In this issue: The National Formulary (NF)

Covered in last week's Newsletter:

How and Why the United States Pharmacopeia was Created

Planning for the first USP

First Published USP

Preface to the First USP

Revision Every 10 Years, then Every 5 Years

Physicians and Pharmacists Involved

In This Issue

When the American Pharmaceutical Association (APhA) was organized in 1852, the only authoritative and recognized book of drug standards available was the third revision of the United States Pharmacopeia (USP). To serve as a therapeutic guide to the medical profession, its scope, then as now, was restricted to drugs of established therapeutic merit. Because of strict selectivity, many drugs and formulas that were accepted and used by the medical profession were not granted admission to early revisions of the USP. As a type of protest, and in keeping with the original objectives of the APhA to standardize drugs and formulas, certain pharmacists, with the sanction of their national organization, prepared a formulary containing many of the popular drugs and formulas denied admission to the USP. The first edition was published in 1888 under the title National Formulary of Unofficial Preparations. The designation "unofficial preparations" reflected the protest mood of the authors because the USP had earlier adopted the term "official" as applying to the drugs for which it provided standards. The title was changed to National Formulary (NF) on June 30, 1906, when President Theodore Roosevelt signed into law the first federal Pure Food and Drug Act, designating both the USP and NF as establishing legal standards for medicinal and pharmaceutical substances. Thus, the two publications became official compendia. Among other things, the law required that whenever the designation USP or NF was used or implied on drug labeling, the products must conform to the physical and chemical standards set forth in the compendium monograph.

USP Purchases the National Formulary from APhA in 1975.

The early editions of the NF served mainly as a convenience to practicing pharmacists by providing uniform names of drugs and preparations and working directions for the small-scale manufacture of popular pharmaceutical preparations prescribed by physicians. Before 1940, the NF, like the USP, was revised every 10 years. After that date, new editions appeared every 5 years, with supplements issued periodically as necessary. In 1975, the United States Pharmacopeial Convention, Inc. purchased the NF, unifying the official compendia and providing the mechanism for a single, national compendium.

Today, the United States Pharmacopeia-National Formulary (USP-NF) is "continuously" revised. Revisions are available annually in hard copy and as online editions, including twice-yearly supplements and update notices on the USP's Website. Monographs for drug substances, dietary supplements, dosage forms, and compounded preparations are contained in the USP sections of the combined compendium, whereas monographs for pharmaceutical excipients are contained in the NF section.

The standards advanced by the USP and the NF are put to active use by all members of the healthcare industry who share the responsibility and enjoy the public's trust for ensuring the availability of quality drugs and pharmaceutical products and preparations. The USP-NF is used by pharmacists, physicians, dentists, veterinarians, nurses, producers, and suppliers of bulk chemicals for use in drug production; large and small manufacturers of pharmaceutical products; drug procurement officers of various private and public health agencies and institutions; drug regulatory and enforcement agencies; and others.

The USP-NF consists of drug substance monographs, drug product monographs, compounding monographs, excipient monographs, dietary substance monographs, general chapters, and supportive information. The General Chapters are divided into those that are enforceable (numbered <1000 of which there are approximately 200) and those that are informational (numbered >1000 of which there are approximately 180). As the USP has no enforcement powers, it is dependent upon the FDA and the individual State Boards of Pharmacy for acceptance and enforcement of its standards. It should be noted that these are "standards" and not regulations or laws. Not all State Boards of Pharmacy have adopted the chapters specifically related to compounding and to the handling of hazardous drugs but have developed their own individual state standards for enforcement.

Next week, Overall Composition of the USP-NF

Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition

Did You Know (On Succeeding and Failing) ...The following?

...the following?

"Bizet, the great composer, died at the age of thirty-seven, broken-hearted over the supposed failure of his opera Carmen."

"A guest on a golf course placed the ball in position, and missed it three times, and hit it the fourth time, and then turned to his host and said:" 'This is a difficult course, isn't it?'"

Join the CNL!

IJPC would like to invite all compounding pharmacists and technicians to join the Compounders' Network List (CNL) - an e-mail-based resource for sharing compounding information with your peers.

Go to the following website for more information and to join.

https://ijpc.com/cnl

From Out of the Past

His rose is wed
His violet blew
But his sugar is sweet
Since he took his cue
     Burma-Shave