[Federal Register Volume 74, Number 11 (Friday, January 16, 2009)]
[Notices]
[Pages 3054-3055]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-833]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0001]


Draft Guidance for Industry on Standards for Securing the Drug 
Supply Chain--Standardized Numerical Identification for Prescription 
Drug Packages; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``Standards for 
Securing the Drug Supply Chain--Standardized Numerical Identification 
for Prescription Drug Packages.'' This draft guidance is being issued 
under the Federal Food, Drug, and Cosmetic Act (the act), which 
requires FDA to develop standardized numerical identifiers for 
prescription drugs. We are also requesting responses from interested 
stakeholders to questions posed in this Federal Register notice related 
to the draft guidance.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 
by April 16, 2009.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002 or to 
the Office of Communication, Outreach and Development (HFM-40), Center 
for Biologics Evaluation and Research (CBER), Food and Drug 
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448. Send one self-addressed adhesive label to assist that office in 
processing your requests. The draft guidance may also be obtained by 
mail by calling CBER at 1-800-835-4709 or 301-827-1800. Submit written 
comments on the draft guidance to the Division of Dockets Management 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT:
    Ilisa B.G. Bernstein, Office of the Commissioner/Office of Policy, 
Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, 
MD 20993-0002, 301-796-4840, e-mail: [email protected];
    Stephen Ripley, Center for Biologics Evaluation and Research (HFM-
17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, 
Rockville, MD 20852, 301-827-6210, e-mail: [email protected];
    Jennifer Devine, Center for Drug Evaluation and Research, 10903 New 
Hampshire Ave.,Silver Spring, MD 20993-0002, 301-796-3347, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Draft Guidance for Industry on Standards for Securing the 
Drug Supply Chain--Standardized Numerical Identification for 
Prescription Drug Packages.'' On September 27, 2007, the Food and Drug 
Administration Amendments Act of 2007 (FDAAA) (Public Law 110-85) was 
signed into law. Section 913 of this legislation created section 505D 
of the act, which requires the Secretary of Health and Human Services 
(the Secretary) to develop standards and identify and validate 
effective technologies for the purpose of securing the drug supply 
chain against counterfeit, diverted, subpotent, substandard, 
adulterated, misbranded, or expired drugs. Section 505D of the act 
directs the Secretary to consult with specific entities to prioritize 
and develop standards for identification, validation, authentication, 
and tracking and tracing of prescription drugs. No later than 30 months 
after the date of enactment of FDAAA, the statute also directs the 
Secretary to develop a standardized numerical identifier (SNI) to be 
applied to a prescription drug at the point of manufacturing and 
repackaging at the package or pallet level, sufficient to facilitate 
the identification, validation, authentication, and tracking and 
tracing of the prescription drug. An SNI applied at the point of 
repackaging is to be linked to the SNI applied at the point of 
manufacturing, and to the extent practicable, the SNI should be 
harmonized with international consensus standards for such an 
identifier. (See section 505D(b)(2) of the act.) The provisions in 
section 505D(b) of the act complement and build on FDA's longstanding 
efforts to further secure the U.S. drug supply.
    FDA sought public comment on specific questions related to 
development of an SNI. We received 59 comments from a range of 
stakeholders including manufacturers, wholesalers, pharmacies, trade 
and health professional organizations, technology vendors, health 
professionals, consumers, and state governments. The standards included 
in this draft guidance are based on information received in response to 
our request for comment and the agency's familiarity with 
identification standards already in use for certain prescription 
biologics.
    This draft guidance addresses only package-level SNI. Linking of a 
repackager SNI to a manufacturer SNI is not addressed in this guidance. 
Additionally, standards for track and trace, authentication, and 
validation are not included in this guidance. This draft guidance is 
intended to be the first of several guidances and regulations that FDA 
may issue to implement section 505D of the act; issuance of this 
guidance is intended to assist with the development of standards and 
systems for identification, authentication, and tracking and tracing of 
prescription drugs.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the agency's current thinking on Standards 
for Drug Supply Chain Security--Standardized Numerical Identification 
for Prescription Drug Packages. 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 
requirements of the applicable statutes and regulations.

II. Request for Information

    To assist us in finalizing the draft guidance and aid us in future 
guidance development and rulemaking related to section 505D of the act, 
we are seeking responses from interested stakeholders on the following 
questions. We also

[[Page 3055]]

welcome comment on any aspect of the draft guidance.
    1. We believe that the serialized National Drug Code (sNDC) 
described in the draft guidance is appropriate for package level 
identification for most prescription drugs; however, it might not be 
useful at the pallet or other intermediate level, such as the case. We 
did not receive many comments related to standards for numerical 
identification at the case or pallet level and would like broader input 
on this subject. Please comment on whether there are any standards that 
would be appropriate for serialization or other numerical 
identification at the case or pallet level.
    2. Some comments recommended that the SNI allow for alpha-numeric 
serial numbers in order to increase the choices for the numbers. FDA's 
draft guidance recommends that the SNI for most prescription drug 
packages be an sNDC, consisting of the NDC plus a unique 8-digit 
numerical serial number. Given the FDA recommendation for SNI, please 
comment on the necessity of having the serial number allow for alpha-
numeric possibilities and under what standards this might be achieved.
    3. Blood and blood components currently use either the ISBT 128 
standard or Codabar for product package identification. In addition, 
hematopoietic stem cells derived from peripheral and cord blood use the 
ISBT 128 standard for product package identification. Please comment on 
whether these standards should be designated as the SNI for such 
products.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this 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. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS at http://www.regulations.gov.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
http://www.fda.gov/cder/guidance/index.htm, http://www.fda.gov/cber/guidelines.htm, or http://www.regulations.gov.

    Dated: January 8, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-833 Filed 1-15-09; 8:45 am]
BILLING CODE 4160-01-S