Bioidentical Hormones - U.S. Senate Special Committee on Aging

Bioidentical Hormones - U.S. Senate Special Committee on Aging Bioidentical Hormones - U.S. Senate Special Committee on Aging

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151 WHITE PAPER #3 RECENT ADVANCES IN QUALITY PHARMACY COMPOUNDING In the past, Compounding Was Pharmacy! Throughout history, pharmacists have compounded drugs for individualized dosages for patients when they were prescribed by physicians. In the early 1900s however, the pharmaceutical industry began manufacturing a myriad of drugs and dosage forms for patients and the need for compounding diminished. Since the late 1900s however, a lot has changed and the pharmaceutical industry no longer supplies all the medications needed by patients. Pharmacy compounding has experienced tremendous growth. It has not, however, been without its detractors. True, there have been some difficulties along the way, but recently great strides have been made to enhance the quality of pharmacy compounding, including the following: PHARMACY COMPOUNDING ACCREDITATION BOARD A consortium of eight national pharmacy organizations have worked together to estallish the Pharmacy Compounding Accreditation Board. Operating through the offices of the National Association of Boards of Pharmacy, this board began the process of accrediting compounding pharmacies in the spring of 2005. The accreditation standards are rigid and require comprehensive documentation of a quality operation. Although voluntary, there are potentially some distinct advantages to becoming an accredited compounding pharmacy. US. PRARMAMcPFYA-At T AIf?.iA Fnred ,f tF A DV Beginning in 1985 at the U.S. Pharmacopoeial Convention, a resolution regarding pharmacy compounding was passed, and this has been followed by resolutions at the 1990, 1995, 2000, and the 2005 conventions concerning increased efforts in establishing pharmacy compounding standards and especially efforts related to special populations (pediatrics). In recent years, two enforceable general chapters have been implemented, including USP Chapter Pharmaceutical Compounding--Nonsterile Preparations, and USP Chapter Pharmaceutical Compounding-Sterile Preparations. In addition, two additional USP informational chapters are in effect, including, USP Chapter Good Compounding Practices, and USP Chapter Pharmaceutical Calculations in Prescription Compounding. A new chapter on Quality Control in Pharmacy Compounding has been prepared. In addition to the General Chapters, the USP-NF currently contains approximately 225 monographs related to pharmacy compounded preparations. U.S. PHARMACOPEIA-PHARMACISTS PHARMACOPEIA The U.S. Pharmacopeia was originally developed for pharmacists. However, the emphasis of the current USP-NF is directed towards the pharmaceutical industry. The USP-Pharmacists Pharmnacopeia was launched in the summer of 2005. This set of

152 compounding standards can be enforced by the State Boards of Pharmacy, as well as the US Food and Drug Administration. The USP-Pharmacisr5 Pharmacopeia is divided into srEMIcTEs AGr = 1 two sections. Section one contains monographs for compounding substances and -de e->ny 4id -°M excipients and monograph standards for compounded preparations, as well as general .tap orsna n a= aaa~aaa chapters related to compounding standards. Section two contains supportive information ..aaa mfi- thabaI for quality pharmacy compounding. This compendium will be continually revised and DOSAGE FORMS TIC updated. 1. LiM M ii OGETW FORMIS AMERICAN COUNCIL ON PHARMACEUTICAL EDUCATION (ACPE) anij-a ikiara, aTbnia ,nda The American Council on Pharmaceutical Education has requested performance . t -M WCyrg= q es outcomes related to pharmacy compounding. These will be presented to ACPE this . m. r a ,tiain spring for consideration for implementation in the curriculum of accredited Colleges of Pharmacy throughout the U.S. ACPE standards are required for accreditation of Colleges d:4w atrae,-r_ of Pharmacy. barin,, a - ft,,a s-9al f AMERICAN ASSOCIATION OF COLLEGES OF PHARMACY (AACP) , -TEACHERS OF PHARMACEUTICS * , nonarEtrLTTaICARE!. The Teachers of Pharmaceutics section of AACP is surveying its membership to . rta-nran - i. i-4uiddt b determine the current status of pharmaccutics and compounding in the curriculum. The ! _ ( r in-depth survey is designed to identify course content that is either taught as separate., a,, ' , n ia roa free-standing courses, or as an integrated component of other courses. , ,rt PHARMACY COMPOUNDING EDUCATIONAL PROGRAMS I I Many pharmacy compounding support companies, as well as the InternationalJournal of Phartnnceuiical Compounding, provide programs and information on pharmacy compounding. In addition, there are several books and websites available (e.g., www.ijmc.com; www.compoundinatodavycom) that provide information to support pharmacists in all practice sites (community, hospital. home healthcare, etc.) in pharmacy ti aa_ da i adaraw . t ir a n-,ded w, 5alaa aahr . o : . 4. stosPICE .dPALLIATIVE compounding, : ':' nPATEt oEaafaaay. S: . = diff M -eWi,. d.. f LABORATORY SUPPORT .la 0aanaaa an ,00 t Analytical support is provided by several laboratories throughout the U.S., many of Flatlned00un which are FDA-registered and -inspected. Potency analysis, sterility and endotoxin I Itesting is now commonplace. In addition to oubsourcing to these laboratories, some pharmacies (community as well as hospital) use in-house testing when appropriate. I i t D e a I ,r- odwahsadnuaak ,,,, air, antrana m acramaah -t day oyd V. Alleti, fr., Ph.D., Editor-in-Chief, Interoational Journal of Pharmaceutical... ...... nek mW-npo taa Compounduin ----w IJPCraam - ,,, d rn mari-a, l . P .an~. rtnarnt 12D 01

152<br />

compounding standards can be enforced by the State Boards of Pharmacy, as well as the<br />

US Food and Drug Administrati<strong>on</strong>. The USP-Pharmacisr5 Pharmacopeia is divided into srEMIcTEs AGr = 1<br />

two secti<strong>on</strong>s. Secti<strong>on</strong> <strong>on</strong>e c<strong>on</strong>tains m<strong>on</strong>ographs for compounding substances and -de e->ny 4id -°M<br />

excipients and m<strong>on</strong>ograph standards for compounded preparati<strong>on</strong>s, as well as general .tap orsna n a= aaa~aaa<br />

chapters related to compounding standards. Secti<strong>on</strong> two c<strong>on</strong>tains supportive informati<strong>on</strong> ..aaa mfi- thabaI<br />

for quality pharmacy compounding. This compendium will be c<strong>on</strong>tinually revised and DOSAGE FORMS TIC<br />

updated.<br />

1. LiM M ii OGETW FORMIS<br />

AMERICAN COUNCIL ON PHARMACEUTICAL EDUCATION (ACPE)<br />

anij-a ikiara, aTbnia ,nda<br />

The American Council <strong>on</strong> Pharmaceutical Educati<strong>on</strong> has requested performance . t -M WCyrg= q es<br />

outcomes related to pharmacy compounding. These will be presented to ACPE this . m. r a ,tiain<br />

spring for c<strong>on</strong>siderati<strong>on</strong> for implementati<strong>on</strong> in the curriculum of accredited Colleges of<br />

Pharmacy throughout the U.S. ACPE standards are required for accreditati<strong>on</strong> of Colleges<br />

d:4w atrae,-r_<br />

of Pharmacy. barin,, a - ft,,a s-9al f<br />

AMERICAN ASSOCIATION OF COLLEGES OF PHARMACY (AACP) ,<br />

-TEACHERS OF PHARMACEUTICS<br />

* , n<strong>on</strong>arEtrLTTaICARE!.<br />

The Teachers of Pharmaceutics secti<strong>on</strong> of AACP is surveying its membership to . rta-nran - i. i-4uiddt b<br />

determine the current status of pharmaccutics and compounding in the curriculum. The ! _ ( r<br />

in-depth survey is designed to identify course c<strong>on</strong>tent that is either taught as separate., a,, ' , n ia roa<br />

free-standing courses, or as an integrated comp<strong>on</strong>ent of other courses. , ,rt<br />

PHARMACY COMPOUNDING EDUCATIONAL PROGRAMS<br />

I<br />

I Many pharmacy compounding support companies, as well as the Internati<strong>on</strong>alJournal of<br />

Phartnnceuiical Compounding, provide programs and informati<strong>on</strong> <strong>on</strong> pharmacy<br />

compounding. In additi<strong>on</strong>, there are several books and websites available (e.g.,<br />

www.ijmc.com; www.compoundinatodavycom) that provide informati<strong>on</strong> to support<br />

pharmacists in all practice sites (community, hospital. home healthcare, etc.) in pharmacy<br />

ti aa_ da i<br />

adaraw .<br />

t ir a n-,ded w, 5alaa aahr<br />

. o :<br />

. 4. stosPICE .dPALLIATIVE<br />

compounding, : ':' nPATEt oEaafaaay.<br />

S:<br />

. = diff M -eWi,. d.. f<br />

LABORATORY SUPPORT .la 0aanaaa an ,00 t<br />

Analytical support is provided by several laboratories throughout the U.S., many of Flatlned00un<br />

which are FDA-registered and -inspected. Potency analysis, sterility and endotoxin<br />

I<br />

Itesting is now comm<strong>on</strong>place. In additi<strong>on</strong> to oubsourcing to these laboratories, some<br />

pharmacies (community as well as hospital) use in-house testing when appropriate.<br />

I<br />

i<br />

t D e a<br />

I ,r- odwahsadnuaak<br />

,,,, air, antrana<br />

m acramaah -t day<br />

oyd V. Alleti, fr., Ph.D., Editor-in-Chief, Interoati<strong>on</strong>al Journal of Pharmaceutical... ...... nek mW-npo taa<br />

Compounduin ----w IJPCraam -<br />

,,, d rn mari-a, l<br />

. P<br />

.an~. rtnarnt 12D 01

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