[Federal Register Volume 61, Number 31 (Wednesday, February 14, 1996)]
[Proposed Rules]
[Pages 5912-5916]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-3323]
[[Page 5911]]
_______________________________________________________________________
Part VIII
Department of Health and Human Services
_______________________________________________________________________
Food and Drug Administration
_______________________________________________________________________
21 CFR Parts 201 and 369
Over-the-Counter Drug Products Containing Phenylpropanolamine; Required
Labeling; Proposed Rule
Federal Register / Vol. 61, No. 31 / Wednesday, February 14, 1996 /
Proposed Rules
[[Page 5912]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 201 and 369
[Docket No. 95N-0060]
Over-the-Counter Drug Products Containing Phenylpropanolamine;
Required Labeling
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
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SUMMARY: The Food and Drug Administration (FDA) is proposing new
warning labeling for all over-the-counter (OTC) drug products
containing phenylpropanolamine preparations (phenylpropanolamine
bitartrate, phenylpropanolamine hydrochloride, and phenylpropanolamine
maleate). Phenylpropanolamine is a sympathomimetic drug that is used in
OTC weight control, cough-cold, nasal decongestant, and allergy drug
products. The warnings will advise consumers not to take more than the
recommended dose of phenylpropanolamine, not to take
phenylpropanolamine with certain prescription drugs, and not to take
phenylpropanolamine under certain conditions. The warnings will also
advise consumers that they should not take a phenylpropanolamine drug
product with any other drug product containing the ingredients
phenylpropanolamine, phenylephrine, pseudoephedrine, or ephedrine,
which are sympathomimetic drugs commonly found in allergy, asthma,
cough-cold, nasal decongestant, and weight control drug products. These
drugs could be harmful if taken together.
DATES: Submit comments on the proposed regulation by May 14, 1996.
Written comments on the agency's economic impact determination by May
14, 1996. FDA is proposing that any final rule based on this proposal
be effective 6 months after the date of its publication in the Federal
Register.
ADDRESSES: 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-105), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-2304.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of September 9, 1976 (41 FR 38312), the
Advisory Review Panel on OTC Cold, Cough, Allergy, Bronchodilator, and
Antiasthmatic Drug Products (Cough-Cold Panel) recommended that
phenylpropanolamine be classified in Category I (generally recognized
as safe and effective, and not misbranded) for nasal decongestant use
at adult oral dosages equivalent to the following phenylpropanolamine
hydrochloride dosages: 25 milligrams (mg) every 4 hours (h) or 50 mg
every 8 h, not to exceed 150 mg in 24 h (41 FR 38312 at 38420). The
agency has allowed these dosages for phenylpropanolamine hydrochloride
for OTC cough-cold use and is including these dosages in this proposal.
The Federal Register of February 26, 1982 (47 FR 8466), the Advisory
Review Panel on OTC Miscellaneous Internal Drug Products (Miscellaneous
Internal Panel) recommended that phenylpropanolamine hydrochloride be
classified as Category I for weight control use in adult oral dosages
of 25 to 50 mg, not to exceed 150 mg daily. As discussed below, the
agency has limited OTC phenylpropanolamine hydrochloride dosages for
weight control to 75 mg daily and, based on its indication for use, is
including that dosage in this proposal.
After the Miscellaneous Internal Panel completed its report, the
agency became award of studies indicating that certain dosages of
phenylpropanolamine cause blood pressure elevation. These studies were
discussed in the preamble to the advance notice of proposed rulemaking
for OTC weight control drug products (47 FR 8466 through 8468). At that
time, the agency specifically requested comments and information on the
extent to which phenylpropanolamine induces or aggravates hypertension.
The agency also stated that it would not allow any increase in OTC
weight control dosages above those currently permitted: An immediate-
release dose of up to 37.5 mg and a time-release dose of up to 75 mg
phenylpropanolamine, with the total daily dose not to exceed 75 mg in
either case.
Many comments were submitted in response to the agency's request
for information concerning the safety of phenylpropanolamine. Some
comments requested that phenylpropanolamine be removed from the OTC
drug market because of its association with increased blood pressure
and other adverse effects. Other comments contended that
phenylpropanolamine is safe for OTC use.
After preliminary evaluation of the information submitted by these
comments, FDA determined that phenylpropanolamine produces hemodynamic
effects (raises blood pressure), but that the data were inadequate to
respond to the agency's safety concerns. Subsequently, in meetings with
industry on December 2, 1983, and April 11, 1984, the agency discussed
its requirements for adequate studies to address this concern about
phenylpropanolamine (Refs. 1 and 2). The agency concluded that data
were required to: (1) Determine if phenylpropanolamine plays any role
in adverse events such as stroke or seizure and other serious adverse
reactions that have been reported in association with this drug, and
(2) provide information on other possible risk factors (e.g., age,
hypertension, concomitant drug use, or disease conditions) associated
with phenylpropanolamine use.
In response to the agency's request for data and information, drug
manufacturers submitted new dose-response studies designed to
investigate the blood pressure effects of phenylpropanolamine. After
reviewing all available information, FDA remains concerned about the
possibility that phenylpropanolamine used in OTC drug products might
increase the risk of hemorrhagic stroke (Ref. 3). The possible risk of
stroke is suggested by a relatively small number of spontaneous reports
(published and unpublished) of intracranial bleeding, typically in
young, female users of phenylpropanolamine weight control drug
products, and by the known ability of phenylpropanolamine to
transiently increase blood pressure (Ref. 4). A possible mechanism of
these reported events, if indeed they are caused by
phenylpropanolamine, is an exaggerated hypertensive response, although
in most cases no large elevation in blood pressure was detected in
association with the hemorrhage. Based on the available data, the
agency cannot rule out the possibility that phenylpropanolamine may
increase the risk of stroke. This possible risk could be further
increased if the recommended dose of phenylpropanolamine was
inadvertently exceeded, e.g., taken from two products labeled for
different uses.
Because of these concerns, in 1994 the OTC drug industry initiated
a large-scale, population-based epidemiologic study of the relationship
between OTC phenylpropanolamine drug products and the incidence of
hemorrhagic stroke (Ref. 5). However, the study is not expected to be
completed until 1998.
[[Page 5913]]
The agency believes this study will provide a sufficiently large data
base to help determine whether the incidence of stroke associated with
ingestion of phenylpropanolamine is greater than the spontaneous rate
of stroke, i.e., the rate that would be expected to occur in a similar
population not using the drug. The agency does not believe, however,
based on information currently available, that phenylpropanolamine used
in OTC weight control drug products represents a substantial public
health risk. The agency, therefore, does not believe that it is
necessary to remove phenylpropanolamine weight control drug products
from the OTC market while additional data are being obtained.
While this study is being conducted, the OTC drug industry has
proposed additional labeling for OTC phenylpropanolamine weight control
drug products to help ensure that their use is confined to adults and
that the recommended dose is not exceeded (Ref. 6). Industry's proposal
includes a new warning that states: ``If nervousness, dizziness,
sleeplessness, palpitations, or headache occur, stop using this
medication and consult your physician.'' The proposal also includes a
new, separate drug interaction precaution that states:
DRUG INTERACTION PRECAUTION: If you are taking a cough-cold or
allergy medication containing any form of phenylpropanolamine, or
any type of nasal decongestant, do not take this product. Do not
take this product if you are taking any prescription drug, except
under the advice and supervision of a physician. Do not use this
product if you are presently taking a prescription monoamine oxidase
inhibitor (MAOI) for depression or for two weeks after stopping use
of an MAOI without first consulting a physician.
In addition, the OTC drug industry's proposal includes a warning
that states ``Persons between 12 and 18 are advised to consult their
physician before using this product.'' The agency believes that people
under 18 years of age should not use an OTC weight control drug product
unless specifically directed by a doctor and is modifying that
statement in Sec. 201.321(c)(1) of this proposal.
In considering these proposals, the agency notes that the
Miscellaneous Internal Panel stated that ingestion of
phenylpropanolamine can be expected to cause vasoconstriction,
bronchodilation, and tachycardia, because of its alpha and beta
adrenergic effects. Large doses would be expected to cause anxiety,
excitement, insomnia, headache, cardiac arrhythmias, convulsions, and
circulatory collapse (47 FR 8466 at 8474). The Miscellaneous Internal
Panel was concerned that a person might ingest a dose of
phenylpropanolamine to reduce nasal congestion and another dose from a
different product for weight control, and that the combined doses might
have adverse effects. Accordingly, the Miscellaneous Internal Panel
recommended a warning statement concerning this possibility on all drug
products containing phenylpropanolamine, and included the following
language in its monograph for OTC weight control drug products (47 FR
8475): ``If you are taking a cough-cold or allergy medication
containing any form of phenylpropanolamine, do not take this product.''
Many manufacturers of OTC phenylpropanolamine weight control drug
products have voluntarily included this warning in product labeling
following publication of the Miscellaneous Internal Panel's report.
However, the rulemakings for OTC phenylpropanolamine nasal decongestant
and weight control drug products will not be completed until after the
phenylpropanolamine epidemiologic study is completed and the data
assessed. The agency believes that implementation of these warnings
should not await the completion of these monograph proceedings, but
that a warning should be required on all OTC phenylpropanolamine drug
products at this time.
Similarly, because phenylpropanolamine is a sympathomimetic drug
(affects the central nervous system, cardiovascular system, and basal
metabolic rate), the agency believes that phenylpropanolamine should
not be used simultaneously with other sympathomimetic drugs, e.g.,
pseudoephedrine, ephedrine, or phenylephrine, that would have similar
effects on the body. The agency believes that labeling OTC
phenylpropanolamine drug products should advise consumers to avoid use
while they are using any other sympathomimetic drugs.
FDA concurs with the industry's labeling proposals but has
broadened the labeling to include other sympathomimetic drug
ingredients and the kinds of products in which they are used. FDA has
sufficient concern that adverse reactions could occur from taking
phenylpropanolamine in different drug products or from combining
sympathomimetic drugs; thus, this information should be included in the
``Warnings'' statement.
In the final rule for OTC nasal decongestant drug products,
published in the Federal Register of August 23, 1994 (59 FR 43386), the
agency included a drug interaction precaution statement regarding the
use of sympathomimetic drugs in combination with MAOI drugs. That
statement (in Sec. 341.80(c)(1)(i)(D)) (21 CFR 341.80(c)(1)(i)(D)
includes certain conditions (i.e., depression, psychiatric or emotional
conditions, Parkinson's disease) for which MAOI drugs are used. A
similar statement (but not listing Parkinson's disease) appears in
Sec. 341.80(c)(1)(ii)(D) for products labeled for children under 12
years of age. Products labeled for both adults and children under 12
years of age use the statement in paragraph (c)(1)(i)(D). In addition,
the statement instructs consumers to consult a health professional if
they are uncertain that they are using an MAOI drug. The agency is
proposing a shortened version of this precaution statement in the
labeling approach used in this current proposal. The agency is asking
for comments on how to further shorten or improve this precaution
statement. If a shortened version is eventually incorporated in a final
rule, the agency will revise Sec. 341.80 accordingly at that time.
II. References
The following information has been placed on display in the Dockets
Management Branch (address above) and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday through Friday.
(1) Memorandum of meeting between Industry and FDA Personnel,
December 2, 1983, coded MM0002, Docket No. 81N-0022, Dockets
Management Branch.
(2) Memorandum of meeting between Industry and FDA Personnel,
April 11, 1984, coded MM0003, Docket No. 81N-0022, Dockets
Management Branch.
(3) Comment No. LET86, Docket No. 81N-0022, Dockets Management
Branch.
(4) Blackburn, G.L. et al., ``Determinants of the Pressor Effect
of Phenylpropanolamine in Healthy Subjects,'' Journal of the
American Medical Association, 261:3267-3271, 1989, in Comment No.
C94, Vol. 6, Docket No. 81N-0022, Dockets Management Branch.
(5) Comment No. MM11, Docket No. 81N-0022, Dockets Management
Branch.
(6) Comment No. C107, Docket No. 81N-0022, Dockets Management
Branch.
III. The Agency Proposal
The agency is proposing to amend part 201 (21 CFR part 201) by
adding new Sec. 201.321 entitled: ``Over-the-counter drugs containing
phenylpropanolamine as an active ingredient; required warnings.'' This
section would require new warnings for all OTC drug products containing
phenylpropanolamine. The agency has made an effort to shorten and
simplify the labeling by combining the warnings and drug interaction
precautions under
[[Page 5914]]
four new headings in the ``Warnings'' section. Manufacturers can use
bullets or other identifying marks to emphasize the warnings. The
format of the ``Warnings'' section of the product's labeling might look
something like the following:
DO NOT TAKE MORE THAN (these words in bold print and capital
letters) 75 milligrams per day (24 hours). Taking more can be
harmful. DO NOT TAKE IF (these words in bold print and capital
letters) you have
Heart or thyroid disease
High blood pressure
An enlarged prostrate gland
Unless directed by a doctor.
STOP USING IF (these words in bold print and capital letters)
you develop
Nervousness
Dizziness
Sleeplessness
Headache
Palpitations.
If symptoms continue, ask a doctor. DO NOT USE WITH (these words
in bold print and capital letters)
A monoamine oxidase inhibitor (MAOI) (certain drugs for
depression, psychiatric or emotional conditions, or Parkinson's
disease), or for 2 weeks after stopping the MAOI drug. If unsure,
ask a health professional.
Any allergy, asthma, cough-cold, nasal decongestant, or
weight control product (containing phenylpropanolamine,
phenylephrine, pseudoephedrine, or ephedrine), or any prescription
drug, unless directed by a doctor.
The agency is proposing this format as an example of how this
warning information might be presented in a clearer and more readable
way. The agency is currently considering a new standardized format for
the labeling of all OTC drug products. (See the Federal Register of
August 16, 1995, 60 FR 42578). Thus, the format proposed in this
document may change in the future as a format is developed to label all
classes of OTC drug products. At this time, the agency is primarily
seeking specific comment on the wording of the proposed warnings for
phenylpropanolamine. Comments on the labeling format will also be
considered. As discussed below, the agency is encouraging manufacturers
to implement this proposed labeling for their phenylpropanolamine drug
products as soon as possible. The agency's proposed labeling format or
any similar format would be acceptable to use at this time.
The agency is aware that the labeling proposed by the OTC drug
industry is currently being used by some manufacturers of OTC
phenylpropanolamine weight control drug products. FDA encourages
manufacturers of all OTC drug products containing phenylpropanolamine
to implement the agency's proposed labeling statements voluntarily as
soon as possible, subject to the possibility that FDA may change the
wording of the statements, or not require the statements, as a result
of comments filed in response to this proposal. Because FDA is
encouraging that the proposed labeling statements be used on a
voluntary basis at this time, the agency advises that manufacturers
will be given ample time after publication of a final rule based on
this proposal to use up any labeling implemented in conformance with
this proposal. The agency considers these warnings to be important to
the safe use of OTC drug products containing phenylpropanolamine.
Therefore, the agency proposes that this new labeling become effective
6 months after the date of publication of the final rule in the Federal
Register. The agency proposes to revoke the existing warning statements
in Sec. 369.20 (21 CFR 369.20) for ``NASAL PREPARATIONS:
VASOCONSTRICTORS,'' and ``PHENYLPROPANOLAMINE HYDROCHLORIDE
PREPARATIONS, ORAL'' at the time that any final rule based on this
proposal becomes effective.
IV. Analysis of Impacts
FDA has examined the impacts of the proposed rule under Executive
Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354).
Executive Order 12866 directs agencies to assess all costs and benefits
of available regulatory alternatives and, when regulation is necessary,
to select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). The agency believes that
this proposed rule is consistent with the regulatory philosophy and
principles identified in the Executive Order. In addition, the proposed
rule is not a significant regulatory action as defined by the Executive
Order and, thus, is not subject to review under the Executive Order.
The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. This proposed rule will require some relabeling for
products containing phenylpropanolamine. This relabeling will impose
direct one-time costs that are expected to be minimal. Accordingly, the
agency certifies that the proposed rule will not have a significant
economic impact on a substantial number of small entities. Therefore,
under the Regulatory Flexibility Act, no further analysis is required.
The agency invites public comment regarding any substantial or
significant economic impact that this rulemaking would have on
manufacturers of drug products containing phenylpropanolamine. Comments
regarding the impact of this rulemaking on OTC phenylpropanolamine drug
products should be accompanied by appropriate documentation. A period
of 90 days from the date of publication of this proposed rulemaking in
the Federal Register will be provided for comments on this subject to
be developed and submitted. The agency will evaluate any comments and
supporting data that are received and will reassess the economic impact
of this rulemaking in the preamble to the final rule.
Paperwork Reduction Act of 1995
FDA tentatively concludes that the labeling requirements proposed
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 proposed warning 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)).
VI. Environmental Impact
The agency has determined under 21 CFR 25.24(c)(6) that this action
is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment not an environmental impact statement is
required.
VII. Request for Comments
Interested persons may, on or before May 14, 1996, submit written
comments on the proposed regulation to the Dockets Management Branch
(address above). Written comments on the agency's economic impact
determination may be submitted on or before May 14, 1996. Three copies
of all 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 and may be accompanied by a
supporting memorandum or brief. Received comments may be seen in the
office above between 9 a.m. and 4 p.m., Monday through Friday.
[[Page 5915]]
List of Subjects
21 CFR Part 201
Drugs, Labeling, Reporting and recordkeeping requirements.
21 CFR Part 369
Labeling, Medical devices, Over-the-counter drugs.
Therefore, under the Federal Food, Drug, and Cosmetic Act, and
under authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR parts 201 and 369 be amended as follows:
PART 201--LABELING
1. The authority citation for 21 CFR Part 201 continues to read as
follows:
Authority: Secs. 201, 301, 501, 502, 503, 505, 506, 507, 508,
510, 512, 530-542, 701, 704, 721 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321, 331, 351, 352, 353, 355, 356, 357, 358,
360, 360b, 360gg-360ss, 371, 374, 379e); secs. 215, 301, 351, 361 of
the Public Health Service Act (42 U.S.C. 216, 241, 262, 264).
2. New Sec. 201.321 is added to subpart G to read as follows:
Sec. 201.321 Over-the-counter drugs containing phenylpropanolamine as
an active ingredient; required labeling.
(a) Phenylpropanolamine is a sympathomimetic drug used in both
over-the-counter (OTC) weight control and nasal decongestant (cough-
cold) drug products. The Food and Drug Administration is concerned that
adverse reactions could occur if a consumer inadvertently ingests
excessive amounts of phenylpropanolamine by taking a weight control and
a cough-cold drug product containing phenylpropanolamine concurrently,
or by taking products containing phenylpropanolamine and another
sympathomimetic drug (nasal decongestant or bronchodilator)
concurrently. In addition, because phenylpropanolamine is a
sympathomimetic ingredient that interacts with monoamine oxidase
inhibitor drugs and can cause serious adverse effects, the two types of
drugs should not be taken concurrently. Further, phenylpropanolamine
should not be used by persons with high blood pressure, heart or
thyroid disease, or diabetes.
(b) Any allergy, cough-cold, or nasal decongestant drug product
containing phenylpropanolamine bitartrate, phenylpropanolamine
hydrochloride, or phenylpropanolamine maleate as an active ingredient
in an oral dosage form for OTC use as described in paragraph (a) of
this section is misbranded within the meaning of section 502 of the
Federal Food, Drug, and Cosmetic Act (the act) unless its labeling
bears the following statements under the heading ``WARNINGS:''
(1) For oral nasal decongestants labeled for adults only or for
both adults and children under 12 years of age.
(i) ``DO NOT TAKE MORE THAN'' (these five words in bold print and
capital letters) (insert maximum 150 mg daily adult dose in a 24-hour
period or maximum children's doses broken down by age groups, expressed
in units such as capsules or teaspoonfuls) ``per day (24 hours). Taking
more can be harmful.''
(ii) ``DO NOT TAKE IF'' (these four words in bold print and capital
letters) ``you have heart or thyroid disease, high blood pressure, or
an enlarged prostate gland, unless directed by a doctor.'' (Information
may be indented and/or preceded by a bullet or other identifying mark.)
(iii) ``STOP USING IF'' (these three words in bold print and
capital letters) ``you develop nervousness, dizziness, sleeplessness,
headache, or palpitations. If symptoms continue, ask a doctor.''
(Information may be indented and/or preceded by a bullet or other
identifying mark.)
(iv) ``DO NOT USE WITH'' (these four words in bold print and
capital letters) (a) ``a monoamine oxidase inhibitor (MAOI) (certain
drugs for depression, psychiatric or emotional conditions, or
Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If
unsure, ask a health professional.'' (b) ``any allergy, asthma, cough-
cold, nasal decongestant, or weight control product (containing
phenylpropanolamine, phenylephrine, pseudoephedrine, or ephedrine), or
any prescription drug, unless directed by a doctor.'' (Statements (a)
and (b) under this heading may be indented and/or preceded by a bullet
or other identifying mark.)
(2) For oral nasal decongestants labeled only for children under 12
years of age. The same labeling of the product contains the same
warnings identified in paragraph (b)(i) of this section except that the
words ``or Parkinson's disease'' under ``DO NOT USE WITH'' may be
deleted.
(c) Any weight control drug product containing phenylpropanolamine
bitartrate, phenylpropanolamine hydrochloride, or phenylpropanolamine
maleate as an active ingredient in an oral dosage form for OTC use as
described in paragraph (a) of this section is misbranded within the
meaning of section 502 of the act unless its labeling bears the
following statements under the heading ``WARNINGS:''
(1) ``For use by people 18 years of age and older.''
(2) ``DO NOT TAKE MORE THAN'' (these five words in bold print and
capital letters) (insert maximum 75 mg daily dose in a 24-hour period,
expressed in units such as capsules or tablets) ``per day (24 hours).
Taking more WILL NOT (these two words in bold print and capital
letters) increase weight loss and can be harmful.''
(3) ``DO NOT TAKE IF'' (these four words in bold print and capital
letters) ``you have heart or thyroid disease, high blood pressure, or
an enlarged prostate gland, unless directed by a doctor.'' (Information
may be indented and/or preceded by a bullet or other identifying mark.)
(4) ``STOP USING IF'' (these three words in bold print and capital
letters) ``you develop nervousness, dizziness, sleeplessness, headache,
or palpitations. If symptoms continue, ask a doctor.'' (Information may
be indented and/or preceded by a bullet or other identifying mark.)
(5) ``DO NOT USE WITH'' (these four words in bold print and capital
letters) (a) ``a monoamine oxidase inhibitor (MAOI) (certain drugs for
depression, psychiatric or emotional conditions, or Parkinson's
disease), or for 2 weeks after stopping the MAOI drug. If unsure, ask a
health professional.'' (b) ``any allergy, asthma, cough-cold, nasal
decongestant, or weight control product (containing
phenylpropanolamine, phenylephrine, pseudoephedrine, or ephedrine), or
any prescription drug, unless directed by a doctor.'' (Statements (a)
and (b) under this heading may be indented and/or preceded by a bullet
or other identifying mark.)
(d) After (date 6 months after date of publication of the final
rule in the Federal Register), any such OTC drug product initially
introduced or initially delivered for introduction into interstate
commerce, or any such drug product that is repackaged or relabeled
after this date regardless of the date the product was manufactured,
initially introduced, or initially delivered for introduction into
interstate commerce, that is not in compliance with this section is
subject to regulatory action.
PART 369--INTERPRETATIVE STATEMENTS RE WARNINGS ON DRUGS AND
DEVICES FOR OVER-THE-COUNTER SALE
3. The authority citation for 21 CFR part 369 continues to read as
follows:
Authority: Secs. 201, 301, 501, 502, 503, 505, 506, 507, 701 of
the Federal Food, Drug,
[[Page 5916]]
and Cosmetic Act (21 U.S.C. 321, 331, 351, 352, 353, 355, 356, 357,
371).
Sec. 369.20 [Amended]
4. Section 369.20 Drugs; recommended warning and caution statements
is amended by removing the entries for ``NASAL PREPARATIONS:
VASOCONSTRICTORS,'' and ``PHENYLPROPANOLAMINE HYDROCHLORIDE
PREPARATIONS, ORAL.''
Dated: February 6, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-3323 Filed 2-13-96; 8:45 am]
BILLING CODE 4160-01-P