Drug and Chemical

Standards
 The United States
Pharmacopeia and The
National Formulary
 • The term pharmacopeia comes from
the Greek “pharmakon” meaning drug
and “poiein” meaning “make”.
• The combination indicates any recipe
Pharmacopeia or formula or others standards
required to make or prepare a drug.
• It is a valuable uniform set of national
drug standards.
• In the US, drug standards were provided on
a national basis in 1820 when the first USP
was published.
• But before the USP was published, the first
American pharmacopeia was the Lititz
Pharmacopeia published at Lititz,
Pennyslvania for use by the Military
Hospital of the US army. It contained
information on 84 internal and external
drug preparations
• On January 6, 1817, Lyman Spalding, a
physician from NY, submitted a plan to the
Medical Society of the County of New York
for the creation of a national Pharmacopeia.
Spalding’s efforts were later to result in his
being recognized as the Father of the United
States Pharmacopeia.
• Draft pharmacopeias were submitted to the
convention, these were reviewed,
consolidated and adopted by the first United
States Pharmacopeial Convention
assembled in Washington, DC.
• The first USP was published on December
15, 1820, in English and Latin.
Objective of the first USP

• It is the object of a Pharmacopeia to select from among substances,

which possess medicinal power. those, the utility of which is most fully
established and best understood; and to form from them preparations
and compositions, In which their powers may be exerted to the greatest
advantage. It should likewise distinguish those articles by convenient
and definite names, such as may prevent trouble or uncertainty in the
intercourse of physicians and apothecaries.
Revisions of the USP
• The first provisions necessitated a convention to produce a revised
USP every 10 years
• It also granted authority to issue supplements to the USP whenever
necessary to maintain satisfactory standards
• In the 1940 meeting of the convention, it was decided to revise the
USP every 5 years while maintaining the use of periodic supplements.
National Formulary
• When the American Pharmaceutical Association was
organized in 1852, the only authoritative and recognized
book of drug standards was the USP.
• To serve as the therapeutic guide to the medical profession,
its scope then and 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 into the 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, prepared
a formula containing many of the popular drugs and formulas denied
admission of the USP.
• The first edition was published under the titles National Formula of
Unofficial Preparations.
• The title changed to National Formulary (NF) on June 30, 1906 when
President Theodor Roosevelt signed into law the first federal Pure Food
and Drug Act, designating both the USP and NF as establishing legal
standards for medical and pharmaceutical substances.
• Thus the two publications became official compendia.
• The law required that whenever the designation USP or NF was used in
labeling it must conform to the physical and chemical standards set
forth by the monograph.
• The early editions of 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
Epinephrine,
USP
Combination of USP and NF
• In 1975, the United States Pharmacopeial convention, Inc. purchased
the NF, unifying the official compendia and providing the mechanism
for a single national compendium
• The first national Compendium, composed of USP XX and NF XV,
became official on July 1, 1980.
CURRENT as
of NOV 1,
2020: USP 43
and NF 38
Magkano?
USP General Chapters

• USP Chapter <795> Pharmaceutical Compounding-Nonsterile Preparations

• USP Chapter <797> Pharmaceutical Compounding-Sterile Preparations
• USP Chapter <800> Hazardous Drugs-Handling in Health Care Settings
• USP <1160> Pharmaceutical Calculations in Pharmacy Practice
• USP <1163> Quality Assurance in Pharmaceutical Compounding
 • Homeopathic Pharmacopeia of the United
Other States (HPUS)
• International Pharmacopeia (IP)
Pharmacopeias • European Pharmacopeia (EP or Ph Eur)
• British Pharmacopeia (BP)
• Japanese Pharmacopeia (JP)
• Philippine Pharmacopeia (PP)
Ingredient
Standards
Ingredient Standards

Throughout history, pharmacists have used chemicals and other materials for
prescription compounding. In the past these chemicals and materials were
obtained from natural preparations, raw materials and household ingredients.

Today, Compounding Pharmacists use chemicals from various sources,

depending on availability.
Quality of Ingredients

• USP Chapter 795 states that “The pharmacist is responsible for

compounding preparations of acceptable strength, quality and purity with
appropriate packaging and labeling in accordance with good pharmacy
practices, official standards, and relevant scientific data and information.
• The compounding of quality preparations must involve the use of high-
quality chemicals. If USP/NF grade materials are used to prepare
compounded formulations, the preparation must meet the requirements
of compendial monographs.
Description of Chemical Grades

• USP/NF – Meets the minimum purity standards, conforms to tolerances set

by the USP/NF for contaminants dangerous to health
• ACS reagent – High purity, conforms to minimum specifications set by the
Reagent of Chemicals Committee of the American Chemical Society
• CP (chemically pure) – More refined than technical or commercial grade
but still of unknown quality.
• Technical or Commercial – Indeterminate Quality
• Analytical Reagent – High purity low contaminant grade reagents used in
quantitative analysis.
• FCC – Food Chemicals Codex grade – Conforms to the standards set by FCC.
• HPLC grade – Reagent to be used in HPLC experiments
• Spectroscopic grade
• Primary standards
 • Remington : Art and Science of Pharmacy
Reference • Ansel’s Pharmaceutical Dosage Forms and
Library for Drug Delivery Systems
compounding • Pharmaceutical Calculations by Ansel
• AHFS Drug information
non-sterile • Merck Index
preparations • Martindale: The extra Pharmacopeia
• Handbook of Pharmaceutical Excipients
• Applied Pharmaceutics in Contemporary
Compounding