L2 - Drug reff & part of usp

GENERAL NOTICES SECTION

The section that presents the basic assumption, definitions, and default conditions for the interpretation and application of the United States Pharmacopeia (UP) and the National Formulary (NF)

GENERAL CHAPTERS

 Contains descriptions of tests and procedures for application through individual monographs

1 to 999

Physical TESTS and determinations, microbiological test, chemical tests and assays, biological tests and assays ▪ ENFORCEABLE

1000 to 1999

GENERAL INFORMATION (no mandatory requirement)

Above 2000

Apply to articles classified as DIETARY INGREDIENT OR SUPPLEMENTS

< 621 >

CHROMATOGRAPHY

< 1174>

POWER FLOW

< 2021>

Microbial Enumeration Test - Nutritional and Dietart Supplements

MONOGRAPH

• API and FPP 

• Provides a specification by way of a name, definition, description, test, procedures, and acceptance criteria, and sometimes packaging and labeling requirements

OFFICIAL COMPENDIA

• Approved sources of guidelines for drug quality required by certain practitioners or agencies 

PHARMACOPEIA

• the word derives from the ancient Greek φαρμακοποιΐα (pharmakopoiia) - φαρμακο- (pharmako-) ′′drug′′ – ποι- (poi-) ′′make′′ – ια (-ia). - ′drug-mak-ing′′ or ′′TO MAKE A DRUG′′ 

• It comprises LIST of pharmaceutical substances, formula along with their description and standards

1996

CREATION: first Philippine Pharmacopeia in cooperation with the Japanese Government through the initiatives of Dr. Conrado S Dayrit and Prof Akira Hamada.

1999

CREATION: Pharmacopeia Organization for the preparation and publication of the Phil Pharmacopeia through Department Order No. 216

216

1999

CREATION: Pharmacopeia Organization for the preparation and publication of the Phil Pharmacopeia through Department Order No. ??

2004

• Exec. Order 302 

• Declaring and adopting the Phil Pharmacopeia as the Official book of Standards and Reference For Pharmaceutical Products and Crude plant drugs in the Philippines (Mar 29, 2004)

302

2004

WHAT Exec. Order  

1864

Medical Act of 1858 published the first combined Pharmacopeia (London, Edinburgh and Dublin)

2007

BP edition included monographs of materials used for Traditional Chinese medicine

2008 - Present

• present Edition and thereafter 

• Revision is annual and is made official every 1st of January each year

1st of January each year

                         BRITISH  PHARMACOPEIA

2008 - present

Revision is annual and is made official every ??

JUNE 25, 1886

• JAPAN Pharmacopoeia was first published

1951

• INDIAN Pharmacopoeia was published by WHO in cooperation with the United Nations

1969

• EUROPEAN Pharmacopoeia was published

Lititz Pharmacopeia

FIRST PHARMACOPEIA in the US

Gen William Brown

Lititz Pharmacopeia COMPILED:

Lititz, Pennsylvania,

Lititz Pharmacopeia PUBLISHED:

Lititz Pharmacopeia

USE: by the military Hospital of the United States Army

1820

• The first US Pharmacopeia through the efforts of Dr. Lyman Spalding, Dr. Samuel Mitchill, and Dr. Jacob Bigelow

1975

USP ACQUIRED NF and Drug standards Laboratory from APhA

1980

• FIRST COMBINED USP-NF was published

2000

USP is revised and published annually, made official every 1ST OF MAY EACH YEAR

1ST OF MAY EACH YEAR

HISTORY OF USP / NF

2000

USP is revised and published annually, made official every ???

USP - 48

NF- 41

2025 LATEST: 

USP -

NF-