Anda di halaman 1dari 7

GENERAL INFORMATION OF B.P AND U.S.

DRUG STANDARDS
As the scientific basis for dr !s and dr ! "rod cts de#e$o"ed% so did the need for nifor& standards to ens re ' a$it(. This need $ed to the de#e$o"&ent and " b$ications of &ono!ra"hs and reference boo)s containin! s ch dr ! standards to be ti$i*ed b( those in#o$#ed in the "rod ction of dr !s and "har&ace tica$ "rod cts. Or!ani*ed sets of &ono!ra"hs or boo)s of these standards are referred to as +"har&aco"oeias, or +for& $aries,. The -ord% "har&aco"oeia% is deri#ed fro& the Gree) Phra&a)on% a dr !% and "oieo% I &a)e. Litera$$(% it is a $ist of &edica$ s bstances% cr de dr !s and for& $ae for &a)in! "re"arations fro& the&. S ch a $ist is co&"$ied b( reco!ni*ed a thorities% s a$$( a""ointed b( the !o#ern&ent of each co ntr(. Most of the "rinci"a$ co ntries of the -or$d ha#e their nationa$ "har&aco"oeias.

THE BIRTH OF PHARMACOPOEIAS


The for& $ation of "har&aco"oeia & st be credited to the in#ention of "rintin! in the fifteenth cent r(% not so & ch beca se "rintin! offered a &eans of " b$ication% b t beca se it had $et to the "rod ction of n &ero s for& $aries and co&"i$ations based on c rrent and ear$ier &an scri"ts -or)s% -ith di#ersed for& $ae and &ethods of "re"aration. The first boo) " b$ished b( the a thorit( of reco!ni*ed " b$ic bod( -as iss ed b( the co$$e!e of F$orence in ./01. It contained the &ost i&"ortant for& $ae for& the -or) of Nicho$as Prae"osit s and additiona$ &atter fro& ancient -riters e.!.% Me se% A#icenna% and Ga$en. The boo) -as iss ed to ens re constanc( in the co&"osition of "re"arations "rescribed b( the F$orentine "h(sicians% &a( therefore be considered as the first officia$ "har&aco"oeia. ---.(o n!"har&acists.co& Pa!e .

The cit( of N re&ber! -as a""arent$( the first co&& nit( to "ossess the "har&aco"oeia -hich -as $e!a$$( bindin! on the a"othecaries 2"har&acists3 of that cit(. In .450 the senate of N re&ber! "assed a $a- -hich re' ired certain "re"arations to be "re"ared to the for& $ae of reci"e boo).

USPNF
The United States Phar&aco"eia6Nationa$ For& $ar( 2USP6NF3 is a boo) of " b$ic "har&aco"eia$ standards. It contains standards for &edicines% dosa!e for&s% dr ! s bstances% e7ci"ients% &edica$ de#ices% and dietar( s ""$e&ents.

USP HISTORY
1820 U.S. Phar&aco"eia fo nded8 a$$ state societies of &edicine in#ited to send de$e!ates8 .. attended. USP created a s(ste& of standards% a s(ste& of ' a$it( contro$ 2for& $ae3% and a nationa$ for& $ar(. On$( 5.9 dr !s that &et the criteria of :&ost f $$( estab$ished and best nderstood: -ere ad&itted. 1830 ;o&&ittee of Re#ision created 2se#en &e&bers38 first re#ision of the USP " b$ished8 re#isions contin e at .<=(ear inter#a$s. S r!eons Genera$ of U.S. Ar&( and Na#( beca&e first federa$ a!encies to "artici"ate in USP re#ision. 1848 Dr ! I&"ort Act6Federa$ $e!is$ation reco!ni*es the USP as an officia$ co&"endi &. 1850 ;o$$e!es of "har&ac( in#ited to "artici"ate in re#ision of the USP. 1880s1890s State Boards of Phar&ac( for&ed8 USP beco&es a state board re' ire&ent. 1900 USP incor"orated in D.;. as not=for="rofit ;or"oration. ;on#ention and Board of Tr stees created. U.S. Phar&aco"eia$

1906 Federa$ Food > Dr !s Act? USP and NF stren!th% ' a$it(% and " rit( reco!ni*ed as officia$ standards. ---.(o n!"har&acists.co& Pa!e 5

1938 Federa$ Food > ;os&etic Act? USP% NF% and @o&eo"athic Phar&aco"eia standards of stren!th% ' a$it(% " rit(% "ac)a!in!% and $abe$in! reco!ni*ed as officia$ and enforced b( FDA. :Ne- Dr !: conce"t estab$ished. FDA a""ro#es dr !s for safet( before &ar)etin!.

1942 USP re#ision c(c$e chan!ed8 USP " b$ished e#er( 4 (ears. 1950 USP estab$ishes its first "er&anent office in Ne- Aor) ;it(. L$o(d ;. Mi$$er% Ph.D.% beco&es first e&"$o(ed director of re#ision. 1963 United States Ado"ted Na&es ;o nci$ for&ed. Re"resentati#es fro& A&erican Medica$ Association 2AMA3% A&erican Phar&acists Association 2APhA3% USP% and FDA estab$ish dr ! no&enc$at re. 1968 USP &o#es its head' arters fro& Ne- Aor) ;it(% e#ent a$$( $ocatin! in Roc)#i$$e% Mar($and% USA. 1970 USP ado"ts reso$ tion ca$$in! for infor&ation to be "ro#ided to dis"ensers of dr !s in United States. Position of e7ec ti#e director created% fi$$ed b( Bi$$ia& M. @e$$er% Ph.D. 1975 USP ac' ires Nationa$ For& $ar( and Dr ! Standards Laborator( fro& APhA. 1977 USP and NF sco"e redefined? USP standards for dr ! s bstances and dosa!e for&s8 NF standards for e7ci"ients. 1980 USP CC and the NF CD " b$ished nder sa&e co#er8 USP Dis"ensin! Infor&ation% .st Edition. 1990 Eero&e A. @a$"erin beco&es USP e7ec ti#e director 2tit$e $ater chan!ed to e7ec ti#e #ice "resident and ;EO3 at the .00< USP ;on#ention. USP &e&bers ado"t a reso$ tion to e7"$ore estab$ishin! standards for #ita&ins and &inera$s.

---.(o n!"har&acists.co&

Pa!e F

1990 1993 Federa$ O&nib s B d!et Reconci$iation Acts 2OBRA G0< and G0F3 na&e the USP Dr ! Infor&ation as a so rce of infor&ation that state Medicaid a!encies co $d se for dr ! ti$i*ation re#ie-% "atient co nse$in!% and &edica$$( acce"ted off=$abe$ ses of &edicines. 1994 USP si!ns an a!ree&ent -ith the A&erican Medica$ Association to co&bine the infor&ation in AMAGs Dr ! E#a$ ations database -ith the USP DI database to de#e$o" a sin!$e "rod ct that contains dr ! and thera"e tic infor&ation.

1995 USP &e&bers ado"t a reso$ tion to e7"$ore estab$ishin! standards for botanica$ dietar( s ""$e&ents. 1997 The &ana!e&ent cons $tin! fir&% McHinse( > ;o&"an(% reco&&ended ne- USP foc s% inc$ din! di#estit re of "rint and e$ectronic dr ! infor&ation "rod cts. 1998 USP se$$s USP DI and associated "rod cts to The Tho&son ;o&"an( and USP DI is " b$ished b( their MI;ROMEDEC s bsidiar(. The ne- Reference Standard ;enter o"ens. MEDMARCI% an Internet=accessib$e &edication errors re"ortin! "ro!ra& for hos"ita$s% is $a nched. 1999 USP " b$ishes fina$ USP DI in three=#o$ &e for&at8 " b$ishes USP 5/6NF .08 initiated &oderni*ation "roJect for de#e$o"in! e=co&&erce ca"abi$ities and estab$ishin! e$ectronic co&& nications -ith constit ents. 2000 At the USP ;on#ention in A"ri$ 5<<<% Ro!er L. Bi$$ia&s% M.D.% beco&es USP e7ec ti#e #ice "resident and ;EO8 &e&bers #ote to chan!e na&e of ;o&&ittee of Re#ision to ;o nci$ of E7"erts and e$ect chair"ersons for K5 E7"ert ;o&&ittees. 2002 USP6NF " b$ished ann a$$(.

MONOGRAPHS AND GENERA! CHAPTERS


The USP6NF is a three #o$ &e co&bination of t-o officia$ co&"endia% the United States Phar&aco"eia 2USP3 and the Nationa$ For& $ar( 2NF3. Mono!ra"hs for dr ! ---.(o n!"har&acists.co& Pa!e /

s bstances and "re"arations are feat red in the USP. Mono!ra"hs for dietar( s ""$e&ents and in!redients a""ear in a se"arate section of the USP. E7ci"ients &ono!ra"hs are in the NF.

A &ono!ra"h inc$ des the na&e of the in!redient or "re"aration8 the definition8 "ac)a!in!% stora!e% and $abe$in! re' ire&ents8 and the s"ecification. The s"ecification consists of a series of tests% "roced res for the tests% and acce"tance criteria. These tests and "roced res re' ire the se of officia$ USP Reference Standards. Medicina$ in!redients and "rod cts -i$$ ha#e the sti" $ated stren!th% ' a$it(% and " rit( if the( confor& to the re' ire&ents of the &ono!ra"h and re$e#ant !enera$ cha"ters.

BRITISH PHARMACOPOEIA
HISTORY
The re! $ation of &edicina$ "rod cts b( officia$s in the United Hin!do& dates bac) to the rei!n of Hin! @enr( DIII 2./0.6.4/93. The Ro(a$ ;o$$e!e of Ph(sicians of London had the "o-er to ins"ect a"othecariesL "rod cts in the London area and to destro( defecti#e stoc). The first $ist of a""ro#ed dr !s -ith infor&ation on hothe( sho $d be "re"ared -as the London Phar&aco"oeia " b$ished in .K.1. The first edition of the British Phar&aco"oeia -as " b$ished in .1K/ and -as one of the first atte&"ts to har&oni*e "har&ace tica$ standards bet-een different co ntries% thro !h the &er!er of the London% Edinb r!h and D b$in Phar&aco"oeias. A ;o&&ission -as first a""ointed b( the Genera$ Medica$ ;o nci$ 2GM;3 -hen the bod( -as &ade stat tori$( res"onsib$e nder the Medica$ Act .141 for "rod cin! a British Phar&aco"oeia on a nationa$ basis. In .0<9 the British Phar&aco"oeia -as s ""$e&ented b( the British Phar&ace tica$ ;ode7% -hich !a#e infor&ation on dr !s and other "har&ace tica$ s bstances not inc$ ded in the BP% and "ro#ided standards for these. The .0K1 Medicines Act estab$ished the $e!a$ stat s of the British Phar&aco"oeia ;o&&ission and of the BP as the UH standard for &edicina$ "rod cts nder section / of the Act. The British Phar&aco"oeia ;o&&ission contin es the -or) of the ear$ier ;o&&issions a""ointed b( the GM; and is res"onsib$e for "re"arin! needitions of the British Phar&aco"oeia and the British Phar&aco"oeia 2Deterinar(3 and for )ee"in! the& " to date. Under Section .<< of the Medicines Act% the British ---.(o n!"har&acists.co& Pa!e 4

Phar&aco"oeia ;o&&ission is a$so res"onsib$e for se$ectin! and de#isin! British A""ro#ed Na&es. Since its first " b$ication bac) in .1K/ the distrib tion of the British Phar&aco"oeia has !ro-n thro !ho t the -or$d. It is no- sed in o#er .<< co ntries. A stra$ia and ;anada are t-o of the co ntries that ha#e ado"ted the BP as their nationa$ standard a$on!side the UH% and in other co ntries 2e.!. Horea3 it is reco!ni*ed as an internationa$$( acce"tab$e standard.

CONTENT
The c rrent edition of the British Phar&aco"oeia co&"rises si7 #o$ &es -hich contain near$( F%<<< &ono!ra"hs for dr ! s bstances% e7ci"ients and for& $ated "re"aration% to!ether -ith s ""ortin! Genera$ Notices% A""endices 2test &ethods% rea!ents etc3 and Reference S"ectra sed in the "ractice of &edicine% a$$ co&"rehensi#e$( inde7ed and cross=referenced for eas( reference. Ite&s sed e7c$ si#e$( in #eterinar( &edicine in the UH are inc$ ded in the BP 2Deterinar(3. Do$ &es I and II Medicina$ S bstances Do$ &e III For& $ated Pre"arations B$ood re$ated Pre"arations%

I&& no$o!ica$ Prod cts% Radio"har&ace tica$ Pre"arations S r!ica$ Materia$s @o&eo"athic Pre"arations

Do$ &e ID A""endices Infrared Reference S"ectra

Inde7

Do$ &e D British Phar&aco"oeia 2Deterinar(3 Do$ &e DI 2;D=ROM #ersion3 ---.(o n!"har&acists.co& Pa!e K

British Phar&aco"oeia British Phar&aco"oeia 2Deterinar(3 British A""ro#ed Na&es

---.(o n!"har&acists.co&

Pa!e 9

Anda mungkin juga menyukai