Lesson 16E, EXTRA3 - Homœopathic Pharmacopœia of the United States (HPUS).
Sheri Nakken
Lesson 16E, EXTRA3 - Homœopathic Pharmacopœia of the United States (HPUS).
http://www.hpus.com
Full info at the above website
http://www.hpus.com/techbull.htm
The Regulation of Homeopathic Medicines
Since June 9, 1990, a number of changes in status
of homeopathic remedies have taken place.
Numerous remedies that were once sold as
Over-The-Counter, have moved to prescription
status. This is due to the publication of the FDA
Compliance Policy Guide 7132.15 "Conditions Under
Which Homeopathic Drugs May Be Marketed," and the
Homœopathic Pharmacopœia of the United States
(HPUS). These documents form the basis for the
regulation of homeopathic drugs in the United States.
On June 9, 1988 the first installment of the new
edition of the HPUS (now called the Homœopathic
Pharmacopœia Revision Service or HPRS) was
published. On the same date, FDA's Compliance
Policy Guide relating to the marketing of
homeopathic medicines was published. Both
documents had two year phase in dates, thus they
became "effective" in June, 1990. The fact of the
matter is that most manufacturers had phased in
the provisions of both prior to that date.
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The Compliance Policy Guide
For many years (from 1938-1988) homeopathic drugs
were sold in a regulatory vacuum. FDA action was
based on institutional understanding and informal
agreements between agency officials and industry
members. This caused the FDA to regulate in an
unpredictable manner that made the homeopathic
industry unsafe from a regulatory and investment
standpoint; and the practice of homeopathy open
to the whims of local regulators. During the
period, the FDA viewed all homeopathic remedies
as prescription drugs. From 1982-1988, the
industry, professional and consumer members of
the community through the American Homeopathic
Pharmacists Association (AHPhA) worked with the
FDA in the development of a regulatory framework
called a Compliance Policy Guide (CPG). Although
the community didn?t get every provision that it
sought, it is argued that the community obtained
about 80% of its requests. The new CPG
strengthened the definition of the homeopathic
drug, set forth guidelines for the prescription
and nonprescription drugs and made clear packaging and labeling guidelines.
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Rx and Homeopathic Medicines
The most important element was that the CPG
established that homeopathic drugs could be OTC;
setting guidelines for an OTC homeopathic drug by
saying that an OTC homeopathic was a homeopathic
drug claimed for a self limiting condition which
did not require medical diagnosis or monitoring
and was non-toxic. Further, such drugs, whether
sold on an active or reactive basis, needed to be
fully labeled with at least one indication for
use (and a package insert if Rx.) At one time,
the industry was required to drop all Latin
labeling but was able to get the regulation
rescinded. The industry was not pleased with
these restrictions, but they were better than the
worst case scenario of all homeopathic drugs
having the status of prescription products.
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Official & Non-official Homeopathic Medicines
One could appreciate the FDA's actions from their
vantage point of safety and efficacy. There was
one other thing that FDA demanded. That was that
the new Pharmacopoeia be "cleaned up" within the
guidelines. Any drug included in the HPRS would
be considered "official" and those not included
in the HPRS would be "non-official." According to
the understanding, any official drug could be
sold without any further documentation being by the manufacturer.
Non-official drugs would require the manufacturer
to produce a proving or sufficient clinical data
for the FDA to make a determination as to whether
the drug was in fact homeopathic. FDA still
reserves the right to revise their criteria for
what determines a homeopathic drug. The construct
of an official and non-official drug is one that
certainly benefits the community, although FDA
has expressed a lack of comfort with the idea.
The result was a new focus on the HPRS.
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Role of the HPCUS
The HPUS is "written" by a group of pharmacists,
physicians and lay people who meet 3-6 times a
year to review monographs (information about
specific drugs) and pharmacy procedures.
Currently, there are about 1,350 drugs in the
Pharmacopœia, 440 or so are prescription in some
potency and 20 or so are Rx. For a drug to be
included in the HPUS, it needs to have sufficient
clinical data or proving to show efficacy. The
process for review is very formal as are the
criteria for acceptance. Both Resonance and
Homeopathy Today have published extensively on
these topics. All of the Pharmacopœia's
activities are published for 90 days for public
comment in Resonance and Homeopathy Today, among
others. The decisions are finalized by the HPUS
Board of Directors. OTC/Rx status is determined
by the criteria outlined in the CPG, effectively
toxicity and OTC uses for the products, i.e. a
drug needs to be non-toxic and have an OTC
indication for it to be classed OTC. The HPRS is
a dynamic document, which can change. The changes
are published in June and December of each year.
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Licensure
It is important to note that when looking at the
distinction between OTC and Rx, one is compelled
to look at the "lowest common denominator", that
is the consumer in a natural foods store or
pharmacy, not a trained homeopath. This has
caused some problems as it relates to licensure,
as many people who are very competently trained
to use homeopathic remedies lack the license to
obtain Rx products. The new results of the
increased regulation of homeopathy is that,
whether we agree with them or not, there are now
clearly established guidelines for the
manufacturing, marketing and sale of homeopathic
medicines. When one considers that OTC
homeopathic remedies were technically illegal
prior to the Compliance Policy Guide, one can
appreciate that the OTC is indeed a mixed
blessing. On the one hand, many homeopathic
remedies are now able to be sold over the counter
without fear. Of course, there are some remedies,
which continue to be prescription items. Clearly,
this presents little difficulty for the fully
licensed medical practitioner. It is the limited
licensed practitioner that is most affected by
the regulation. Time will tell what the ultimate
impact is. Interested individuals should follow
the issue closely in the press and feed back
their ideas and comments to the HPCUS in
Washington as well as their homeopathic pharmacists.