[Federal Register Volume 76, Number 223 (Friday, November 18, 2011)]
[Notices]
[Pages 71577-71578]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-29877]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0074]


Guidance for Industry on Medication Guide Distribution 
Requirements and Inclusion of Medication Guides in Risk Evaluation and 
Mitigation Strategies; 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 guidance for industry entitled ``Medication Guides--
Distribution Requirements and Inclusion in Risk Evaluation and 
Mitigation Strategies (REMS).'' This guidance addresses two topics 
pertaining to Medication Guides for drug and biological products. 
First, the guidance addresses when FDA intends to exercise enforcement 
discretion regarding when a Medication Guide must be provided with a 
drug or biological product that is dispensed to a health care 
professional for administration to a patient instead of being dispensed 
directly to the patient for self-administration or to the patient's 
caregiver for administration to the patient. Second, the guidance 
addresses when a Medication Guide will be required as part of a REMS. 
The guidance is intended to answer questions that have arisen 
concerning these topics.

DATES: Submit either electronic or written 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, 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. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the guidance document.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Kristen E. Miller, Center for Drug Evaluation and Research, Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6226, 
Silver Spring, MD 20993-0002, (301) 796-5400;
     or
Stephen Ripley, Center for Biologics Evaluation and Research (HFM-17), 
Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-
1448, (301) 827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Medication Guides--Distribution Requirements and Inclusion 
in Risk Evaluation and Mitigation Strategies (REMS).'' This guidance 
provides information for industry, health care providers, and 
authorized dispensers of prescription drug products. The guidance 
addresses two topics pertaining to Medication Guides for drug and 
biological products.
    Medication Guides are primarily for prescription drug and 
biological products used on an outpatient basis without direct 
supervision by a health care professional. Questions have arisen 
concerning when a Medication Guide must be provided with a drug or 
biological product that is dispensed to a health care professional for 
administration to a patient in certain situations, for example, in an 
inpatient setting or an outpatient setting such as a clinic or infusion 
center. This guidance is intended to articulate the circumstances under 
which FDA intends to exercise enforcement discretion regarding 
Medication Guide distribution.
    The second topic addressed by the guidance is when a Medication 
Guide

[[Page 71578]]

will be required as part of a REMS. Under section 505-1(e) of the 
Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355-
1(e)), FDA may require that a REMS for a drug include one or more of 
the elements described in section 505-1(e), including the requirement 
for an applicant to develop a Medication Guide for distribution to each 
patient when the drug is dispensed (when the criteria in part 208 (21 
CFR part 208) are met). Since the enactment of the Food and Drug 
Administration Amendments Act of 2007, FDA has, as a matter of policy, 
considered any new Medication Guide (or safety-related changes to an 
existing Medication Guide) to be part of a REMS. However, the Agency 
has the authority to determine, based on the risks of a drug and public 
health concern, how a Medication Guide should be required when the 
standard in part 208 is met. Based on the risks and public health 
concern, the Agency may require: (1) A Medication Guide in accordance 
with part 208 that is not an element of a REMS or (2) A Medication 
Guide in accordance with part 208 and section 505-1 of the FD&C Act 
that is an element of a REMS, which may include other elements of a 
REMS (such as elements to assure safe use).
    In the Federal Register of February 28, 2011 (76 FR 10908), FDA 
announced the availability of a draft guidance for industry entitled 
``Medication Guides--Distribution Requirements and Inclusion in Risk 
Evaluation and Mitigation Strategies (REMS).'' The notice gave 
interested parties the opportunity to comment by May 31, 2011. The 
Agency considered all of the comments received and made minor editorial 
and clarifying changes to the guidance.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
Agency's current thinking on when FDA intends to exercise enforcement 
discretion regarding Medication Guide distribution and inclusion of 
Medication Guides in REMS. 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. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed comments. Identify 
comments 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.

III. 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 in 21 CFR 314.70 and 601.12 have been 
approved under OMB control numbers 0910-0001 and 0910-0338, 
respectively; the collections of information in part 208 have been 
approved under OMB control number 0910-0393.

IV. Electronic Access

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

    Dated: November 14, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-29877 Filed 11-17-11; 8:45 am]
BILLING CODE 4160-01-P