![handle is hein.journals/fdliup1996 and id is 1 raw text is: Promoting an Understanding of
e Laws, Regulations, and
licies Affecting the Public
cal, Aspects of Foods - Drugs
- Cosmetics - Medical Devices-
Biological Products - and
Veterinary Medical Products
JAN.IFEB.
1996
The Food and Drug Law Institute
UPD
Regulation
*0
A
Law
Inside
Hutt Receives
Service Award ...............
Codex Plays
International Role ........
FDLI Info Series-
Part I ..............................
Ssecutions for
ood & Drug Violations
May Increase.................
Every Iss
On the Move .................
Member Profiles...........
New Books ....................
Speci
Picture Perfect: FDLI's
Annual Meeting ............
Pioneering Harmonization
U.S. Pharmacopeia a Leader in Standards Setting
-Andrea L. Panico
Imag ine. You are living in the United States in the early nineteenth century. There is no
pharmaceutical industry. Pharmaceuticals, in fact, are natural medicines-derivatives of veg-
etable, mineral, and animal products-and are made by the physicians who prescribe them. The
apothecaries who occasionally assist have been trained not in the United States, where schools of
pharmacy do not yet exist, but in London or Edinburgh.
You are diagnosed with a heart condition. Your doctor prescribes digitalis tincture. You move to a
different city and your new doctor, after examining you, prescribes digitalis as well. But what is
digitalis? Is the digitalis your first doctor prescribed the same medicine dispensed by your second
doctor? Can you expect the two drug products to be the same?
Prior to the formation of the United States
8 Pharmacopeia (USP) in 1820, such a therapeutic
8 equivalence could not be expected. Fortunately,
physicians recognized that a pharmacopeia was
necessary to standardize the identity, strength,
purity, and quality composition of drugs and their
In products. USP was created with that goal in
mind.
ue Preceding the formation of the American
Medical Association (1847) and for its first
..5 thirty years, USP consisted mostly of physicians.
But in 1850, pharmacists were officially added
..7 to the USP membership, bringing analytical
ability and the knowledge of how to create drug
11 products, skills that complemented the strengths
of the founding physicians.
Today, that biprofessionalism has expanded
to multiprofessionalism, and anchors USP in its
175-year tradition of volunteer standard-setting
for the identity, purity, strength, quality,
al! packaging, and labeling of drugs.
The United States Pharmacopeia (USP) is
the only pharmacopeia not issued by a
government agency. For that reason, the
acceptance of USP standards into federal drug
legislation, starting with its inclusion in the Drug
Import Act of 1848, is especially significant.
In a recent interview, USP's Executive Vice
..3 President, Jerome A. Halperin, commented, It
is significant that [USP]'s standards have been
adopted, accepted and included in federal drug
legislation in the United States for almost 150
years, well in advance of a government drug
regulatory program.
New drugs are constantly being introduced
into the market, and old drugs, on occasion,
require review. But the need to set standards and
have them adopted does not limit the scope of
USP's activity. Over the years, the needs of health
care professionals and the public have been the
impetus for the organization to refine its focus.
USP's incorporation of the National
Formulary (NF) in 1975 illustrates this refining
process. Prior to 1975, USP set standards only
for those drugs most fully established and best
understood. But physicians and pharmacists
were using other drugs, and those drugs needed
standards, as well. The National Formulary
became the body that set standards for drugs that
did not meet the criteria of most fully established
and best understood. Combined, the USP and
the NF provided standards for all drugs.
Today the standards for active drug
substances and products are found in the USP;
the standards for excipients are found in the NF.
Our goal is to have standards for all drugs on
the American market, Halperin notes.
Operationally, 'all drugs' is interpreted as at least
Continued on page 10
Digitized from Best Copy Available
*TE
Education
2
4
6](ViewImageLocal?handle=hein.journals/fdliup1996&div=1&collection=&method=preview&ext=.png&size=3)
What Is HeinOnline?
Contact us for annual subscription options:
Already a HeinOnline Subscriber?
profiles profiles most
Contact us for annual subscription options:
Already a HeinOnline Subscriber?
profiles profiles most
Contact us for annual subscription options:
Already a HeinOnline Subscriber?
profiles profiles most