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

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XVI. Pharmacy Licensure Requirements (cain 217 Is I heth a Separtct Inittil Controlled Controlled Licensing Controlled Subslance Substance Citegots Flor Subsonse Renewal R--ilea Onliine Itere Stoi Fec 1en Schedule pharmactes'? Colorado None None _ No Connectcut None None - No Delaware S40 S40 2 years No Distoret of Coloombia $50 $50 I erNo A,~~sss'no~s 4e&~' ~'~is oO2 Ataas No Kansas None lrsA~'~ Non --- Indiana No~' VW0 S100 2 yeltn; No X iowa S100- S100' 2years No Z Illinois $~~~~~S5 S55 2 years No Minnesota IowaMxr None SloO None StiOC * -IZye No NoZ Missisnippi zr~~k'.'\ ,,t~~~i$25sKC S50 $50 2 years I No MNssour >~S0 None I ynrcc 'Now None - No North Carulna None None ' No North Dakota None None .- No M Island SouthCamobn S50 S125 $50 S125 Noyenr I yeao No No South Dakota TenMesrsp M ,M S40 S40 3 years M 2 years No No Wesl Vngmra S25 ~~~ ~ ~~~S25 I year No Wisconsm None None D No Wy'mAng S'4e S40 I y ar No Sc eFootnotes ""on pges 49.50.
XVI. Pharmacy Licensure Requirements (Cot-) LEGEND A B C D - - - If phrauay ships, sails, delives. dispenses, auror provides prescription drugs andior devices to state residents. (TX - If piharmiacy rouincly provides such srvices. WV- If snore than 10Y. of prescriplion volume is dispensed by mal.) Registered, nt licensed. $150 for nnneesidonm phanmacies. Prorated inital licensing fee; enesnl fee van cs. E - One licensed AR phanracisi required F as phanmacist-mn-chage (PIC) for AR perreil. If ocling as PIC of a licensed mur-of-slate phanmacy. G ii I J - Odd years, (1l - S295.) State Depaotinenl of Public Safety, Narcoucs Esforvemesn Division. - Even yeas (Hl -5185.) - Mail Order Annual Fee -$250: Mail Order Initial Fee -S500 K L M N O P - UnlCss they enter state to previdC phaoeacy services. - One licensed LA pharmacist requinrd as PIC for LA pennit. - Nol handled by tho Board of Phannacy. - S200, communitry pharmacy and inslituaonal full-timc phunarcy - S160, instaidional part-sime pharmacy. - Issuod by Tcsas Department of Public Safety. Q R NE-liccnsod pharmacist must bh employed by the pharmacy. Not addressed in pharmacy act or Board regualaions. S - ReCaired by the leca Controlled Substances Acl. Fontnotes (-) AK - Rerail, instihutional. drug mom, out-ofstaic. AR - Hospital, instiluiional, retail, charitable clinic. AZ- Community, hospital, limited strvicc CA - Comruanity pharmacy, hospital pharmacy, eae-pi hospital, oat-of-state, licensed carrectional facility, siteile compoaasding facility. CT - Community, naclear. long-term care, inhasion specialty DC - Retail, instsirtional, nuclear, special, or limited use. FL - Class I instimutional (sursing home). Class It instiluional (hospital), Modified Class IIA, Modified Class IIB, Mdified Class IIC, comnuoniry, special purenterati ent-rat. special no-rsidest, special ctostd .ystem, special end stage renal GA - discaas, annual shelter, nuclear. <strong>Special</strong> parcntcrulrcnteral extended scope. Specitl assisted trying focitity- InteinetL noaesideel. Retail, hospital, eucrur, prison, pharmacy schol, pharmacy clinic, pharmacy -encfito manager, rCseareher, opioid ureaumenl center. 218 T - $220 - dd years: S270 - even years for pharmacy renosal. U - Not by this state, but by the state in which the phalrucy is located. V - They ore considered to be "limited scricc." W All out-of-sta pharmacies in same crtegory. X - Rogisiers those entities as nonresident pharmacists. Y - They would be cumsiderod mail ervice if we licensed them. Z - Pharmacies would be licensed in the same manner as a 'bick-and-mortar" pharmacy based on location. AA - Plus Controlled Substance fee of S I 5 1. BB - No separate category. A fitl service phaosacy in MD may have an online/ Intotni component or a pharmacy may rercio a waiver to perform only this scrvice. Nonresident pharntacist (out-of-statl) mast comply with genertl noersident regilatons. CC Licoasure of nntresident pharmacists is required when performing remote entry acuvhiies, but does not dispense prescnptions into the state (telemedicinc). DD- Controlled sahbsuin-s registration is hardled by another state agency, nor the Board of Pharuacy. EE - Plus one-tim application fee of 550. FF - 5600 foe out-of-sutte pharmcies. GG - If pharmacy is shipping 25 or more prscriptions per month into KY, must havc KY phaenacy pernit and a KY licensed pharmacist as a phamacist-incharge. Hi - Pharmacy license and miswettnenas permit for out-of-state pharmacims. IA - G(eneml, hospital, limited use, nonrCsident Controllcd substance cegistration not required for wnresidenl pharmances. ID - Retil drug outlet, instuitional drug outlet, parentenml, an-phartnocy drug onaler, limited teroie, out-of-sutt mait sewvice phartmacy IL - Retail; eff-site hospital, nursing home pharnacies an-site hospital. nursing hnmr pharmacies: Nuctr, arubulaury cam facility pharmacies and hospital mr nursiug home phanmacies providing services the general public. IN Based on type of business conducted. KS - Rsident and resident. LA Commtnity. hospital, insitiutional, eucICar, oharitabc, out-of-sta. MA - Retail and nuclear restricted. MD Full service pharmacy permit; vatinus waivc pcermits. Nonresident pharmacy permit. ME -- Retail, rural health centcr, mail order Footnotes coumnuc on page 50. 2((07 National Association of Boards of Phatnnacy Survey,/- Pharmacy Law Licensinglaw
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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
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100 thereby experienced long period
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102 Bio-identical progesterone repl
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104 had reached optimum theoretical
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106 and the patient can be can reas
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108 Estradiol and Analytical Resear
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110 A controlled systematic pilot c
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112 of set doses. The Wiley Protoco
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114 I'd advocate for either Accredi
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116 D.C., and established a goal to
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118 If this legislation passes, fed
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first and second finger on the barr
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122 These products that have been s
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124 Bcl-2, survivin and variant CD4
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126 These are experiments by other
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128 cerebro-cellular inflammation c
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130 Years # women *1>0.5 8 *1+ 9 *2
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*Breast cancer 132 -57 y.o. recurre
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134 *Labor intense for patient and
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136 Senator SMITH. Thank you very m
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138 makes these hormones uniquely s
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140 tomize the Wiley Protocol by ra
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142 "natural," because all lead to
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144 maceutical commerce, often with
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146 WHITE PAPER #1 DID YOU KNOW THA
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148 WHITE PAPER #2 Pharmacy Compoun
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150 bleeding of the bowel, locate t
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152 compounding standards can be en
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154 I. The FDA's definition of a "N
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156 ORIIGINAL CONTrMIBTION JANMA-EX
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Initially, the design allowed women
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ards analyses," stratified by clini
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year). These 'drop-in" rates were a
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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
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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
Page 205 and 206: 202 HORMONE THERAPY USE AND RISK OF
Page 207 and 208: mal studies, and laboratory studies
Page 213 and 214: 210 ,lmcCII na: CLI I tr: tarty ver
Page 215 and 216: 212 ,mucmai rimi &ronos farty bstro
Page 217 and 218: 214 LntIucwu miau: rronos nary estr
Page 219: XVI. PNharmacy Licensure Requiremen
Page 223 and 224: 220 Roster of Board of Pharmacy Ece
Page 225 and 226: 050. 0l7404405400 Al-h. PeVbU 03283
Page 227 and 228: Conclusions * Age is a powerful ris
Page 229 and 230: Women's Health Initiative Trials of
Page 231 and 232: Hormone Therapy after WHI * Change
Page 233 and 234: Statement of the American Pharmacis
Page 235 and 236: 232 APhA Statement to the S
Page 243 and 244: 240 Written Testimony of Steven F.
Page 245 and 246: 242 STATEMENT OF DAVID G. ADAMS On
Page 247 and 248: 244 Report on State Laws and Regula
Page 249 and 250: 246 Only one state, Utah, requires
Page 251: 248 5. Compounding Copies of FDA-Ap
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Bioidentical Hormones - U.S. Senate Special Committee on Aging

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