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
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S. HRG. 110-129 Bioidentica
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CONTENTS Page Opening Statement of
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2 The sale of bioidentical hormone
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4 ever, as Dr. Wartofsky points out
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6 with every stage of the disease:
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8 I am pleased to appear before thi
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10 When the trials began, many rese
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Women who began treatment more than
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14 One small trial using oral estra
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16 FDA is aware that a growing numb
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18 DEPARTMENT OF HEALTH & HUMAN SER
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20 safety and efficacy. However, as
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22 adulteration and misbranding pro
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24 The 2002 CPG reflects FDA's curr
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26 Equally concerning are claims by
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28 concerned about the use and mark
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30 Part I: Materials and Partnershi
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32 drugs, when the compounding of t
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34 Our staff identified 34 Web site
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1. Introduction 36 Chairman Kohl, R
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diet and fitness products. 5 For ex
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include "natural" progesterone crea
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42 unique to the computer age, such
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computer users to spam(ftuce.0ov -
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46 accuracy of advertising for heal
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48 Now, you have identified in your
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50 claim." Therefore, since the ter
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52 Such quality control problems ha
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54 Statement Before the U.S. <stron
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in the U.S., whereas WHI participan
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58 between science and hearsay and
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60 How can we determine whether bio
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62 doctors-are not getting the obje
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64 27. Writing Group for the PEPI T
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66 Dr. MANSON. Well, I think that m
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68 Statement of Leonard Wartofsky,
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70 in the WHI. In fact, no study as
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In summary, the Endocrine Society i
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74 The FDA also regulates aspects o
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Statement of Loyd V. Allen, Jr., Ph
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82 Senator SMITH. Dr. Allen, as I h
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84 Now, when you are talking about
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86 The only thing the WHI proved wa
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88 Testimony Of T.S. Wiley before t
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Confusion and Media Hype 90 Instead
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92 see a doctor tell a diabetic nea
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94 the only compelling reason to ta
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96 identical hormones synthesized f
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98 The world as we know it, from ba
Page 103 and 104: 100 thereby experienced long period
Page 105 and 106: 102 Bio-identical progesterone repl
Page 107 and 108: 104 had reached optimum theoretical
Page 109 and 110: 106 and the patient can be can reas
Page 111 and 112: 108 Estradiol and Analytical Resear
Page 113 and 114: 110 A controlled systematic pilot c
Page 115 and 116: 112 of set doses. The Wiley Protoco
Page 117 and 118: 114 I'd advocate for either Accredi
Page 119 and 120: 116 D.C., and established a goal to
Page 121 and 122: 118 If this legislation passes, fed
Page 123 and 124: first and second finger on the barr
Page 125 and 126: 122 These products that have been s
Page 127 and 128: 124 Bcl-2, survivin and variant CD4
Page 129 and 130: 126 These are experiments by other
Page 131 and 132: 128 cerebro-cellular inflammation c
Page 133 and 134: 130 Years # women *1>0.5 8 *1+ 9 *2
Page 135 and 136: *Breast cancer 132 -57 y.o. recurre
Page 137 and 138: 134 *Labor intense for patient and
Page 139 and 140: 136 Senator SMITH. Thank you very m
Page 141 and 142: 138 makes these hormones uniquely s
Page 143 and 144: 140 tomize the Wiley Protocol by ra
Page 145 and 146: 142 "natural," because all lead to
Page 147 and 148: 144 maceutical commerce, often with
Page 149 and 150: 146 WHITE PAPER #1 DID YOU KNOW THA
Page 151 and 152: 148 WHITE PAPER #2 Pharmacy Compoun
Page 153: 150 bleeding of the bowel, locate t
Page 157 and 158: 154 I. The FDA's definition of a "N
Page 159 and 160: 156 ORIIGINAL CONTrMIBTION JANMA-EX
Page 161 and 162: Initially, the design allowed women
Page 163 and 164: ards analyses," stratified by clini
Page 165 and 166: year). These 'drop-in" rates were a
Page 167 and 168: years of prior use, 11 vs 2; HR, 4.
Page 169 and 170: trogen plus progestin exposure. Clo
Page 171 and 172: 168 RISKS AND BENEFITS OF ESTROGEN
Page 173 and 174: EFFECTS OF POSTMENOPAUSAL ESTIROGEN
Page 175 and 176: EFFECTS OF POSTMENOPAUSAL ESTROGEN
Page 179 and 180: pEyECTS OF POSTMENOPAUSAL ESTROGEN
Page 185 and 186: 10000 isoor i I ea '° a wan 20-24
Page 187 and 188: ~SDt~rpa g~2~Q ~ !~fm~. b~e ~ ng jh
Page 189 and 190: Is associated with an Increased ris
Page 191 and 192: 188 Postmenopausal hormone therapy
Page 193 and 194: group (P= 04001), and In this subgr
Page 195 and 196: Treatmnent recommendations Based on
Page 197 and 198: 21.Grodsteln F. Manson JE, Colditz
Page 199 and 200: _ ORWIGNAL CONTIuBUTION 196 Postmen
Page 201 and 202: showed no striking differences in H
Page 203 and 204: (214 cases; P for trend=.72): howev
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202 HORMONE THERAPY USE AND RISK OF
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mal studies, and laboratory studies
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210 ,lmcCII na: CLI I tr: tarty ver
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212 ,mucmai rimi &ronos farty bstro
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214 LntIucwu miau: rronos nary estr
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XVI. PNharmacy Licensure Requiremen
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XVI. Pharmacy Licensure Requirement
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220 Roster of Board of Pharmacy Ece
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050. 0l7404405400 Al-h. PeVbU 03283
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Conclusions * Age is a powerful ris
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Women's Health Initiative Trials of
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Hormone Therapy after WHI * Change
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Statement of the American Pharmacis
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232 APhA Statement to the S
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240 Written Testimony of Steven F.
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242 STATEMENT OF DAVID G. ADAMS On
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244 Report on State Laws and Regula
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246 Only one state, Utah, requires
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248 5. Compounding Copies of FDA-Ap
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Bioidentical Hormones - U.S. Senate Special Committee on Aging

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