[Federal Register Volume 60, Number 167 (Tuesday, August 29, 1995)]
[Proposed Rules]
[Pages 44787-44788]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-21480]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Parts 310 and 341

[Docket No. 95N-0205]
Rin 0905-AA06


Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug 
Products for Over-the-Counter Human Use; Proposed Amendment of 
Monograph for OTC Bronchodilator Drug Products; Extension of Comment 
Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of proposed rulemaking; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is extending to 
September 27, 1995, the period for comments for the notice of proposed 
rulemaking to amend the monograph for over-the-counter (OTC) 
bronchodilator drug products that was published in the Federal Register 
of July 27, 1995. That document proposed to remove the ingredients 
ephedrine, ephedrine hydrochloride, ephedrine sulfate, and racephedrine 
hydrochloride from the final monograph for OTC bronchodilator drug 
products and to classify these ingredients as not generally recognized 
as safe and effective for OTC use. FDA is taking this action in 
response to several requests to extend the period for comments to allow 
interested persons adequate time to assess and respond to the proposal.

DATES: Written comments by September 27, 1995.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr., 
Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: William E. Gilbertson, Center for Drug 
Evaluation and Research (HFD-810), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-5000.

SUPPLEMENTARY INFORMATION: In the Federal Register of July 27, 1995 (60 
FR 38643), FDA published a notice of proposed rulemaking to amend the 
final monograph for OTC bronchodilator drug products to remove the 
ingredients ephedrine, ephedrine hydrochloride, ephedrine sulfate, and 
racephedrine hydrochloride and to classify these ingredients as not 
generally recognized as safe and effective for OTC use. Interested 
persons were given until August 28, 1995 to submit comments on the 
proposal.
    In the proposal, the agency indicated that these ingredients should 
no longer be included in the final monograph for OTC bronchodilator 
drug products based on their extensive use in illicit drug manufacture 
and their potential for causing harm as a result of misuse and abuse. 
This proposed amendment to the monograph, if finalized, would remove 
these ingredients from the OTC market whether present as single 
ingredient products or in combination with other cough-cold 
ingredients.
    FDA has received requests from a manufacturers' association and two 
manufacturers of OTC bronchodilator drug products to extend the comment 
period until October 27, 1995, to permit adequate development of 
comments by industry and other interested parties. The requests stated 
that the extension is necessary because of the summer vacation season 
and the inability to develop a responsive submission in 30 days as 
provided in the proposed monograph amendment.
    One comment indicated that FDA's action could set a precedent for 
the agency to take action later concerning OTC drug products containing 
pseudoephedrine and phenylpropanolamine, which are also included in the 
Domestic Chemical Diversion Control Act of 1993 as listed 
chemicals used as precursors in the clandestine manufacture 
of methamphetamine and metcathinone. The comment added that because the 
proposed amendment to the monograph could have profound implication on 
the entire OTC drug industry, additional time to comment is necessary 
to evaluate the legal and policy implications for companies who make 
products containing pseudoephedrine and/or phenylpropanolamine.
    FDA emphasizes that this proposal affects ephedrine ingredients 
only. The proposed amendment does not affect the current OTC marketing 
status of pseudoephedrine or phenylpropanolamine in any manner. 
However, because of the comment's concerns that the proposal may have a 
potential future impact on the OTC drug industry, the agency wants to 
allow additional time for interested persons and manufacturers to more 
fully express their views. However, because of the continuing misuse 
and abuse of OTC ephedrine drug products, the agency has determined 
that the additional period shall be 30 days only. Therefore, the agency 
is providing an extension of the period for comments until September 
27, 1995.
    Interested persons may, on or before September 27, 1995, submit to 
the Dockets Management Branch (address above) written comments on the 
proposed monograph amendment. 

[[Page 44788]]
Three 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. 
Received comments may be seen in the office above between 9 a.m. and 4 
p.m., Monday through Friday.

    Dated: August 24, 1995.
Ronald G. Chesemore,
Associate Commissioner for Regulatory Affairs.
[FR Doc. 95-21480 Filed 8-25-95; 11:05 am]
BILLING CODE 4160-01-F