[Federal Register Volume 64, Number 18 (Thursday, January 28, 1999)]
[Notices]
[Pages 4434-4435]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-2015]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98D-1266]
Draft Guidance for Industry on Placing the Therapeutic
Equivalence Code on Prescription Drug Labels and Labeling; 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availability of a draft guidance for industry entitled ``Placing the
Therapeutic Equivalence Code on Prescription Drug Labels and
Labeling.'' The draft guidance is intended to clarify for prescription
drug manufacturers, relabelers, and distributors FDA's position
regarding placing the therapeutic equivalence code on approved FDA
product labels and labeling. It also provides recommendations on how to
display therapeutic equivalence codes on labels and labeling. Inclusion
of a therapeutic equivalence code on prescription drug labels/labeling
is voluntary.
DATES: Written comments may be submitted by March 29, 1999. General
comments on agency guidance documents are welcome at any time.
ADDRESSES: Copies of the draft guidance are available on the Internet
at ``http://www.fda.gov/cder/guidance/index.htm''. Submit written
requests for single copies of the draft guidance to the Drug
Information Branch (HFD-210), Center for Drug Evaluation and Research,
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857.
Send one self-addressed adhesive label to assist that office in
processing your requests. Submit written comments on the draft guidance
to the Dockets Management Branch (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Comments are to be identified with the docket number found in brackets
in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Jerry Phillips, Center for Drug
Evaluation and Research (HFD-610), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-3225.
SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a
draft guidance for industry entitled ``Placing the Therapeutic
Equivalence Code on Prescription Drug Labels and Labeling.'' With the
repeal of section 301(l) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 331(l)) as part of the Food and Drug Administration
Modernization Act of 1997, FDA believes that it is legally permissible
to allow therapeutic equivalence codes to be placed on drug product
labels and labeling. The agency also believes that the use of
therapeutic equivalence codes will contribute to the accurate and safe
selection of generic products by pharmacists. This draft guidance is
intended to: (1) Provide a historical perspective on therapeutic
equivalence, (2) describe the process by which the agency advises the
public on the therapeutic equivalence of approved drug products, and
(3) advise manufacturers, relabelers, and distributors of the preferred
format and placement of such information on product labels. Although
inclusion of a therapeutic equivalence code on prescription drug
labels/labeling normally is voluntary, in certain cases where safety
issues are raised, the agency may ask that a code be included.
This draft level 1 guidance is being issued consistent with FDA's
good guidance practices (62 FR 8961, February 27, 1997). It represents
the agency's current thinking on placing the therapeutic equivalence
code on the labeling of prescription drug products. 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 statute, regulations, or
both.
Interested persons may, on or before March 29, 1999, submit to the
Dockets Management Branch (address above) written comments on the draft
guidance. Two copies of any comments are to be submitted, except that
individuals may submit one copy. Comments are to be identified with the
docket number found in brackets in the heading of this document. The
draft guidance and received comments may be seen in the
[[Page 4435]]
office above between 9 a.m. and 4 p.m., Monday through Friday.
Dated: January 21, 1999.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 99-2015 Filed 1-27-99; 8:45 am]
BILLING CODE 4160-01-F
