Over-the-Counter Drug Products Containing Phenylpropanolamine; Required Labeling

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