[Printable PDF]
[Federal Register: March 18, 2004 (Volume 69, Number 53)]
[Rules and Regulations]
[Page 12792-12794]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18mr04-6]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 203
[Docket No. 1992N-0297]
RIN 0905-AC81
Prescription Drug Marketing Act of 1987; Prescription Drug
Amendments of1992; Policies, Requirements, and Administrative
Procedures; Delay of Effective Date; Correction
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; delay of effective date; correction.
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SUMMARY: On February 23, 2004 (69 FR 8105), FDA published a delay of
the effective date of certain requirements in a final rule published in
the Federal Register of December 3, 1999 (64 FR 67720). FDA is
correcting typographical errors in the SUMMARY and SUPPLEMENTARY
INFORMATION sections of the February 23, 2004, document.
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: The SUMMARY and SUPPLEMENTARY INFORMATION
sections of the document published on February 23, 2004 (69 FR 8105),
are corrected as follows:
1. In the second paragraph of the SUMMARY, in the second from last
sentence, the words ``Therefore, it is necessary to delay the effective
date of Sec. Sec. 203.3(u) and 203.50 (21 CFR 203.3(u) and 203.50)
until December 1, 2007 * * *'' is corrected to read ``Therefore, it is
necessary to delay the effective date of Sec. Sec. 203.3(u) and 203.50
(21 CFR 203.3(u) and 203.50) until December 1, 2006 * * *''.
2. In the SUPPLEMENTARY INFORMATION section in the ninth paragraph,
the last sentence is corrected to read as follows: ``The agency's
decision to delay the effective date of Sec. Sec. 203.3(u) and 203.50
was based, in part, on comments received on FDA's Counterfeit Drug Task
Force's Interim Report (Docket 03N-0361).''
3. In the SUPPLEMENTARY INFORMATION section, in the tenth
paragraph, the second from last sentence is corrected to read as
follows: ``One comment suggested an interim solution of a ``one
forward, one back'' pedigree for those drugs most likely to be
counterfeited.''
4. In the SUPPLEMENTARY INFORMATION section, in the thirteenth
paragraph, the first two sentences are corrected to read as follows:
``Although FDA is further delaying the effective date of Sec. Sec.
203.3(u) and 203.50, the agency encourages wholesalers to provide
pedigree information that documents the prior history of the product,
particularly for those drugs most likely to be counterfeited, even when
such a pedigree is not required by the act. The suggestion from the
comments that there be a one-forward, one-back pedigree for those drugs
most likely to be counterfeited until an electronic pedigree is
uniformly adopted may have some merit.''
Dated: March 12, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
For the convenience of the reader, the text of the February 23,
2004, document as corrected, is reprinted as follows:
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 203
[Docket No. 1992N-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.
SUMMARY: The Food and Drug Administration (FDA) is further delaying
until December 1, 2006, 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 three subsequent Federal Register
notices. Most recently, in the Federal Register of January 31, 2003
(68 FR 4912), FDA delayed the effective date until April 1, 2004.
This action further delays the effective date of these requirements
until December 1, 2006. 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 in the
final rule raised by affected parties.
As explained in the SUPPLEMENTARY INFORMATIONsection, FDA is
working with stakeholders through its counterfeit drug initiative to
facilitate widespread, voluntary adoption of track and trace
technologies that
[[Page 12793]]
will generate a de facto electronic pedigree, including prior
transaction history back to the original manufacturer, as a routine
course of business. If this technology is widely adopted, it is
expected to help fulfill the pedigree requirements of the PDMA and
obviate or resolve many of the concerns that have been raised with
respect to the final rule by ensuring that an electronic pedigree
travels with a drug product at all times. Therefore, it is necessary
to delay the effective date of Sec. Sec. 203.3(u) and 203.50 (21
CFR 203.3(u) and 203.50) until December 1, 2006 to allow
stakeholders time to continue to move toward this goal. In addition,
the further delay of the applicability of Sec. 203.3(q) to
wholesale distribution of blood derivatives by health care entities
is necessary to 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 December 1, 2006. Submit written
or electronic comments by April 23, 2004.
ADDRESSES: Submit written comments to the Division of Dockets
Management (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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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, 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) that were
to take effect on December 4, 2000. 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. Respectively, these
provisions define the phrase ``ongoing relationship'' as used in the
definition of ``authorized distributor of record'' and set forth
requirements regarding an ``identifying statement'' (commonly
referred to as a ``pedigree'').
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
delayed the effective date for those provisions until October 1,
2001 (65 FR 25639). FDA also delayed the applicability of Sec.
203.3(q) to wholesale distribution of blood derivatives by health
care entities until October 1, 2001, and reopened the administrative
record to give interested persons until July 3, 2000, to submit
written comments. The rest of the regulations took effect on
December 4, 2000.
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.'' The Committee further 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.
On March 1, 2001, FDA again delayed the effective dates of the
provisions to allow time for the agency to consider the comments and
testimony received at an October 27, 2000, public hearing and to
prepare its report to Congress (65 FR 56480). The agency's report,
which was submitted to Congress on June 7, 2001, concluded that FDA
could address some 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.
Since submitting its report to Congress, FDA has delayed the
effective date of the provisions two more times, most recently until
April 1, 2004. On both occasions, the effective date was delayed in
order to give Congress additional time to determine whether
legislative action was appropriate and to give the agency time to
consider whether regulatory changes were warranted (67 FR 6645; 68
FR 4912).
Today, the agency is further delaying, until December 1, 2006,
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. The agency's decision to delay
the effective date of Sec. Sec. 203.3(u) and 203.50 was based, in
part, on comments received on FDA's Counterfeit Drug Task Force's
Interim Report (Docket 03N-0361).
As part of its Counterfeit Drug Initiative, FDA sought comment
on the most effective ways to achieve the goals of PDMA. In
particular, given recent or impending advances in technology, the
agency requested comment on the feasibility of using an electronic
pedigree in lieu of a paper pedigree. Although many comments
received by the Task Force supported the use of paper pedigrees for
their deterrent value and as a means to verify prior sales through
due diligence, the majority of comments confirmed that significant
concerns persist regarding the feasibility and limitations of full
implementation of the PDMA pedigree requirements. Some comments
suggested a risk-based approach to implementing PDMA, focusing on
those drugs at high risk for counterfeiting. For example, some
comments suggested that drugs at high risk for counterfeiting
maintain a full pedigree that documents all sales and transactions
back to the manufacturer. One comment suggested an interim solution
of a ``one forward, one back'' pedigree for those drugs most likely
to be counterfeited. The majority of comments, however, supported
the eventual use of an electronic pedigree for all drug products in
the supply chain and indicated that an electronic pedigree should be
considered as a long-term solution to fulfilling the PDMA
requirements codified at Sec. 203.50.
In response to these comments, FDA is continuing to work closely
with affected parties to identify and resolve concerns related to
the implementation of the pedigree requirements of the PDMA. FDA is
encouraged by the enthusiasm and interest that stakeholders in the
U.S. drug supply chain have expressed toward the adoption of
sophisticated track and trace technologies. Although there are
technical, operational, and regulatory issues that have yet to be
resolved, these are being considered and addressed by FDA and
stakeholders. Currently, it appears that industry will migrate
toward and implement electronic track and trace capability by 2007.
If this capability is widely adopted, a de facto electronic pedigree
will follow the product from the place of manufacture through the
U.S. drug supply chain to the final dispenser. If properly
implemented, this electronic pedigree could meet the statutory
requirement in 21 U.S.C. 353(e)(1)(A) that ``each person who is
engaged in the wholesale distribution of a drug*** who is not the
manufacturer or authorized distributor of record of such drug***
provide to the person who receives the drug a statement (in such
form and containing such information as the Secretary may require)
identifying each prior sale, purchase, or trade of such drug
(including the date of the transaction and the names and addresses
of all parties to the transaction.)'' The permanent electronic
pedigree would address the concerns that have been expressed by
[[Page 12794]]
wholesalers, particularly secondary wholesalers, regarding access to
pedigrees because the required information would travel with the
product at all times, regardless of whether a party to the
transaction is an authorized distributor of record.
Until the electronic pedigree is in widespread use, FDA believes
that the multi-layer strategies and measures discussed in the FDA's
Counterfeit Drug Final Report (Final Report) can help reduce the
likelihood that counterfeit drugs will be introduced into the U.S.
drug distribution system. These measures, combined with
implementation of Radio Frequency Identification (RFID) technology,
could provide effective long-term protections to help minimize the
number of counterfeit drug products in the U.S. distribution system.
As discussed in greater detail in the Final Report, such long-term
measures include the following: Use of authentication technologies
in products and packaging and labeling, in particular, for drugs
most likely to be counterfeited; adoption of secure business
practices by stakeholders; adoption of the revised model rules for
wholesale distributor licensure by States; stronger criminal
penalties and enforcement at the State and national levels; and
education and outreach to stakeholders, including greater
communication through the counterfeit alert network.
Although FDA is further delaying the effective date of
Sec. Sec. 203.3(u) and 203.50, the agency encourages wholesalers to
provide pedigree information that documents the prior history of the
product, particularly for those drugs most likely to be
counterfeited, even when such a pedigree is not required by the act.
The suggestion from the comments that there be a one-forward, one-
back pedigree for those drugs most likely to be counterfeited until
an electronic pedigree is uniformly adopted may have some merit.
However, FDA believes legislative changes would be needed before it
could adopt such a system.
To summarize, FDA has concluded that an electronic pedigree
should accomplish and surpass the goals of PDMA and is potentially a
more effective solution to tracing the movement of pharmaceuticals
than a paper pedigree. As stated previously, it appears that
industry will migrate toward and implement electronic track and
trace capability by 2007. Therefore, to allow stakeholders to
continue to move toward this goal, FDA has decided to delay the
effective date of Sec. Sec. 203.3(u) and 203.50 until December 1,
2006. Before the effective date, FDA intends to evaluate the
progress toward implementation of the electronic pedigree and its
capacity to meet the intent of PDMA, and determine whether to
further delay the effective date of the regulations or take other
appropriate regulatory action.
FDA is also further delaying the applicability of Sec. 203.3(q)
to wholesale distribution of blood derivatives by health care
entities. This further delay is necessary to give FDA additional
time to address concerns about the requirements raised by affected
parties and consider whether regulatory changes are appropriate and,
if so, initiate such changes.
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 FDA
works with industry to resolve concerns about these provisions
either with the implementation of technological solutions
(Sec. Sec. 203.3(u) and 203.50) or the consideration of possible
regulatory changes (Sec. 203.3(q)). Thus, this action is not a
significant action as defined by the Executive order.
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.
553(b)(B) and (d)(3). Seeking public comment is impracticable,
unnecessary, and contrary to the public interest. In addition, given
the imminence of the current compliance date, seeking prior public
comment on this delay is contrary to the public interest in the
orderly issuance and implementation of regulations. Notice and
comment procedures in this instance would create uncertainty,
confusion, and undue financial hardship because, during the time
that the agency would be proposing to extend the compliance date for
the requirements identified below, those companies affected would
have to be preparing to comply with the April 1, 2004, compliance
date. In accordance with 21 CFR 10.40(c)(1), FDA is also providing
an opportunity for comment on whether this delay should be modified
or revoked.
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: February 17, 2004
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-6094 Filed 3-17-04; 8:45 am]
BILLING CODE 4160-01-S