[Federal Register Volume 76, Number 39 (Monday, February 28, 2011)]
[Notices]
[Pages 10908-10909]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-4341]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Draft Guidance for Industry on Medication Guides--Distribution 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availability of a draft guidance for industry entitled ``Medication 
Guides--Distribution Requirements and Inclusion in Risk Evaluation and 
Mitigation Strategies (REMS).'' This draft guidance addresses two 
topics pertaining to Medication Guides for drug and biological 
products. First, the draft guidance addresses when FDA intends to 
exercise enforcement discretion regarding dispensing requirements for 
Medication Guides that must be distributed with a drug or biological 
product dispensed to a healthcare 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 Second, the draft guidance addresses when a Medication Guide 
will be required as part of a REMS. The draft guidance is intended to 
answer questions that have arisen concerning these topics.

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by May 31, 2011.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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 
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 draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug

[[Page 10909]]

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 draft guidance for industry 
entitled ``Medication Guides--Distribution Requirements and Inclusion 
of Medication Guides in Risk Evaluation and Mitigation Strategies 
(REMS).'' This draft guidance is intended to address 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 healthcare professional. Questions have arisen 
concerning when a Medication Guide must be distributed with a drug or 
biological product dispensed to a healthcare 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 draft 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 draft guidance is when a 
Medication Guide 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 (when the 
criteria in part 208 (21 CFR part 208) are met), the requirement for an 
applicant to develop a Medication Guide for distribution to each 
patient when the drug is dispensed. 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 a 
part of a REMS or
    (2) A Medication Guide in accordance with part 208 and section 505-
1 of the FD&C Act that is part of a REMS, which will include other 
parts of a REMS (such as the timetable for submission of assessments) 
and possibly other REMS elements (including elements to assure safe 
use).
    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 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 draft 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 Sec. Sec.  314.70 and 600.12 have been 
approved under OMB control numbers 0910-0001 and 0910-0338; 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 
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or 
http://www.regulations.gov.

    Dated: February 17, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-4341 Filed 2-25-11; 8:45 am]
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