From: [email protected] (e robson)
Newsgroups: alt.drugs
Subject: "Herbal X" (Ephedrine) FAQ, *unnofficial*
Date: Mon, 06 May 1996 08:14:25 GMT
Here, after a request or two, is info I've gathered around
the web on Ephedrine. Included are some good tips on
vitamins & amino acids that you should take to counteract
the negative effects of eph on your body.
My own advice for anyone curious is:
1) Moderation. As with all substances.
2) Start out in small doses. Ephedrine *does* increase your
heart rate and constrict blood vessels. If you are
careless and OD, you *can* have a heart attack and/or
a stroke. Don't be stupid.
3) If you like it, stock up now. It looks like the FDA's going
to outlaw the stuff as soon as it possibly can, mainly because
of the recent public discussion/hysteria about it.
Good luck, be cool.
Begin unnofficial faq
EPHEDRINE
Ephedrine is a naturally occuring central nervous system stimulant obtained
from the plant _Ephedra equisetina_. It is now also produced by chemical
synthesis, the synthetic product being marketed in the form of its salt,
ephedrine sulfate; it occurs as a white crystalline powder with a bitter
taste, soluble in water and very soluble in alcohol. Ephedrine is closely
related in structure to methamphetamine, although its CNS actions are much
less potent and also longer-acting than those of the amphetamines. Its
peripheral stimulant actions are similar to but less powerful than those of
epinephrine (also called adrenaline), a hormone produced in the body by the
adrenal glands.
Ephedrine has moderately potent bronchial muscle relaxant properties, and
therefore is used for symptomatic relief in milder cases of asthmatic
attack; it is also used to reduce the risk of acute attacks in the
treatment of chronic asthma. The typical adult dose range is 30-60 mg taken
orally, three to four times per day, in the form of tablets. Ephedrine in
the form of nose drops is also widely used to relieve nasal congestion
associated with upper respitory tract illnesses. It is also used to treat
low blood pressure, because it constricts blood vessels and stimulates
certain actions of the heart. Common side effects are qualitatively similar
to those produced by amphetamines and are generally milder. Higher doses
(overdose) can cause restlessness and anxiety, dizziness, insomnia, tremor,
rapid pulse, sweating, respiratory difficulties, confusion, hallucinations,
delerium, and (very infrequently) convulsions. The most dangerous symptoms
of overdose are abnormally high blood pressure and rapid, irregular
heartbeat. A dose of ephedrine only two to three times the theraputic
maximum can cause a significant increase in blood pressure. The elderly are
particularly sensitive to overdose, and there have been a few deaths among
such patients. Finally, a number of instances of psychosis, clinically
similar to amphetamine psychosis, have resulted from chronic high-dose
abuse; other effects of chronic abuse have not been adequately studied.
Tolerance develops to the main effects of ephedrine; however, temporary
abstinence restores sensitivity.
---------------------------------------------
Interesting point to note is that the theraputic dose maximum of 60 mg is
about 2 25mg pills (the common OTC strength), while 'dangerous' amounts
would be 4 or more of the same pills. By the way, if you're going to use
ephedrine more than once or twice, use a mail-order. The OTC prices are
outrageous: 100 pils @ 25mg each should NOT cost more than about $10.
Ephedrine is an adrenergic drug that works by stimulating alpha and beta
receptors thus causing the release of norepinephrine. Alpha and beta
receptors exist in the sympathetic nervous system, (fight or flight) and
stimulation causes increased heart rate, bronchodilation, and
vasoconstriction.
Ephedrine is the oral form of Epinephrine, or adrenaline. It was once a
commonly prescribed drug for asthma, but newer drugs in the xanthine class
have less side effects.
Ephedrine is related to pseudoephedrine which was designed as a
decongestant with less undesirable effects.
Ephedra is a Chinese herb that's been used for centuries to treat asthma.
Rather than purchasing it through mail order, you might want to ask the
local pharmicist for Ephedrine sulfate in the 100 capsule bottles as it's
much cheaper that way. Though more difficult to find, ephedrine is kept as
a 'behind-the-counter' drug. Legal to purchase without a Rx, but not put
out on display.
Ephedrine taken with caffeine is a more pleasant stimulant combination
however be aware of the warnings concerning adrenergic drugs, which you can
discuss with someone qualified and licensed to do so.
This page created by Storm
Copyright �1995 by Floersch Enterprises.
Re: ephedrine & heart rate
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[ Follow Ups ] [ Post Followup ] [ BodyBuilding Discussion Forum ]
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Posted by JOEL on March 08, 1996 at 11:20:30 PM PST:
In Reply to: Re: ephedrine & heart rate posted by Tim Cornia on February
24, 1996 at 09:20:59 PM PST:
hey man.....i wouldn't be taking that 2 or 3 times a day. you should cycle
it too...a 120 resting pulse rate is just asking for trouble---i guarantee
it.....your heart rests ONLY IN BETWEEN BEATS......THAT IS WHY EXERCISE IS
BENEFICIAL---IT LOWERS YOUR RESTING HEART RATE---IF YOU HAVEN'T HAD PRBLEMS
YET, I THINK YOU MIGHT...YOU BETTER GET A TON OF SLEEP AND ALSO I WOULD
LOWER THE DOSE FREQUENCY AND EXAMIN YOUR DIET IF FAT LOSS IS YOUR
GOAL....LET ME KNOW WHAT HAPPENS----JOEL....AT [email protected]
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Ephedrine Factoids
[Floersch Enterprises]
[Image]
My excellent book: "Drugs and the Brain" by Solomon H Snyder (a fellow
tripper) contains the following factoids about Ephedrine
Ephedrine was discovered by K. K. Chen, who was looking for a substitute
for Adrenalin as an antiathsmatic (sp?). Chen was curious about chinese
herbal medicine, in particular ma huang. He and other Lilly chemists
quickly isolated ephedrine, and verified that it widened bronchial
passages. Since Adrenalin couldn't be taken orally, and had a hell of a
side-effect :-) ephedrine seemed vastly preferable. The rarity of ma huang
quickly sent chemists scrambling for a synthetic ephedrine, and sometime in
the 30's, one of them stumbled on Amphetamine.
Amphetamine was also a bronchiodilator, and could be inhaled directly,
delivering the relief within seconds. It was marketed under the name
Benzedrine and quickly became a legal, over the counter, recreational drug.
..from a 1937 Journal of the American Medical Association "Benzedrine
Tablets were used at the department for Psychology at the University of
Minnesota to study ... effects on human thought. It was found that the
substance increased alertness... Apparently, the effect iveness of the drug
in delaying the onset of sleep has induced many University of Minnesota
students so seek the drug in local Pharmacies."
Anyhoo. Ephedrine is structurally similar to the family of Amphetamines, so
it's concievable that it could serve as a precursor. this is probably
reason enough for the Feds to clamp down on it....Stock up now.
Re: ephedrine dosage
---------------------------------------------------------------------------
From [email protected] (Aramis)
Organization University of California, San Diego
Date 29 Feb 1996 02:52:51 GMT
Newsgroups rec.drugs.misc
Message-ID <[email protected]>
References 1
---------------------------------------------------------------------------
In article <[email protected]> Rod Serling
writes:
>What is a good "interesting" dosage, in mg, of ephedrine?
Depends on body weight, tolerance from previous use, percent body
fat, and a variety of "squidgy" factrs all tied into one's personal
neurochemistry. Start at the recommended dose. If you notice that
you aren't getting the desired effects, cautiously increase the dose
in further sessions. Take plenty of time inbetween uses, to avoid
building up tolerance. That way lies addiction. Expect a mildly
unpleasant comedown, deal with it. I am not, nor do I profess to be
a doctor, nurse, pharmacist, faith healer, witch doctor, mad
scientist or neurobiologist. Anything given above that could be
construed as advice is merely my own conjecture, YMMV. Is my ass
covered yet? 8-]
Raging for the Machine,
James
Information on Ephedrine Ban
In the original proposed rule (1st notice), FDA states it intends that any
change would take effect 30 days after publication of the final rule. The
2nd notice makes a correction to the effective date, as would be published
in the Code of Federal Regulations (CFR), and the final notice extends the
comment period to September 27, 1995.
***************************************************************************
[Federal Register]
Vol. 60 No. 144 Thursday, July 27, 1995 p 38647 (Proposed Rule)
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.
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.
[Key section of document]
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 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 341.16
of the final monograph for OTC bronchodilator drug products to remove
341.16(a), (b), (c), and (f) for ephedrine ingredients and to redesignate
341.16(d), (e), and (g) as 341.16(a), (b), and (c), respectively. Also, the
agency is proposing to amend 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 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 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 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
---- page 38646 ----
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:
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).
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:
341.76 Labeling of bronchodilator drug products.
* * * * *
(c) * * *
(5) For products containing epinephrine, epinephrine bitartrate, or
racepinephrine hydrochloride identified in 341.16(a), (b), and (c).
(d) * * *
(1) For products containing epinephrine, epinephrine bitartrate, or
racepinephrine hydrochloride identified in 341.16(a), (b), and (c). * * *
(2) [Reserved]
* * * * *
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
****************************************************************************
[Federal Register]
Vol. 60 No. 161 Monday, August 21, 1995 p 43421 (Proposed Rule)
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; Correction
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of proposed rulemaking; correction.
SUMMARY: The Food and Drug Administration (FDA) is correcting a proposal
that appeared in the Federal Register of July 27, 1995 (60 FR 38643). That
document proposed 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. The document was published with two errors. This
document corrects those errors.
FOR FURTHER INFORMATION CONTACT: LaJuana D. Caldwell, Office of Policy
(HF-27), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD
20857, 301-443-2994.
SUPPLEMENTARY INFORMATION: In FR Doc. 95-18448, appearing on page 38643 in
the Federal Register of July 27, 1995, the following corrections are made:
310.545 [Corrected]
1. On page 38646, in the third column, in 310.545 Drug products containing
certain active ingredients offered over- the-counter (OTC) for certain
uses, in paragraph (a)(6)(iv)(D), the words ``August 28, 1995'' are
corrected to read ``(date 30 days after date of publication of the final
rule)''; and in paragraph (d)(27), the words ``August 28, 1995'' are
corrected to read ``(Date 30 days after date of publication of the final
rule)''.
Dated: August 14, 1995.
William K. Hubbard,
Acting Deputy Commissioner for Policy.
[FR Doc. 95-20607 Filed 8-18-95; 8:45 am]
BILLING CODE 4160-01-F
****************************************************************************
[Federal Register]
Vol. 60 No. 167 Tuesday, August 29, 1995 p 44788 (Proposed Rule)
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; Extension of Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of proposed rulemaking; extension of comment period.
SUMMARY: The Food and Drug Administration (FDA) is extending to September
27, 1995, the period for comments for the notice of proposed rulemaking to
amend the monograph for over-the-counter (OTC) bronchodilator drug products
that was published in the Federal Register of July 27, 1995. That document
proposed to remove the ingredients ephedrine, ephedrine hydrochloride,
ephedrine sulfate, and racephedrine hydrochloride from the final monograph
for OTC bronchodilator drug products and to classify these ingredients as
not generally recognized as safe and effective for OTC use. FDA is taking
this action in response to several requests to extend the period for
comments to allow interested persons adequate time to assess and respond to
the proposal.
DATES: Written comments by September 27, 1995.
ADDRESSES: Submit 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-810), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-594-5000.
SUPPLEMENTARY INFORMATION: In the Federal Register of July 27, 1995 (60 FR
38643), FDA published a notice of proposed rulemaking to amend the final
monograph for 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. Interested persons were given until
August 28, 1995 to submit comments on the proposal.
In the proposal, the agency indicated that these ingredients 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. This proposed
amendment to the monograph, if finalized, would remove these ingredients
from the OTC market whether present as single ingredient products or in
combination with other cough-cold ingredients.
FDA has received requests from a manufacturers' association and two
manufacturers of OTC bronchodilator drug products to extend the comment
period until October 27, 1995, to permit adequate development of comments
by industry and other interested parties. The requests stated that the
extension is necessary because of the summer vacation season and the
inability to develop a responsive submission in 30 days as provided in the
proposed monograph amendment.
One comment indicated that FDA's action could set a precedent for the
agency to take action later concerning OTC drug products containing
pseudoephedrine and phenylpropanolamine, which are also included in the
Domestic Chemical Diversion Control Act of 1993 as �listed chemicals� used
as precursors in the clandestine manufacture of methamphetamine and
metcathinone. The comment added that because the proposed amendment to the
monograph could have profound implication on the entire OTC drug industry,
additional time to comment is necessary to evaluate the legal and policy
implications for companies who make products containing pseudoephedrine
and/or phenylpropanolamine.
FDA emphasizes that this proposal affects ephedrine ingredients only. The
proposed amendment does not affect the current OTC marketing status of
pseudoephedrine or phenylpropanolamine in any manner. However, because of
the comment's concerns that the proposal may have a potential future impact
on the OTC drug industry, the agency wants to allow additional time for
interested persons and manufacturers to more fully express their views.
However, because of the continuing misuse and abuse of OTC ephedrine drug
products, the agency has determined that the additional period shall be 30
days only. Therefore, the agency is providing an extension of the period
for comments until September 27, 1995.
Interested persons may, on or before September 27, 1995, submit to the
Dockets Management Branch (address above) written comments on the proposed
monograph amendment.
---- page 44788 ----
Three copies of any 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. Received comments may be
seen in the office above between 9 a.m. and 4 p.m., Monday through Friday.
Dated: August 24, 1995.
Ronald G. Chesemore,
Associate Commissioner for Regulatory Affairs.
[FR Doc. 95-21480 Filed 8-25-95; 11:05 am]
BILLING CODE 4160-01-F
[End of Document]
Thanks to Rick Raske ([email protected]) for providing me with this
valuable information.
