[Federal Register Volume 60, Number 144 (Thursday, July 27, 1995)]
[Proposed Rules]
[Pages 38643-38647]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-18448]
Federal Register / Vol. 60, No. 144 / Thursday, July 27, 1995 /
Proposed Rules
[[Page 38643]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
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
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of proposed rulemaking.
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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend
the final monograph for over-the-counter (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. This action is being taken in response to a request from the U.S.
Department of Justice, Drug Enforcement Administration (DEA) to
restrict OTC availability of ephedrine because of its illicit use as
the primary precursor utilized in the synthesis of the controlled
substances methamphetamine and methcathinone. This action is also based
on new information that shows that the misuse and abuse of OTC
ephedrine drug products has the potential for causing harm and on
comments made by FDA's Pulmonary-Allergy Drugs Advisory Committee and
the Nonprescription Drugs Advisory Committee on November 14, 1994. This
proposal is part of the ongoing review of OTC drug products conducted
by FDA.
DATES: Written comments or objections by August 28, 1995; written
comments on the agency's economic impact determination by August 28,
1995. FDA is proposing that any final rule that may issue based on this
proposal become effective 30 days after its date of publication in the
Federal Register.
ADDRESSES: Submit written comments or objections 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:
I. Background-
In the Federal Register of September 9, l976 (41 FR 38312), FDA
published, under Sec. 330.10(a)(6) (21 CFR 330.10(a)(6)), an advance
notice of proposed rulemaking to establish a monograph for OTC cold,
cough, allergy, bronchodilator, and antiasthmatic drug products,
together with the recommendations of the Advisory Review Panel on OTC
Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products
(the Panel), which was the advisory review panel responsible for
evaluating data on the active ingredients in this drug class. The Panel
recommended that ephedrine preparations be Category I (generally
recognized as safe and effective) for OTC bronchodilator use (41 FR
38312 at 38370 and 38371, September 9, 1976). The agency concurred with
the Panel in the bronchodilator tentative final monograph (47 FR 47520
at 47527, October 26, 1982) and included ephedrine preparations in the
final monograph for OTC bronchodilator drug products (51 FR 35326 at
35339, October 2, 1986).
II. Recent Developments
Since publication of the final monograph for OTC bronchodilator
drug products, the agency's views about OTC ephedrine-containing
bronchodilator drug products have changed for several reasons: (1) A
large-scale diversion of OTC ephedrine-containing drug products to
illicit use in the manufacture of the controlled substances
methamphetamine and methcathinone, (2) new information that ephedrine
may be unsafe for OTC use and has the potential for causing harm as a
result of misuse and abuse, due to widespread and easy availability as
an OTC drug, and (3) the consensus of FDA's Pulmonary-Allergy Drugs
Advisory Committee and the Nonprescription Drugs Advisory Committee
(the Committee) on November 14, 1994, that the use of oral ephedrine
drug products as an OTC bronchodilator to relieve the symptoms of
asthma can no longer be justified when the drug's potential for illicit
use and misuse is considered.
III. Illicit Use of OTC Ephedrine Drug Products
FDA has received correspondence and inquiries from consumers, U.S.
Senators, DEA, and others (Ref. 1) concerning the need for additional
controls on the distribution of OTC ephedrine-containing drug products.
The ``Domestic Chemical Diversion Control Act of 1993, Pub. L. 103-
200'' was signed into law on December 17, 1993, to control the
diversion of certain chemicals (e.g., ephedrine) used in the illicit
production of controlled substances such as methcathinone and
methamphetamine. The law became effective on April 16, 1994, and
removed the exemption from the definition of a ``regulated
transaction'' that had existed for single entity ephedrine drug
products legally marketed under the Federal Food, Drug, and Cosmetic
Act (the act). Thus, drugs that were previously marketed lawfully under
the act are no longer exempt from chemical precursor controls. The new
law was intended to close this loophole and help eliminate the
availability of ephedrine as a raw material source in the clandestine
synthesis of methamphetamine and methcathinone.-
In the Federal Register of October 11, 1994 (59 FR 51365), DEA
issued a final rule eliminating the threshold for ephedrine and
subjecting all transactions involving bulk ephedrine and single entity
ephedrine drug products to the applicable provisions of the Controlled
Substances Act (21 U.S.C. 801). The final rule eliminated the threshold
(an amount of a listed chemical that determines if a transaction such
as receipt or sale of the chemical is a regulated transaction under
part 1310 (21 CFR part 1310)) for single entity ephedrine drug
products. The final rule established that all transactions involving
ephedrine, regardless of size, are subject to recordkeeping and
reporting requirements set forth in part 1310 and the notification
provisions of part 1310 (21 CFR part 1313). However, the final rule did
not apply to combination drug products containing ephedrine.
At the Committee meeting on November 14, 1994, the Committees
discussed OTC bronchodilator drug products. DEA had submitted a comment
(Ref. 2) to the Committee expressing its concern that, although the
recent legislation and proposed regulations (59 FR 12562, March 17,
1994) (now final regulations (59 FR 51365)) adequately address the
ability to control single ingredient ephedrine products, DEA is aware
that laboratories may turn to combination drug products containing
ephedrine and guaifenesin that would be exempt from the final rule.
The comment stated that the illicit use of OTC ephedrine drug
products is contributing to a serious public health problem that is an
extremely critical
[[Page 38644]]
issue requiring further action at the Federal level. The comment added
that the OTC marketing status and broad distribution of these products
is hindering efforts to prevent this illicit use of ephedrine and urged
the Committees to restrict the OTC availability of this ingredient.
The agency has also received comments from county, State, and
Federal Government organizations; pharmacists' associations; and
consumers who object to the continued marketing of OTC ephedrine drug
products because some manufacturers are promoting these products for
misuse as stimulant, weight control, and muscle enhancement products
(Ref. 3). The comments contended that this promotion has resulted in
extensive and extremely dangerous misuse and abuse of such products,
particularly in teenaged children.
IV. Misuse and Abuse of OTC Ephedrine Drug Products-
The agency has received a number of reports (Ref. 4) of young
people abusing OTC ephedrine drug products. In one case, nine junior
high school students took three to eight ephedrine 25 milligram (mg)
tablets for added energy and experienced rapid heart beats. One female
who took eight tablets had 200 heart beats per minute 2 hours after
taking the tablets. The student was able to purchase the ephedrine
tablets from a product display at a local convenience store without
being questioned about the reason for its use. Another report (Ref. 5)
indicated that three 15-year-old girls had consumed 24 to 33 tablets of
ephedrine-containing OTC drugs for ``kicks.''
The agency is aware of numerous other reports involving young
people who have overdosed by using OTC ephedrine products promoted as a
stimulant or for weight control, or by using such products for
recreational purposes in high doses and on a regular basis. One report
(Ref. 5) involved a 17-year-old male who died after ingesting a toxic
or lethal amount of ephedrine. The youth apparently took the ephedrine
to increase alertness, strength, and physical stamina. In another case
(Ref. 4), a 21-year-old female developed respiratory problems (trouble
breathing) after taking three to four 25 mg ephedrine tablets,
purchased OTC, every other hour (and then every hour) over an 8-hour
period and consuming alcoholic beverages. Hospitalization resulted from
this recreational use of ephedrine.
In another case (Ref. 4), a 22-year-old female took OTC ephedrine
tablets because her friends had told her they would act as ``uppers.''
The woman's job required her to work long hours, and she felt she
needed a chemical pick-up to get through the day. She presented to a
hospital emergency room with headache, nausea, anxiety, and blood
pressure of 170/110 millimeters mercury. She was treated, with no
permanent adverse effects.
FDA's Spontaneous Reporting System also contains a number of
reports of ephedrine misuse and abuse (Ref. 4), some of which have
resulted in death due to an overdose of ephedrine. In one case, a 52-
year-old male took 10 to 15 ephedrine tablets (believed to be 50 mg)
over the previous 24 hours. In another case, a 24-year-old male who
died of an overdose had a blood level of ephedrine over 30 times the
usual therapeutic range. In another overdose case, the reporting
pharmacist commented that ``ephedrine is becoming a drug for abuse--
would recommend to withdraw OTC status.'' In another case, the
reporting hospital pharmacist noted that the ephedrine overdose (in a
19-year-old female) was the second incident observed this year for
these ephedrine/caffeine products sold at convenience markets and ``not
FDA regulated.''
Interested consumers and state regulatory officials (e.g., health
departments, boards of pharmacy) have expressed concern about OTC
ephedrine drug products being sold under brand names that reflect a use
other than as a bronchodilator (e.g., use as a stimulant or for weight
control); about products being readily available at convenience stores,
truck stops, gas stations, and mini-marts with little, or no,
restriction on their sale; and about products being purchased and used
by children and adolescents, on an ever increasing basis, with a
continuing increase in the number of reported adverse events.
One director of an addictions program informed FDA (Ref. 6) that
his locality (in Indiana) is experiencing a surge of adverse responses
or reactions to the use of OTC ephedrine being abused for its stimulant
effect. He reported that a number of people abusing ephedrine have
demonstrated stimulant dependence characterized by compulsion,
obsession, or preoccupation, and that ephedrine abuse has induced or
worsened mental disorders such as depressive anxiety and different
thought disorders. He stated that people are obtaining the drug OTC as
ephedrine (not in combination with other drugs) under different brand
names, some of which are advertised as an ``energizer.'' He mentioned
that the age group abusing ephedrine ranges from teenagers to people
who are in their 40's.
A nurse reported her daughter's adverse experience with an OTC
ephedrine product (Ref. 4) and mentioned that within the last year the
child's pediatrician had treated several adolescents who had overdosed
on ephedrine. The nurse added that many emergency room physicians are
seeing behavior similar to schizophrenia occurring in young adults as a
result of ephedrine obtained OTC. The nurse questioned why this drug
was readily purchasable by unsuspecting teenagers.
The agency concludes that these reports show that OTC ephedrine
drug products are marketed in ways that are misleading, that promote
misuse and abuse, and that can be dangerous. The agency believes that
these reports represent only a small percentage of the actual number of
adverse events that have occurred and that ephedrine misuse and abuse
are a widespread problem in the United States.
According to one source (Ref. 7), at least 14 states have placed
additional controls and restrictions on ephedrine to address the abuse
problem. These controls include, in at least five states (Florida,
Idaho, New Mexico, Oregon, and Washington), switching the products to
prescription only status. In Michigan, possession of more than 4 grams
of ephedrine requires a prescription. Six states (Arizona, Missouri,
Nevada, Ohio, Oklahoma, and Wisconsin) have scheduled ephedrine as a
controlled substance. The agency is aware that Kentucky, Massachusetts,
and Virginia have introduced bills to tighten ephedrine controls and
that other states are also considering similar actions.
The agency concludes that the misuse and abuse of OTC ephedrine
drug products have the potential for causing harm as shown by the many
reports submitted to the agency. FDA has determined that action is
needed to eliminate this misuse/abuse potential. FDA's proposed action,
when finalized, will eliminate the need for future action by individual
states.
V. Advisory Committee Comments
At a meeting of FDA's Pulmonary-Allergy Drugs Advisory Committee
and Nonprescription Drugs Advisory Committee (the Committee) held on
November 14, 1994, the Committee members heard presentations from
private citizens and state officials concerning the misuse and abuse of
OTC ephedrine drug products (Ref. 8). The Committee members expressed
concern about the reports of abuse and illicit diversion of ephedrine.
One Committee member mentioned that removal of ephedrine from the OTC
[[Page 38645]]
marketplace by FDA or DEA regulatory action would cause no harm and,
indeed, would do some amount of good. Although the Committee did not
hear from manufacturers of OTC ephedrine drug products and was not
asked the specific question whether these products should be removed
from the OTC market, there was a consensus that the benefit of OTC
ephedrine does not justify its continued use as an OTC bronchodilator
active ingredient when the potential for illicit use and misuse is
considered (Ref. 9).
FDA received comments from manufacturers in response to the notice
for the Committee meeting (59 FR 34847, July 7, 1994). Two
manufacturers opposed the marketing of any OTC bronchodilator drug
product (Ref. 10). One manufacturer submitted a ``Profile of Asthma
Sufferers and Users of Nonprescription Epinephrine (Mist) and Ephedrine
Combination (Tablets)'' in support of its position these drug products
remain available OTC (Ref. 11). Another manufacturer supported the
continued marketing of legitimate OTC ephedrine-containing
bronchodilator drug products (Ref. 12). This manufacturer briefly
discussed the abuse potential for single ingredient ephedrine-
containing products, particularly those that are deliberately labeled
to imply nonmonographed usage. The manufacturer stated that the extent
of any abuse is unclear and potentially exaggerated by a small number
of highly publicized abuse instances. The comment noted that a number
of states have enacted legislation to discourage abuse, in response to
this situation. The comment mentioned that most states have generally
made provisions to ensure continued OTC availability of legitimate
combination asthma products, such as its product containing ephedrine
sulfate and guaifenesin, an expectorant.-
The agency has considered the manufacturers' views in developing
this proposal. As discussed above, the agency believes that the misuse/
abuse problem is widespread and much broader than one manufacturer
suggested. Continued OTC availability of combination products
containing ephedrine and guaifenesin would not alleviate this problem.
Large quantities of guaifenesin are generally safe, and the combination
product would not stop people from taking large amounts for the effects
of the ephedrine. Further, DEA has informed FDA that it is aware that
ephedrine can readily be isolated from such combinations for illicit
manufacture (Ref. 13). Accordingly, FDA concludes that the best
resolution for this misuse/abuse problem is for ephedrine, singly or in
combination products, not to be available OTC.
VI. References-
The following references are 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) Correspondence in OTC Vol. 04BPEA, Docket No. 95N-0205,
Dockets Management Branch.
(2) Comment No. C6, Docket No. 94N-0232, Dockets Management
Branch.
(3) Comments No. C5, C6, C10, C11, C12, C17, C19, C20, APE8,
APE10, APE13, and LET142, Docket No. 94N-0232, Dockets Management
Branch.
(4) Adverse reaction reports in OTC Vol. 04BPEA, Docket No. 95N-
0205, Dockets Management Branch.
(5)-Comment No. C10, Docket No. 94N-0232, Dockets Management
Branch.---
(6)-Letter from B. B. Rohrer, The Addictions Program, to FDA,
dated June 24, 1993, in OTC Vol. 04BPEA, Docket No. 95N-0205,
Dockets Management Branch.
(7)-National Association of Boards of Pharmacy Foundation, Inc.
Newsletter, October 1994, pp. 2-3, in OTC Vol. 04BPEA, Docket No.
95N-0205, Dockets Management Branch.---
(8)-Transcript of a Joint Meeting of the Pulmonary-Allergy Drugs
Advisory Committee and the Nonprescription Drugs Advisory Committee,
November 14, 1994, pp. 56-84, in OTC Vol. 04BPEA, Docket No. 95N-
0205, Dockets Management Branch.---
(9)-Transcript of a Joint Meeting of the Pulmonary-Allergy Drugs
Advisory Committee and the Nonprescription Drugs Advisory Committee,
November 14, 1994, pp. 235, 236, 258, 259, 264, 265, 270, 271, and
272, in OTC Vol. 04BPEA, Docket No. 95N-0205, Dockets Management
Branch.
(10) Comments No. C8, APE1, and C11, Docket No. 94N-0232,
Dockets Management Branch.
(11) Comment No. LET144, Docket No. 94N-0232, Dockets Management
Branch.
(12) Comment No. C18, Docket No. 94N-0232, Dockets Management
Branch.
(13) Memorandum of a telephone conversation between D. Snyder,
DEA, and G. Rachanow, FDA, dated April 20, 1994, in OTC Vol. 04BPEA,
Docket No. 95N-0205, Dockets Management Branch.
VII. Summary of the Agency's Proposed Change
The agency is proposing that ephedrine, ephedrine hydrochloride,
ephedrine sulfate, and racephedrine hydrochloride 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 due to their
widespread and easy availability as an OTC drug. This proposed
amendment removes the ingredients ephedrine, ephedrine hydrochloride,
ephedrine sulfate, and racephedrine hydrochloride from the final
monograph for OTC bronchodilator drug products (21 CFR part 341). It
does not affect the monograph status of epinephrine-containing drug
products when used in a hand-held rubber bulb nebulizer. Such products
will remain in the final monograph for OTC bronchodilator drug
products.
This proposal would remove all oral systemically acting
bronchodilator drug products from the OTC market. Thus, the agency is
proposing to amend Sec. 341.16 of the final monograph for OTC
bronchodilator drug products to remove Sec. Sec. 341.16(a), (b), (c),
and (f) for ephedrine ingredients and to redesignate Sec. 341.16(d),
(e), and (g) as Sec. 341.16(a), (b), and (c), respectively. Also, the
agency is proposing to amend Sec. 341.76(c) to remove paragraph (5), to
revise the heading for paragraph (6), and to redesignate paragraphs
(6)(i), (6)(ii), and (6)(iii) as paragraphs (5)(i), (5)(ii), and
(5)(iii), respectively. In addition, the agency is proposing to amend
Sec. 341.76(d) to remove paragraph (1), to redesignate paragraph (2) as
paragraph (1), to revise the heading in new paragraph (1), and to
reserve paragraph (2). The agency is also proposing to amend
Sec. 341.90 by removing paragraph (a) that pertains to ephedrine and
redesignating paragraphs (b) through (q) as paragraphs (a) through (p),
respectively. Furthermore, the agency is proposing to amend the list of
ingredients that are not generally recognized as safe and effective for
specified uses in Sec. 310.545 (21 CFR 310.545) by adding new
paragraphs (a)(6)(iv)(D) and (d)(27) for ephedrine preparations.
VIII. 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
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options that would minimize any significant impact of a rule on small
entities. This rule would eventually stop the marketing of OTC
bronchodilator drug products containing ephedrine, ephedrine
hydrochloride, ephedrine sulfate, or racephedrine hydrochloride. The
agency has determined that legitimate drug manufacturers have little or
no interest in single ingredient OTC ephedrine drug products. However,
some manufacturers may have an interest in combination drug products
containing ephedrine.
The agency acknowledges that this proposed rule, if finalized,
would have an impact on consumers who legitimately use OTC
bronchodilator drug products containing ephedrine to relieve their
bronchial asthma. They will no longer be able to purchase these
products without a doctor's prescription. However, all OTC
bronchodilator drug products must bear a label warning that states ``Do
not use this product unless a diagnosis of asthma has been made by a
doctor.'' Therefore, it is presumed that legitimate users of these
products have seen a doctor and are under a doctor's occasional care
for the treatment of their asthma. These consumers will be able to
obtain an ephedrine drug product upon a doctor's prescription if the
doctor determines that ephedrine is the drug that should be used to
treat the condition. These consumers will also be able to purchase OTC
epinephrine for inhalation to treat their bronchial asthma without a
doctor's prescription. At its November 14, 1994, meeting, the Committee
recommended that epinephrine for inhalation remain available OTC for
self-treatment of asthma under certain conditions. The agency has
weighed the consequences of this proposed rule as it might adversely
impact some legitimate users of these OTC ephedrine drug products.
However, these consumers will have access to another drug without a
prescription and could continue to obtain ephedrine products on a
doctor's prescription. The agency has determined that as a result of
the widespread misuse and abuse of OTC ephedrine drug products,
especially by many young people and people up to in their 40's, that it
is in the best interest of all consumers (especially parents) to remove
from the OTC market ingredients that are used extensively in the
manufacture of illicit drugs and that have widespread misuse and abuse
with the potential to cause harm. Further, the agency is not aware of a
widespread marketing of legitimate OTC bronchodilator drug products
containing ephedrine, although several manufacturers could be adversely
affected by this proposed rule. 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 OTC
bronchodilator drug products that contain ephedrine, ephedrine
hydrochloride, ephedrine sulfate, or racephedrine hydrochloride.
Comments regarding the impact of this rulemaking on these drug products
should be accompanied by appropriate documentation. A period of 30 days
from the date of publication of this proposed rulemaking in the Federal
Register will be provided for development and submission of comments on
this subject. Because of the existing serious public health problem
identified by DEA and a number of states, and the many reports of
misuse and abuse of OTC ephedrine drug products that FDA has received,
the Commissioner has determined that there is good cause for a
shortened comment period. FDA 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.
IX. Environmental Impact
The agency has determined that 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 nor an environmental impact statement is
required.
Interested persons may, on or before August 28, 1995, submit to the
Dockets Management Branch (address above) written comments or
objections regarding this proposal. Written comments on the agency's
economic impact determination may be submitted on or before August 28,
1995. Three copies of all comments or objections are to be submitted,
except that individuals may submit one copy. Comments and objections
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. Comments and objections may be seen in the office
above between 9 a.m. and 4 p.m., Monday through Friday.
List of Subjects
21 CFR Part 310
Administrative practice and procedure, Drugs, Labeling, Medical
devices, Reporting and recordkeeping requirements.
21 CFR Part 341
Labeling, 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 310 and 341 be 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).
2. Section 310.545 is amended by adding new paragraphs
(a)(6)(iv)(D) and (d)(27) and by revising paragraph (d) introductory
text to read as follows:
Sec. 310.545 Drug products containing certain active ingredients
offered over-the-counter (OTC) for certain uses.
(a) * * *
(6) * * *
(iv) Bronchodilator drug products. * * *
(D) Approved as of August 28, 1995.
Ephedrine
Ephedrine hydrochloride
Ephedrine sulfate
Racephedrine hydrochloride
* * * * *
(d) Any OTC drug product that is not in compliance with this
section is subject to regulatory action if initially introduced or
initially delivered for introduction into interstate commerce after the
dates specified in paragraphs (d)(1) through (d)(27) of this section.
* * * * *
(27) August 28, 1995, for products subject to paragraph
(a)(6)(iv)(D) of this section.
PART 341--COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC
DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
3. The authority citation for 21 CFR part 341 continues to read as
follows:
Authority: Secs. 201, 501, 502, 503, 505, 510, 701 of the
Federal Food, Drug, and
[[Page 38647]]
Cosmetic Act (21 U.S.C. 321, 351, 352, 353, 355, 360, 371).
Sec. 341.16 [Amended]
4. Section 341.16 Bronchodilator active ingredients is amended by
removing paragraphs (a), (b), (c), and (f) and by redesignating
paragraphs (d), (e), and (g) as paragraphs (a), (b), and (c),
respectively.
5. Section 341.76 is amended by removing paragraph (c)(5);
redesignating paragraph (c)(6) as paragraph (c)(5); and revising the
heading for newly redesignated paragraph (c)(5); by removing paragraph
(d)(1); by redesignating paragraph (d)(2) as paragraph (d)(1); by
reserving paragraph (d)(2); and by revising the heading in newly
redesignated paragraph (d)(1) to read as follows:
Sec. 341.76 Labeling of bronchodilator drug products.
* * * * *
(c) * * *
(5) For products containing epinephrine, epinephrine bitartrate, or
racepinephrine hydrochloride identified in Sec. 341.16(a), (b), and
(c). * * *
* * * * *
(d) * * *
(1) For products containing epinephrine, epinephrine bitartrate, or
racepinephrine hydrochloride identified in Sec. 341.16(a), (b), and
(c). * * *
(2) [Reserved]
* * * * *
Sec. 341.90 [Amended]
7. Section 341.90 Professional labeling is amended by removing
paragraph (a) and redesignating paragraphs (b) through (q) as
paragraphs (a) through (p), respectively.
Dated: July 5, 1995.
William K. Hubbard,
Acting Deputy Commissioner for Policy.
[FR Doc. 95-18448 Filed 7-26-95; 8:45 am]
BILLING CODE 4160-01-F
