[Federal Register Volume 71, Number 114 (Wednesday, June 14, 2006)]
[Rules and Regulations]
[Pages 34249-34251]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-5362]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 203

[Docket Nos. 1992N-0297 (Formerly 92N-0297), 1988N-0258 (Formerly 88N-
0258), 2006D-0226]


Prescription Drug Marketing Act Pedigree Requirements; Effective 
Date and Compliance Policy Guide; Request for Comment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; announcement of effective date; notice of 
availability; request for comment.

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SUMMARY: The Food and Drug Administration (FDA) does not intend to 
further delay the effective date of certain provisions of the final 
regulation published in the Federal Register of

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December 3, 1999 (64 FR 67720). The provisions will therefore go into 
effect on December 1, 2006. In addition, FDA is announcing the 
availability of a new compliance policy guide (CPG) 160.900 entitled 
``Prescription Drug Marketing Act Pedigree Requirements Under 21 CFR 
Part 203'' for public comment. This CPG describes how the agency 
intends to prioritize its enforcement efforts during the next year with 
respect to pedigree requirements set forth in the Federal Food, Drug, 
and Cosmetic Act (the act) and certain FDA regulations.

DATES: The effective date for Sec. Sec.  203.3(u) and 203.50 is 
December 1, 2006. You may submit written or electronic comments on the 
CPG by July 14, 2006.

ADDRESSES: Submit written requests for single copies of the guidance to 
the Division of Compliance Policy (HFC-230), Office of Enforcement, 
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. 
Send one self-addressed adhesive label to assist that office in 
processing your request or include a fax number to which the guidance 
may be sent. Submit written comments on the CPG to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20857. Submit electronic comments 
to http://www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the CPG document.

FOR FURTHER INFORMATION CONTACT:  Ilisa Bernstein, Office of Policy 
(HF-11), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 
20857, 301-827-3360.

SUPPLEMENTARY INFORMATION:

I. Background

A. Implementation of Sec. Sec.  203.3(u) and 203.50 of 21 CFR Part 203

    The Prescription Drug Marketing Act of 1987 (the PDMA), as modified 
by the Prescription Drug Amendments of 1992, amended sections 301, 303, 
503, and 801 of the act (21 U.S.C. 331, 333, 353, 381) to establish, 
among other things, requirements related to the wholesale distribution 
of prescription drugs. A primary purpose of the PDMA was to increase 
safeguards to prevent the introduction and retail sale of substandard, 
ineffective, and counterfeit drugs in the U.S. drug supply chain.
    Section 503(e)(1)(A) of the act establishes the so-called 
``pedigree'' requirement for prescription drugs. A drug pedigree is a 
statement of origin that identifies each prior sale, purchase, or trade 
of a drug, including the dates of those transactions and the names and 
addresses of all parties to them. Under the pedigree requirement, each 
person who is engaged in the wholesale distribution of a prescription 
drug in interstate commerce, who is not the manufacturer or an 
authorized distributor of record for that drug, must provide to the 
person who receives the drug a pedigree for that drug. The PDMA states 
that an authorized distributor of record is a wholesaler that has an 
``ongoing relationship'' with a manufacturer to distribute that 
manufacturer's drug. However, the PDMA does not define ``ongoing 
relationship.''
    In 1999, FDA published final regulations implementing the PDMA 
(part 203 (21 CFR part 203)). The regulations were to take effect in 
December 2000. After publication of the 1999 final rule, the agency 
received comments objecting to the provisions in Sec. Sec.  203.3(u) 
and 203.50. Section 203.3(u) defines ``ongoing relationship'' to 
include a written agreement between manufacturer and wholesaler. 
Section 203.50 specifies the fields of information that must be 
included in the drug pedigree and states that the information must be 
traceable back to the first sale by the manufacturer. Based on concerns 
raised by various stakeholders, the agency delayed the effective date 
of Sec. Sec.  203.3(u) and 203.50 several times.
    Most recently, in February 2004, FDA delayed the effective date of 
Sec. Sec.  203.3(u) and 203.50 until December 1, 2006, in part because 
we were informed by stakeholders in the U.S. drug supply chain that the 
industry would voluntarily implement electronic track and trace 
technology by 2007. If widely adopted, this technology could create a 
de facto electronic pedigree documenting the sale of a drug product 
from its place of manufacture through the U.S. drug supply chain to the 
final dispenser. If properly implemented, an electronic record could 
thus meet the pedigree requirements in section 503(e)(1)(A) of the act. 
Based on a recent fact-finding effort by FDA to assess the use of e-
pedigree across the supply chain, however, it appears that industry 
will not fully implement track and trace technology by 2007.
    Today, the agency is announcing that it does not intend to delay 
the effective date of Sec. Sec.  203.3(u) and 203.50 beyond December 1, 
2006. As such, these provisions defining ``ongoing relationship'' and 
setting forth requirements regarding the information that must appear 
in pedigrees will go into effect as of December 1, 2006.

B. CPG

    We are issuing a draft CPG that describes how we plan to prioritize 
our enforcement actions during the next year with respect to these new 
requirements. To this end, FDA is announcing the availability of a new 
CPG Section 160.900, entitled ``Prescription Drug Marketing Act 
Pedigree Requirements Under 21 CFR Part 203.'' This CPG, which the 
agency is publishing in draft for comment, lists factors that FDA field 
personnel are expected to consider in prioritizing FDA's pedigree-
related enforcement efforts during the next year. Consistent with our 
risk-based approach to the regulation of pharmaceuticals, these factors 
focus our resources on drug products that are most vulnerable to 
counterfeiting and diversion or that are otherwise involved in illegal 
activity.
    FDA has not provided in the CPG a list of drug products that have 
been counterfeited in the past. We solicit comment on the merit of 
providing such a list.
    The priorities described in the CPG reflect a phased-in type 
approach to the enforcement of the stayed pedigree provisions. The CPG 
will expire 1 year after the final CPG is issued. By providing guidance 
on the types of drugs that are currently of greatest concern to FDA, we 
believe that wholesale distributors will have a better idea of where 
and how to focus their initial energies as they implement systems to 
come into complete compliance with part 203 for all the prescription 
drugs they distribute.
    FDA is issuing this CPG as a level 1 guidance consistent with FDA's 
good guidance practices regulations (21 CFR 10.115).
    We note that guidance documents are not binding on FDA or industry, 
and, under appropriate circumstances, the agency may initiate 
regulatory action, including a criminal prosecution, for pedigree 
violations that do not meet the factors set forth in the CPG.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments on the CPG document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. The guidance and received comments may 
be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday.

[[Page 34251]]

III. Electronic Access

    An electronic version of this guidance is available on the Internet 
at http://www.fda.gov/ora under ``Compliance Reference''.

    Dated: June 7, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 06-5362 Filed 6-9-06; 9:35 am]
BILLING CODE 4160-01-S