[Federal Register Volume 75, Number 59 (Monday, March 29, 2010)]
[Notices]
[Pages 15440-15441]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-6863]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


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.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance for industry entitled ``Standards for 
Securing the Drug Supply Chain-Standardized Numerical Identification 
for Prescription Drug Packages.'' This guidance is being issued under 
the Federal Food, Drug, and Cosmetic Act (the act), which requires FDA 
to develop standards for standardized numerical identifiers for 
prescription drugs.

DATES: Submit written or electronic comments on agency guidances at any 
time.

ADDRESSES: Submit written requests for single copies of this 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 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. The guidance may 
also be obtained by mail by calling CBER at 1-800-835-4709 or 301-827-
1800. Send one self-addressed adhesive label to assist that office in 
processing your requests. Submit written comments on the guidance to 
the Division of Docket 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 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; or
    Meredith Francis, Center for Drug Evaluation and Research, 10903 
New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-3476, email: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Standards for Securing the Drug Supply Chain-Standardized 
Numerical Identification for Prescription Drug Packages.'' In the 
Federal Register of January 16, 2009 (74 FR 3054), a draft version of 
this guidance was made available for public comment.
    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 the 
identification, validation, authentication, and tracking and tracing of 
prescription drugs. The statute also directs that no later than 30 
months after the date of enactment of FDAAA, the Secretary shall 
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

[[Page 15441]]

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.
    The agency received 44 comments in response to our request for 
public comment on the draft guidance. FDA also sought public comment on 
specific questions related to development of an SNI by opening a docket 
to receive information (73 FR 14988, March 20, 2008). 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. We also shared both of these requests with State 
governments, other Federal agencies, and with foreign governments. The 
standards included in this guidance are based on information received 
in response to these requests for comment and the agency's familiarity 
with identification standards already in use for certain prescription 
biologics. All of the comments that we received have been considered 
and the guidance has been revised as appropriate.
    The guidance is intended to be the first of several guidances and 
regulations that FDA may issue to implement section 505D of the act and 
its issuance is intended to assist with the development of standards 
and systems for identification, authentication, and tracking and 
tracing of prescription drugs. The guidance defines SNI for package-
level identification only. For the purpose of this guidance, FDA 
considers the package to be the smallest unit placed into interstate 
commerce by the manufacturer or the repackager that is intended by that 
manufacturer or repackager, as applicable, for individual sale to the 
pharmacy or other dispenser of the drug product. Evidence that a unit 
is intended for individual sale, and thus constitutes a separate 
``package'' for purposes of this guidance, would include evidence that 
it is accompanied by labeling intended to be sufficient to permit its 
individual distribution. This guidance is being issued consistent with 
FDA's good guidance practices regulation (21 CFR 10.115).
    The guidance does not address how to link a repackager SNI to a 
manufacturer SNI, nor does it address standards for prescription drug 
SNI at levels other than the package-level including, for example, the 
case and pallet levels. Standards for track and trace, authentication, 
and validation are also not addressed in this guidance because this 
guidance only addresses the standardized numerical identifier itself 
and not implementation or application issues.
    The guidance represents 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. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information regarding labeling requirements for 
expiration date and lot numbering in 21 CFR. Sec. Sec.  211.130, 
211.137, 201.17, and 201.18 have been approved under OMB Control No. 
0910-0139, and in Sec. Sec.  610.60 and 610.61 have been approved under 
OMB Control No. 0910-0338.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) electronic or written comments regarding this document. 
Submit a single copy of electronic 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.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/Drugs/Guidance/index.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or http://www.regulations.gov.

    Dated: March 23, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-6863 Filed 3-26-10; 8:45 am]
BILLING CODE 4160-01-S