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

More documents

Recommendations

Info

247 * Six states have no standards related to the compounding of sterile pharmaceutical products. * Eight states have standards thatfail to address compounding of sterile inhalation solutions. Inhalation solutions must be sterile and are currently manufactured by compoundinfg pharmacies on a massive scale. Eight states have addressed sterile compounding of injectable products without addressing inhalation solutions. See Ala. Admin. Code r. 680-x-2.19 (2007); Cal. Code Regs. tit. 16, § 1751.02, et seq. (2007); D.C. Mun. Regs. Tit. 22, § 1923 (2007); Idaho Admin. Code r. 27.01.01.178 (2007); III. Admin. Code tit. 68, § 1330.99 (2007); Kan. Admin. Regs. § 68-13-1 (2007); 201 Ky. Admin. Regs. 2:076 (2007); N.D. Admin. Code 61-06-01-01, et seq. (2007). * Most states have no requirements specific to high-risk compounding. Many inhalation drugs, as well as other drugs that must be sterile, are being compounded from nonsterile ingredients. The USP defines such compounding as "high-risk" compounding. Because such compounding is very difficult and poses special risks for patients, the USP provides stricter standards for high-risk compounding in USP . Most states that provide standards for sterile compounding fail to address the special concerns posed by high-risk compounding. See Ariz. Admin. Code § 4-23-670 (2007); Alaska Division of Corporations, Business and Professional Licensing, Alaska Pharmacy Statutes and Regulations (2007), at Appendix A and Appendix C; Iowa Admin Code r. 657-8.30 (2007); La. Admin. Code tit. 46, §§ 2535(2), 2537; 02-392-018 Me. Code R. § flet tn7 AA - xAA r',.4- 0,. -_ n 'I I 1901 Al. flff'00 1, et seq. {200?); Md. C ode V ;M. 10... 6ouU.aUUU - 6800.8008 U2007); Mont. Admin. R. 24.174.1121 (2007); Nev. Admin. Code §§ 639.525(5), 639.684 (2007); N.H. Code R. Ph. 404.01, et seq. (2007); N.J. Admin. Code § 13:39-11.1, et seq. (2007); N.C. Admin. Code 46.2800, et seq. (2007); Okla. Admin. Code § 535:15-19-1, etseq. (2007); Or. Admin. R. 855-041-0063 (2007); 14-130-001 R.I. Code R. § 19 (2007); S.C. Code Ann. § 40-43-88 (2007); S.D. Admin. R. 20:51:26:01, et seq. (2007); Tenn. Comp. R. & Regs. 11 40-7-.0 1, et seq.; 04-030-230 Vt. Code R. part G (2007); Wash. Admin. Code §§ 246-878-040(1), 246-878-050; W. Va. Code R. §§ 15-1-15.2.3, 15-1-16 (2007); Wis. Admin. Code Pharm. Examin. Bd., § 15.01, etseq. (2007); 024-059-013 Wyo. Code R. § 10 (2007). Only eight states with sterile compounding standards address high-risk compounding. See 070-02-0001 Ark. Code R. (2007); Ga. Comp. R. & Regs. 480-11- 0.02, Ga. Comp. R. & Regs. 480-11-.04 (2007); 3 Colo. Code Regs. § 719-1 (2007); 10- 522-001 Del. Code Regs. § X (2007); Fla. Admin. Code Ann. r. 64B16-28.820 (2007); Mo. Code Regs. Ann. tit. 20, §§ 2220-2.200, 2220-2.020 (H) (2007); Ohio Admin. Code 4729:19-04,4729:9-25 (2007); 22 Tex. Admin. Code § 291.26 (2007); 18 Va. Admin. Code § 110-20-411, et seq. (2007).
248 5. Compounding Copies of FDA-Approved Drugs The vast majority of states impose no restriction on the compounding of copies of FDA-approved drugs. Only eight states impose limitations on substitution compounding. See Iowa Admin. Code r. 657-20.3(1) (requiring a "significant difference" from the FDA-approved product, which would include, for example, the removal of a dye for a medical reason such as an allergic reaction); La. Admin. Code tit. 46, § 2533 (2007) (excluding from the definition of compounding "the compounding of drug products that are essentially copies of a commercially available product"); N.M. Code R. § 16.19.30.9 (2007) (requiring that the commercial product not be reasonably available from normal distribution channels in a timely manner to meet patient's needs and that the prescribing practitioner request that the drug be compounded); 14-130-001 R.I. code R. § 1.19 (2007) (excluding from the definition of compounding "the routine preparation, mixing or assembling of drug products that are essentially copies of a commercially available product"); Utah Code Ann. § 58-17b-102(18)(b) (2007) (excluding from the definition of compounding "the preparation by a pharmacist or pharmacist intern of any prescription drug in a dosage form which is regularly and commonly available from a manufacturer in quantities and strengths prescribed by a practitioner"); 024-059-013 Wyo, Code R. § 3(a) (limiting to medications or dosage forms that are not commercially available in the marketplace); 07- 02-0001 Ark. Code R. § I (requiring documentation provided by the prescriber of a patient specific medical need or the unavailability of the drug product in the marketplace); Wash. Admin. Code § 246-878-020(1) (requiring both the patient and the prescriber authorize in writing the use of the compounded product); Alaska Division of Corporations, Business and Professional Licensing, Pharmacy Laws and Regulations, at Appendix C (requiring the authorization of the prescribing practitioner). Two states expresslypermit such substitution compounding. In Georgia and South Carolina, such compounding is specifically permitted when (I) based on the existence of a pharmacist/patient/prescriber relationship and the presentation of a valid prescription drug order; or (2) in anticipation of a prescription drug order based on routine, regularly observed prescribing patterns. See Ga. Comp. R. & Regs. 480- 1l - 0.02 (2007); S.C. Code Ann. § 40-43-86 (2007). CONCLUSION Congress determined over 60 years ago when it enacted the FDCA that patients receiving compounded drugs, like patients receiving commercially available drugs, are entitled to protection under federal law as well as under state law. While opponents of FDA oversight of pharmacy compounding argue that state regulation is adequate and obviates the need for federal standards, it is clear that state laws and regulations fail to provide many of the basic protections offered to patients under the current provisions of the FDCA and under proposed revisions to the statute. Dated: May 15, 2007 0
Page 1 and 2:
S. HRG. 110-129 Bioidentica
Page 3 and 4:
CONTENTS Page Opening Statement of
Page 5 and 6:
2 The sale of bioidentical hormone
Page 7 and 8:
4 ever, as Dr. Wartofsky points out
Page 9 and 10:
6 with every stage of the disease:
Page 11 and 12:
8 I am pleased to appear before thi
Page 13 and 14:
10 When the trials began, many rese
Page 15 and 16:
Women who began treatment more than
Page 17 and 18:
14 One small trial using oral estra
Page 19 and 20:
16 FDA is aware that a growing numb
Page 21 and 22:
18 DEPARTMENT OF HEALTH & HUMAN SER
Page 23 and 24:
20 safety and efficacy. However, as
Page 25 and 26:
22 adulteration and misbranding pro
Page 27 and 28:
24 The 2002 CPG reflects FDA's curr
Page 29 and 30:
26 Equally concerning are claims by
Page 31 and 32:
28 concerned about the use and mark
Page 33 and 34:
30 Part I: Materials and Partnershi
Page 35 and 36:
32 drugs, when the compounding of t
Page 37 and 38:
34 Our staff identified 34 Web site
Page 39 and 40:
1. Introduction 36 Chairman Kohl, R
Page 41 and 42:
diet and fitness products. 5 For ex
Page 43 and 44:
include "natural" progesterone crea
Page 45 and 46:
42 unique to the computer age, such
Page 47 and 48:
computer users to spam(ftuce.0ov -
Page 49 and 50:
46 accuracy of advertising for heal
Page 51 and 52:
48 Now, you have identified in your
Page 53 and 54:
50 claim." Therefore, since the ter
Page 55 and 56:
52 Such quality control problems ha
Page 57 and 58:
54 Statement Before the U.S. <stron
Page 59 and 60:
in the U.S., whereas WHI participan
Page 61 and 62:
58 between science and hearsay and
Page 63 and 64:
60 How can we determine whether bio
Page 65 and 66:
62 doctors-are not getting the obje
Page 67 and 68:
64 27. Writing Group for the PEPI T
Page 69 and 70:
66 Dr. MANSON. Well, I think that m
Page 71 and 72:
68 Statement of Leonard Wartofsky,
Page 73 and 74:
70 in the WHI. In fact, no study as
Page 75 and 76:
In summary, the Endocrine Society i
Page 77 and 78:
74 The FDA also regulates aspects o
Page 79 and 80:
Statement of Loyd V. Allen, Jr., Ph
Page 81 and 82:
Page 83 and 84:
Page 85 and 86:
82 Senator SMITH. Dr. Allen, as I h
Page 87 and 88:
84 Now, when you are talking about
Page 89 and 90:
86 The only thing the WHI proved wa
Page 91 and 92:
88 Testimony Of T.S. Wiley before t
Page 93 and 94:
Confusion and Media Hype 90 Instead
Page 95 and 96:
92 see a doctor tell a diabetic nea
Page 97 and 98:
94 the only compelling reason to ta
Page 99 and 100:
96 identical hormones synthesized f
Page 101 and 102:
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 and 154:
150 bleeding of the bowel, locate t
Page 155 and 156:
152 compounding standards can be en
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 177 and 178:
Page 179 and 180:
pEyECTS OF POSTMENOPAUSAL ESTROGEN
Page 181 and 182:
Page 183 and 184:
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
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 and 220: XVI. PNharmacy Licensure Requiremen
Page 221 and 222: XVI. Pharmacy Licensure Requirement
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: 246 Only one state, Utah, requires
show all

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

You also want an ePaper? Increase the reach of your titles

Delete template?

Save as template?