for reconsideration 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 submissions on 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 as a service to the hospitals and patients they 
serve.
    Based on the concerns expressed by industry, industry associations, 
and Congress about implementing Secs. 203.3(u) and 203.50 by the 
December 4, 2000, effective date, the agency published a document 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 action 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 action also reopened the 
administrative record and gave interested persons until July 3, 2000, 
to submit written comments. As stated in the May 2000 action, the 
purpose of delaying the effective date for these provisions was to give 
the agency time to obtain more information about the possible 
consequences of implementing them and to further evaluate the issues 
involved.
    On May 16, 2000, the House Committee on Appropriations (the 
Committee) stated in its report accompanying the Agriculture, Rural 
Development, FDA, 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 for the relevant 
requirements of the final rule, the agency decided to hold a public 
hearing to elicit comment from interested persons on the requirements. 
In the Federal Register of September 19, 2000 (65 FR 56480), the agency 
announced that a public hearing would be held on October 27, 2000, to 
discuss the requirements at issue (i.e., the requirements for 
unauthorized distributors and the provisions relating to distribution 
of blood derivatives by health care entities). 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 the provisions relating to wholesale distribution of 
prescription drugs by unauthorized distributors (i.e., Secs. 203.3(u) 
and 203.50). The agency also further delayed 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 on unauthorized distributor and blood derivative 
issues, 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, Congress would have to act to amend section 503(e) of the act 
to make the types of changes requested by the secondary wholesale 
industry.
    FDA has decided that, in light of the fact that only legislative 
action can address some of the concerns raised by the secondary 
wholesale industry, it is appropriate to further delay the effective 
date of the relevant provisions of the final rule for another year 
until April 1, 2003. The delay will give Congress 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.

[[Page 6647]]

    This action is being taken under FDA's authority under 21 CFR 
10.35(a). The Commissioner of Food and Drugs finds that this further 
delay of the effective date is in the public interest.

    Dated: February 5, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-3282 Filed 2-12-02; 8:45 am]
BILLING CODE 4160-01-S