FDA Modernization Act of 1997: Guidance for Industry on Implementation of Section 126, Elimination of Certain Labeling Requirements; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 98D-0133]

FDA Modernization Act of 1997: Guidance for Industry on

Implementation of Section 126, Elimination of Certain Labeling

Requirements; 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 ``Implementation of

Section 126, Elimination of Certain Labeling Requirements, of the Food

and Drug Administration Modernization Act of 1997.'' The Food and Drug

Administration Modernization Act of 1997 (FDAMA) amends the Federal

Food, Drug, and Cosmetic Act (the act) to require, at a minimum, that

before dispensing, the labels of prescription products contain the

symbol ``Rx only'' instead of the ``Caution: Federal law prohibits

dispensing without prescription'' statement. In addition, the

requirement that the labels of certain habit-forming drugs bear the

statement ``Warning--May be habit forming'' has been repealed. This

guidance is intended to clarify FDA policy with respect to

implementation of these amendments that became effective February 19,

1998. The agency requested comments on this guidance.

DATES: Written comments may be submitted at any time.

ADDRESSES: Copies of this guidance may be obtained on the Internet at

http://www.fda.gov/cder/guidance/index.htm. Submit written requests for

single copies of this 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 guidance to the Dockets

Management Branch (HFA-305), Food and Drug Administration, 12420

Parklawn Dr., rm. 1-23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Jerry Phillips, Center for Drug

Evaluation and Research (HFD-610), Food and Drug Administration, Office

of Generic Drugs, 7500 Standish Pl., Rockville, MD 20855, 301-827-5846.

SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a

guidance for industry entitled ``Implementation of Section 126,

Elimination of Certain Labeling Requirements, of the Food and Drug

Administration Modernization Act of 1997.'' Section 126 of Title I of

the Food and Drug Administration Modernization Act of 1997 (Pub. L.

105-115), signed into law by President Clinton on November 21, 1997,

amends section 503(b)(4) of the Federal Food, Drug, and Cosmetic Act

(the act) (21 U.S.C. 353(b)(4)) to require, at a minimum, that prior to

dispensing, the label of prescription products contain the symbol ``Rx

only.'' In addition, section 502(d) of the act (21 U.S.C. 352(d)) is

repealed. This section required the labels of certain habit-forming

drugs to bear the statement ``Warning--May be habit forming.'' The

amendments to section 503(b)(4) of the act and the repeal of section

502(d) of the act became effective February 19, 1998.

This guidance for industry is intended to: (1) Describe the new

prescription drug labeling requirements of the act as amended by FDAMA

and (2) advise manufacturers, packers, and distributors of the policy

the agency will follow in implementing the requirements of section 126.

The guidance advises that, for a limited period of time, FDA does not

intend to object if manufacturers, packers, or distributors of already

approved products implement section 126 of FDAMA at the time of next

printing of its labels, but that such entities should implement the

[[Page 12474]]

amendments no later than August 18, 1998, which is 180 days from the

effective date of FDAMA. For full or abbreviated applications approved

between February 19, 1998, and August 18, 1998, manufacturers, packers,

and distributors have until August 18, 1998, to comply with the

amendments. The guidance also advises that full or abbreviated

applications submitted after February 19, 1998, should provide labels

in compliance with the amendments.

This guidance document represents the agency's current thinking on

implementation of elimination of certain labeling requirements. 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 requirement of the applicable statute,

regulations, or both.

Interested persons may, at any time, submit written comments on the

guidance to the dockets Management Branch (address above). 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 guidance and received

comments are available for public examination in the Dockets Management

Branch between 9 a.m. and 4 p.m., Monday through Friday.

Dated: March 3, 1998.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 98-6572 Filed 3-13-98; 8:45 am]

BILLING CODE 4160-01-F