Draft Guidance for Industry on Placing the Therapeutic Equivalence Code on Prescription Drug Labels and Labeling; Availability

[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Draft Guidance for Industry on Placing the Therapeutic 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availability of a draft guidance for industry entitled ``Placing the 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 The draft guidance is intended to clarify for prescription 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ADDRESSES: Copies of the draft guidance are available on the Internet 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 ``https://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requests for single copies of the draft guidance to the Drug 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 Submit written comments on the draft guidance 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draft guidance for industry entitled ``Placing the Therapeutic 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