[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
