[Federal Register Volume 61, Number 47 (Friday, March 8, 1996)]
[Rules and Regulations]
[Pages 9570-9571]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-5444]




[[Page 9569]]

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Part IV





Department of Health and Human Services





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Food and Drug Administration



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21 CFR Part 310



Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products 
for Over-the-Counter Human Use; OTC Nasal Decongestant Drug Products; 
Partial Stay of Final Rule; Enforcement Policy

  Federal Register / Vol. 61, No. 47 / Friday, March 8, 1996 / Rules 
and Regulations  
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[[Page 9570]]


DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 310

[Docket No. 76N-052N]
RIN 0910-AA01


Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug 
Products for Over-the-Counter Human Use; OTC Nasal Decongestant Drug 
Products; Partial Stay of Final Rule; Enforcement Policy

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; partial stay of regulation; enforcement policy.

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SUMMARY: The Food and Drug Administration (FDA) is staying part of a 
final rule that established that certain over-the-counter (OTC) nasal 
decongestant drug products are not generally recognized as safe and 
effective and are misbranded. This action is being taken in response to 
a citizen petition for a stay of enforcement of regulatory action 
against OTC nasal decongestant drug products containing the active 
ingredient l-desoxyephedrine. The agency is also providing labeling 
requirements for OTC topical nasal decongestant drug products 
containing l-desoxyephedrine. This action is part of the ongoing review 
of OTC drug products conducted by FDA.

DATES: This partial stay is effective August 31, 1995. On or after 
September 9, 1996, no OTC drug product containing l-desoxyephedrine may 
be initially introduced or initially delivered for introduction into 
interstate commerce unless its labeling conforms to the conditions of 
this partial stay.

FOR FURTHER INFORMATION CONTACT: William E. Gilbertson, Center for Drug 
Evaluation and Research (HFD-105), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-2304.

SUPPLEMENTARY INFORMATION:

 I. Background

     In the Federal Register of August 23, 1994 (59 FR 43386), the 
agency published a final rule in the form of a final monograph 
establishing conditions under which OTC nasal decongestant drug 
products are generally recognized as safe and effective. The final 
monograph did not include l-desoxyephedrine as a nasal decongestant 
active ingredient. The final rule listed l-desoxyephedrine in 
Sec. 310.545(a)(6)(ii)(B) (21 CFR 310.545(a)(6)(ii)(B)) as not 
generally recognized as safe and effective. L-desoxyephedrine was 
declared nonmonograph because it was not currently standardized and 
characterized for quality and purity in an official compendium, i.e., 
the United States Pharmacopeia (USP)/National Formulary (NF) (59 FR 
43386 at 43408). The agency stated in the final rule that OTC drug 
products containing l-desoxyephedrine as a topical nasal decongestant 
active ingredient were new drugs under section 201(p) of the Federal 
Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 321(p)). The 
effective date of the final rule was August 23, 1995. To be marketed, 
OTC topical nasal decongestant drug products containing l-
desoxyephedrine would require an application or abbreviated application 
approved under section 505 of the act (21 U.S.C. 355) and part 314 (21 
CFR part 314). In the absence of an approved application, OTC topical 
nasal decongestant drug products containing l-desoxyephedrine would be 
misbranded under section 502 of the act (21 U.S.C. 352). The agency 
also stated that should interested parties develop appropriate 
standards that are included in the USP, the nasal decongestant final 
monograph would be amended to include l-desoxyephedrine as a topical 
nasal decongestant active ingredient. The agency reserved 21 CFR 
341.20(b)(1) of the final monograph for OTC nasal decongestant drug 
products for possible future inclusion of l-desoxyephedrine as a 
topical nasal decongestant active ingredient.
     Subsequently, a citizen petition (Ref. 1) requested that the 
agency defer the effective date of Sec. 310.545(a)(6)(ii)(B) as it 
applies to l-desoxyephedrine (topical) until December 31, 1996. The 
petitioner stated that it had forwarded a draft compendial monograph 
(Ref. 2) for 1-desoxyephedrine to the USP in late July 1995. The 
petition stated that USP expects to publish a proposed monograph for 
public comment in the November/December 1995 issue of Pharmacopeial 
Forum, and expects the resulting monograph to become official with 
publication of USP23/NF18 Supplement No. 5, on November 15, 1996. The 
petition stated that USP, as a practical matter, will have concluded to 
adopt the monograph for l-desoxyephedrine well before November 15, 
1996, and will have given notice of that conclusion in its 
Pharmacopeial Forum Interim Revision Announcement. The petitioner 
stated its belief that the agency should have ample time to initiate 
its process to amend the nasal decongestant final monograph by the end 
of 1996.
     The agency was subsequently informed that the ingredient might 
become official in the USP in November 1996 or May 1997 (Ref. 3). On 
August 31, 1995, the agency stated its intent to stay the effective 
date for l-desoxyephedrine in the list of active ingredients in 
Sec. 310.545(a)(6)(ii)(B) until December 31, 1996, to permit time for 
USP processing to include the ingredient in a compendial monograph 
(Ref. 4). At this time, the agency is staying the entry for ``l-
desoxyephedrine (topical)'' in Sec. 310.545(a)(6)(ii)(B) until further 
notice. When l-desoxyephedrine becomes official in the USP, the final 
monograph for OTC nasal decongestant drug products will be amended to 
include the ingredient and Sec. 310.545(a)(6)(ii)(B) will be revised 
accordingly.
     During the stay period, the following labeling requirements will 
be in effect for topical nasal decongestant drug products containing l-
desoxyephedrine:
     1. The statement of identity should follow Sec. 341.80(a) (21 CFR 
341.80(a)) of the final monograph for OTC nasal decongestant drug 
products (59 FR 43386 at 43409).
     2. The indications should follow Sec. 341.80(b) of the final 
monograph for OTC nasal decongestant drug products (59 FR 43386 at 
43409 and 43410).
    3. The warnings should follow Sec. 341.80(c)(2)(i) of the final 
monograph for OTC nasal decongestant drug products (59 FR 43386 at 
43410). In addition, the following warnings are required: ``Do not use 
this product for more than 7 days. Use only as directed. Frequent or 
prolonged use may cause nasal congestion to recur or worsen. If 
symptoms persist, consult a doctor.''
    4. The directions are for a product that must deliver 0.04 to 0.150 
milligram of l-desoxyephedrine in each 800 milliliters of air. Adults 
and children 12 years of age and over: Two inhalations in each nostril 
not more often than every 2 hours. Children 6 to under 12 years of age 
(with adult supervision): One inhalation in each nostril not more often 
than every 2 hours. Children under 6 years of age: Consult a doctor.
    5. Other required statements should follow Sec. 341.80(d)(viii)(A) 
and (d)(viii)(B).
     As part of the conditions of this stay of action, the agency has 
determined that manufacturers of OTC topical nasal decongestant drug 
products containing l-desoxyephedrine should implement this labeling 
within 6 months of the publication of this partial stay. Therefore, on 
or after September 9, 

[[Page 9571]]
1996, no OTC drug product that is subject to this partial stay of the 
final rule for OTC nasal decongestant drug products may be initially 
introduced or initially delivered for introduction into interstate 
commerce unless its labeling conforms to the conditions of this partial 
stay. Further, any OTC drug product subject to this partial stay that 
is repackaged or relabeled after the date of publication of this 
partial stay must be in compliance with the partial stay regardless of 
the date the product was initially introduced or initially delivered 
for introduction into interstate commerce. Manufacturers are encouraged 
to comply voluntarily with this partial stay at the earliest possible 
date.
     This partial stay of action applies only to l-desoxyephedrine in 
OTC topical nasal decongestant drug products and not to any other nasal 
decongestant active ingredient included under 
Sec. 310.545(a)(6)(ii)(B).

 II. References

     The following references are on display in the Dockets Management 
Branch (HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 
1-23, Rockville, MD 20857, and may be seen by interested persons 
between 9 a.m. and 4 p.m., Monday through Friday.
     (1) Comment No. CP1, Docket No. 95P-0245, Dockets Management 
Branch.
     (2) Draft Compendial Monograph, in Comment No. CP1, Docket No. 
95P-0245, Dockets Management Branch.
     (3) Memorandum of telephone conversation between M. T. Benson, 
FDA, ---and T. Cecil, United States Pharmacopeial Convention, Inc., 
coded as MT1, Docket No. 95P-0245, Dockets Management Branch.
     (4) Letter from W. E. Gilbertson, FDA, to S. Rexinger, Leiner 
Health ---Products, and E. Lambert, Covington & Burling, coded as 
LET1, Docket No. --95P-0245, Dockets Management Branch.

 III. Paperwork Reduction Act of 1995

     FDA concludes that the labeling requirements discussed in this 
document are not subject to review by the Office of Management and 
Budget because they do not constitute a ``collection of information'' 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). 
Rather, the labeling statements are a ``public disclosure of 
information originally supplied by the Federal government to the 
recipient for the purpose of disclosure to the public'' (5 CFR 
1320.3(c)(2)).----

 List of Subjects in 21 CFR Part 310

     Administrative practice and procedure, Drugs, Labeling, Medical 
devices, Reporting and recordkeeping requirements.
     Therefore, under the Federal Food, Drug, and Cosmetic Act and 
under authority delegated to the Commissioner of Food and Drugs, 21 CFR 
part 310 is amended as follows:

 PART 310--NEW DRUGS

     1. The authority citation for 21 CFR part 310 continues to read as 
follows:

    -Authority: Secs. 201, 301, 501, 502, 503, 505, 506, 507, 512-
516, 520, 601(a), 701, 704, 705, 721 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321, 331, 351, 352, 353, 355, 356, 357, 
360b-360f, 360j, 361(a), 371, 374, 375, 379e); secs. 215, 301, 
302(a), 351, 354-360F of the Public Health Service Act (42 U.S.C. 
216, 241, 242(a), 262, 263b-263n).

Sec.  310.545  [Partial stay]

     2. In Sec. 310.545 Drug products containing certain active 
ingredients offered over-the-counter (OTC) for certain uses in 
paragraph (a)(6)(ii)(B), the entry for ``l-desoxyephedrine (topical)'' 
is stayed until further notice.

    Dated: February 22, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-5444 Filed 3-7-96; 8:45 am]
BILLING CODE 4160-01-F