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The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use (2020)

Chapter: Appendix F: Compounded Bioidentical Hormone Therapy Formulations with a Single Active Ingredient

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Page 265 Cite
Suggested Citation:"Appendix F: Compounded Bioidentical Hormone Therapy Formulations with a Single Active Ingredient." National Academies of Sciences, Engineering, and Medicine. 2020. The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25791.
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Appendix F

Compounded Bioidentical Hormone Therapy Formulations with a Single Active Ingredient

Page 266 Cite
Suggested Citation:"Appendix F: Compounded Bioidentical Hormone Therapy Formulations with a Single Active Ingredient." National Academies of Sciences, Engineering, and Medicine. 2020. The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25791.
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No. Active Ingredient Present from Listinga Dosage Form All Reported Active Ingredients All Reported Active Ingredient Strengthsb
1 Dehydroepiandrosterone Capsule Dehydroepiandrosterone 10 mg
2 Dehydroepiandrosterone Capsule Dehydroepiandrosterone 50 mg
3 Dehydroepiandrosterone Cream Dehydroepiandrosterone 0.02
4 Dehydroepiandrosterone Cream Dehydroepiandrosterone 10 mg
5 Dehydroepiandrosterone Cream Dehydroepiandrosterone 10 mg/mL
6 Dehydroepiandrosterone Cream Dehydroepiandrosterone 5 mg/0.1mL
7 Dehydroepiandrosterone Gel Dehydroepiandrosterone 25 mg/mL
8 Dehydroepiandrosterone Solution Dehydroepiandrosterone 25 mg/0.25 mL
9 Dehydroepiandrosterone Suppository Dehydroepiandrosterone 13 mg
10 Estradiol Capsule Estradiol 0.3 mg
11 Estradiol Capsule Estradiol 0.5 mg
12 Estradiol Capsule Estradiol 1 mg
13 Estradiol Capsule Estradiol 2 mg
14 Estradiol Cream Estradiol 0.01 mg/1 mL
15 Estradiol Cream Estradiol 0.1 mg/1 g
16 Estradiol Cream Estradiol 0.1 mg/1 mL
17 Estradiol Cream Estradiol 0.1 mg/1 mL
18 Estradiol Cream Estradiol 0.128 mg/1 mL
19 Estradiol Cream Estradiol; Lidocaine Hydrochloride 0.2 mg/1 g; 50 mg/1 g
20 Estradiol Cream Estradiol 0.2 mg/1 mL
21 Estradiol Cream Estradiol; Lidocaine Hydrochloride 0.5 mg/1 g; 50 mg/1 g
22 Estradiol Cream Estradiol 0.5 mg/1 mL
Page 267 Cite
Suggested Citation:"Appendix F: Compounded Bioidentical Hormone Therapy Formulations with a Single Active Ingredient." National Academies of Sciences, Engineering, and Medicine. 2020. The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25791.
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23 Estradiol Cream Estradiol 0.6 mg/1 mL
24 Estradiol Cream Estradiol 0.625 mg/1 g
25 Estradiol Cream Estradiol 0.625 mg/1 mL
26 Estradiol Cream Estradiol 0.75 mg/1 mL
27 Estradiol Cream Estradiol 0.2%
28 Estradiol Cream Estradiol 1 mg/0.1 g
29 Estradiol Cream Estradiol 1 mg/1 g
30 Estradiol Cream Estradiol 1 mg/1 mL
31 Estradiol Cream Estradiol 1 mg/1 mL
32 Estradiol Cream Estradiol 1.25 mg/1 mL
33 Estradiol Cream Estradiol 1.75 mg/1 mL
34 Estradiol Cream Estradiol 2 mg/1 mL
35 Estradiol Cream Estradiol 2.5 mg/1 mL
36 Estradiol Cream Estradiol 3.6 mg/1 mL
37 Estradiol Gel Estradiol —
38 Estradiol Gel Estradiol 0.2%
39 Estradiol Gel Estradiol 0.5 mg/mL
40 Estradiol Gel Estradiol 1 mg/0.1 mL
41 Estradiol Gel Estradiol 1 mg/1 mL
42 Estradiol Gel Estradiol 2 mg/mL
43 Estradiol Injection Estradiol 5 mg/mL
44 Estradiol Lozenge Estradiol 0.5 mg
45 Estradiol Lozenge Estradiol 1 mg
Page 268 Cite
Suggested Citation:"Appendix F: Compounded Bioidentical Hormone Therapy Formulations with a Single Active Ingredient." National Academies of Sciences, Engineering, and Medicine. 2020. The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25791.
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No. Active Ingredient Present from Listinga Dosage Form All Reported Active Ingredients All Reported Active Ingredient Strengthsb
46 Estradiol Ointment Estradiol 0.1 mg/1 g
47 Estradiol Ointment Estradiol 0.1 mg/1 g
48 Estradiol Ointment Estradiol 0.25 mg/1 g
49 Estradiol Ointment Estradiol 0.5 mg/1 g
50 Estradiol Ointment Estradiol 0.5 mg/1 g
51 Estradiol Ointment Estradiol; Lidocaine Hydrochloride 0.5 mg/1 g; 50 mg/1 g
52 Estradiol Ointment Estradiol; Lidocaine Hydrochloride 0.5 mg/1 g; 50 mg/1 g
53 Estradiol Ointment Betamethasone Dipropionate; Diazepam; Estradiol 1 mg/1 g; 5 mg/1 g; 0.5 mg/1 g
54 Estradiol Pellet Estradiol 10 mg
55 Estradiol Pellet Estradiol 10 mg
56 Estradiol Pellet Estradiol 10 mg
57 Estradiol Pellet Estradiol 10 mg/1 mg
58 Estradiol Pellet Estradiol 10 mg/1 mg
59 Estradiol Pellet Estradiol 10 mg/10 mg
60 Estradiol Pellet Estradiol 12.5 mg
61 Estradiol Pellet Estradiol 12.5 mg
62 Estradiol Pellet Estradiol 12.5 mg
63 Estradiol Pellet Estradiol 12.5 mg
64 Estradiol Pellet Estradiol 12.5 mg/1 mg
65 Estradiol Pellet Estradiol 12.5 mg/1 mg
66 Estradiol Pellet Estradiol 12.5 mg/12.5 mg
Page 269 Cite
Suggested Citation:"Appendix F: Compounded Bioidentical Hormone Therapy Formulations with a Single Active Ingredient." National Academies of Sciences, Engineering, and Medicine. 2020. The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25791.
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67 Estradiol Pellet Estradiol 15 mg
68 Estradiol Pellet Estradiol 15 mg
69 Estradiol Pellet Estradiol 15 mg
70 Estradiol Pellet Estradiol 15 mg/1 mg
71 Estradiol Pellet Estradiol 15 mg/1 mg
72 Estradiol Pellet Estradiol 15 mg/15 mg
73 Estradiol Pellet Estradiol 18 mg
74 Estradiol Pellet Estradiol 18 mg
75 Estradiol Pellet Estradiol 18 mg
76 Estradiol Pellet Estradiol 18 mg/1 mg
77 Estradiol Pellet Estradiol 18 mg/1 mg
78 Estradiol Pellet Estradiol 18 mg/18 mg
79 Estradiol Pellet Estradiol 20 mg
80 Estradiol Pellet Estradiol 20 mg
81 Estradiol Pellet Estradiol 20 mg
82 Estradiol Pellet Estradiol 20 mg/1 mg
83 Estradiol Pellet Estradiol 20 mg/1 mg
84 Estradiol Pellet Estradiol 20 mg/20 mg
85 Estradiol Pellet Estradiol 22 mg
86 Estradiol Pellet Estradiol 22 mg
87 Estradiol Pellet Estradiol 22 mg/1 mg
88 Estradiol Pellet Estradiol 22 mg/22 mg
89 Estradiol Pellet Estradiol 25 mg
Page 270 Cite
Suggested Citation:"Appendix F: Compounded Bioidentical Hormone Therapy Formulations with a Single Active Ingredient." National Academies of Sciences, Engineering, and Medicine. 2020. The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25791.
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No. Active Ingredient Present from Listinga Dosage Form All Reported Active Ingredients All Reported Active Ingredient Strengthsb
90 Estradiol Pellet Estradiol 25 mg
91 Estradiol Pellet Estradiol 25 mg
92 Estradiol Pellet Estradiol 25 mg
93 Estradiol Pellet Estradiol 25 mg
94 Estradiol Pellet Estradiol 25 mg/1 mg
95 Estradiol Pellet Estradiol 25 mg/1 mg
96 Estradiol Pellet Estradiol 25 mg/25 mg
97 Estradiol Pellet Estradiol 37.5 mg
98 Estradiol Pellet Estradiol 37.5 mg/37.5 mg
99 Estradiol Pellet Estradiol 50 mg
100 Estradiol Pellet Estradiol 50 mg/50 mg
101 Estradiol Pellet Estradiol 6 mg
102 Estradiol Pellet Estradiol 6 mg
103 Estradiol Pellet Estradiol 6 mg
104 Estradiol Pellet Estradiol 6 mg
105 Estradiol Pellet Estradiol 6 mg
106 Estradiol Pellet Estradiol 6 mg/1 mg
107 Estradiol Pellet Estradiol 6 mg/1 mg
108 Estradiol Pellet Estradiol 6 mg/6 mg
109 Estradiol Pellet Estradiol 75 mg
110 Estradiol Solution Estradiol 0.001
111 Estradiol Suppository Estradiol 1 mg
Page 271 Cite
Suggested Citation:"Appendix F: Compounded Bioidentical Hormone Therapy Formulations with a Single Active Ingredient." National Academies of Sciences, Engineering, and Medicine. 2020. The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25791.
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112 Estriol Capsule Estriol 0.5 mg
113 Estriol Cream Estriol 0.01
114 Estriol Cream Estriol 0.5 mg/1 g
115 Estriol Cream Estriol 0.5 mg/1 g
116 Estriol Cream Estriol 0.5 mg/1 mL
117 Estriol Cream Estriol 0.00025
118 Estriol Cream Estriol 0.0005
119 Estriol Cream Estriol 0.3 mg/1 g; 0.5 mg/1 g; 1.0 mg/1 g
120 Estriol Cream Estriol 1 mg/1 g
121 Estriol Cream Estriol 1 mg/1 g
122 Estriol Cream Estriol 1 mg/1 g
123 Estriol Cream Estriol 1 mg/1 mL
124 Estriol Cream Estriol 1 mg/1 mL
125 Estriol Cream Estriol 1.5 mg/1 mL
126 Estriol Cream Estriol 2 mg/1 g
127 Estriol Cream Estriol 2 mg/1 g
128 Estriol Cream Estriol 2 mg/1 g
129 Estriol Cream Estriol 2.5 mg/1 g
130 Estriol Cream Estriol 3 mg/1 g
131 Estriol Cream Estriol 6 mg/1 g
132 Estriol Gel Estriol 0.2 mg/mL
133 Estriol Gel Estriol 2 mg/mL
134 Estriol Ointment Estriol 0.5 mg/1 g
Page 272 Cite
Suggested Citation:"Appendix F: Compounded Bioidentical Hormone Therapy Formulations with a Single Active Ingredient." National Academies of Sciences, Engineering, and Medicine. 2020. The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25791.
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No. Active Ingredient Present from Listinga Dosage Form All Reported Active Ingredients All Reported Active Ingredient Strengthsb
135 Estriol Ointment Estriol 1 mg/1 g
136 Estriol Ointment Estriol 2 mg/1 g
137 Progesterone Capsule Progesterone 10 mg
138 Progesterone Capsule Progesterone 10 mg
139 Progesterone Capsule Progesterone 100 mg
140 Progesterone Capsule Progesterone 100 mg
141 Progesterone Capsule Progesterone 100 mg
142 Progesterone Capsule Progesterone 100 mg
143 Progesterone Capsule Progesterone 100 mg
144 Progesterone Capsule Progesterone 100 mg
145 Progesterone Capsule Progesterone 100 mg
146 Progesterone Capsule Progesterone 100 mg
147 Progesterone Capsule Progesterone 100 mg
148 Progesterone Capsule Progesterone 100 mg
149 Progesterone Capsule Progesterone 100 mg
150 Progesterone Capsule Progesterone 100 mg
151 Progesterone Capsule Progesterone 12.5 mg
152 Progesterone Capsule Progesterone 120 mg
153 Progesterone Capsule Progesterone 125 mg
154 Progesterone Capsule Progesterone 125 mg
155 Progesterone Capsule Progesterone 125 mg
Page 273 Cite
Suggested Citation:"Appendix F: Compounded Bioidentical Hormone Therapy Formulations with a Single Active Ingredient." National Academies of Sciences, Engineering, and Medicine. 2020. The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25791.
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156 Progesterone Capsule Progesterone 135 mg
157 Progesterone Capsule Progesterone 150 mg
158 Progesterone Capsule Progesterone 150 mg
159 Progesterone Capsule Progesterone 150 mg
160 Progesterone Capsule Progesterone 150 mg
161 Progesterone Capsule Progesterone 150 mg
162 Progesterone Capsule Progesterone 165 mg
163 Progesterone Capsule Progesterone 175 mg
164 Progesterone Capsule Progesterone 175 mg
165 Progesterone Capsule Progesterone 20 mg
166 Progesterone Capsule Progesterone 200 mg
167 Progesterone Capsule Progesterone 200 mg
168 Progesterone Capsule Progesterone 200 mg
169 Progesterone Capsule Progesterone 200 mg
170 Progesterone Capsule Progesterone 200 mg; 100 mg; 50 mg
171 Progesterone Capsule Progesterone 210 mg
172 Progesterone Capsule Progesterone 225 mg
173 Progesterone Capsule Progesterone 25 mg
174 Progesterone Capsule Progesterone 25 mg
175 Progesterone Capsule Progesterone 250 mg
176 Progesterone Capsule Progesterone 300 mg
177 Progesterone Capsule Progesterone 35 mg
178 Progesterone Capsule Progesterone 40 mg
Page 274 Cite
Suggested Citation:"Appendix F: Compounded Bioidentical Hormone Therapy Formulations with a Single Active Ingredient." National Academies of Sciences, Engineering, and Medicine. 2020. The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25791.
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No. Active Ingredient Present from Listinga Dosage Form All Reported Active Ingredients All Reported Active Ingredient Strengthsb
179 Progesterone Capsule Progesterone 40 mg
180 Progesterone Capsule Melatonin; Progesterone 5 mg; 200 mg
181 Progesterone Capsule Progesterone 50 mg
182 Progesterone Capsule Progesterone 50 mg
183 Progesterone Capsule Progesterone 50 mg
184 Progesterone Capsule Progesterone 50 mg
185 Progesterone Capsule Progesterone 50 mg
186 Progesterone Capsule Progesterone 50 mg
187 Progesterone Capsule Progesterone 50 mg
188 Progesterone Capsule Progesterone 50 mg
189 Progesterone Capsule Progesterone 60 mg
190 Progesterone Capsule Progesterone 60 mg
191 Progesterone Capsule Progesterone 75 mg
192 Progesterone Capsule Progesterone 75 mg
193 Progesterone Capsule Progesterone 75 mg
194 Progesterone Capsule Progesterone 80 mg
195 Progesterone Capsule, SR Progesterone 50 mg capsule; 100 mg capsule; 200 mg capsule
196 Progesterone Cream Progesterone 0.05
197 Progesterone Cream Progesterone 0.1
198 Progesterone Cream Progesterone 0.1
199 Progesterone Cream Progesterone 0.1
Page 275 Cite
Suggested Citation:"Appendix F: Compounded Bioidentical Hormone Therapy Formulations with a Single Active Ingredient." National Academies of Sciences, Engineering, and Medicine. 2020. The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25791.
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200 Progesterone Cream Progesterone 0.0065%
201 Progesterone Cream Progesterone 10 mg/1 mL
202 Progesterone Cream Progesterone 100 mg/1 g
203 Progesterone Cream Progesterone 100 mg/1 g
204 Progesterone Cream Progesterone 100 mg/1 mL
205 Progesterone Cream Progesterone 100 mg/1 mL
206 Progesterone Cream Progesterone 120 mg/1 mL
207 Progesterone Cream Progesterone 125 mg/1 mL
208 Progesterone Cream Progesterone 150 mg/1 mL
209 Progesterone Cream Progesterone 160 mg/1 mL
210 Progesterone Cream Progesterone 175 mg/1 mL
211 Progesterone Cream Progesterone 20 mg/0.5 g
212 Progesterone Cream Progesterone 20 mg/0.5 g
213 Progesterone Cream Progesterone 20 mg/1 mL
214 Progesterone Cream Progesterone 20 mg/1 mL
215 Progesterone Cream Progesterone 20 mg/1 mL
216 Progesterone Cream Progesterone 200 mg/1 mL
217 Progesterone Cream Progesterone 200 mg/1 mL
218 Progesterone Cream Progesterone 200 mg/1 mL
219 Progesterone Cream Progesterone 20 mg/0.1 mL
220 Progesterone Cream Progesterone 25 mg/1 mL
221 Progesterone Cream Progesterone 250 mg/1 mL
222 Progesterone Cream Progesterone 25 mg; 50 mg; 75 mg; 100 mg
Page 276 Cite
Suggested Citation:"Appendix F: Compounded Bioidentical Hormone Therapy Formulations with a Single Active Ingredient." National Academies of Sciences, Engineering, and Medicine. 2020. The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25791.
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No. Active Ingredient Present from Listinga Dosage Form All Reported Active Ingredients All Reported Active Ingredient Strengthsb
223 Progesterone Cream Progesterone 30 mg/0.5 g
224 Progesterone Cream Progesterone 30 mg/1 mL
225 Progesterone Cream Progesterone 30 mg/1 mL
226 Progesterone Cream Progesterone 35 mg/1 mL
227 Progesterone Cream Progesterone 40 mg/1 mL
228 Progesterone Cream Progesterone 50 mg/1 mL
229 Progesterone Cream Progesterone 80 mg/1 mL
230 Progesterone Cream Progesterone 80 mg/1 mL
231 Progesterone Cream Progesterone 80 mg/1 mL
232 Progesterone Enema Progesterone —
233 Progesterone Gel Progesterone 0.03
234 Progesterone Gel Progesterone 200 mg/1 mL
235 Progesterone Gel Progesterone 200 mg/mL
236 Progesterone Gel Progesterone 50 mg/mL
237 Progesterone Lozenge Progesterone 10 mg
238 Progesterone Lozenge Progesterone 100 mg
239 Progesterone Lozenge Progesterone 200 mg
240 Progesterone Lozenge Progesterone 200 mg
241 Progesterone Lozenge Progesterone 300 mg
242 Progesterone Lozenge Progesterone 400 mg
243 Progesterone Lozenge Progesterone 5 mg
Page 277 Cite
Suggested Citation:"Appendix F: Compounded Bioidentical Hormone Therapy Formulations with a Single Active Ingredient." National Academies of Sciences, Engineering, and Medicine. 2020. The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25791.
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244 Progesterone Oil Progesterone 60 mg/1 mL
245 Progesterone Pellet Progesterone 100 mg
246 Progesterone Pellet Progesterone 50 mg
247 Progesterone Pellet Progesterone 50 mg
248 Progesterone Pellet Progesterone 75 mg
249 Progesterone Solution Progesterone 100 mg/1 mL
250 Progesterone Solution Progesterone 100 mg/mL
251 Progesterone Solution Progesterone 40 mg/1 mL
252 Progesterone Solution Progesterone 40 mg/1 mL
253 Progesterone Solution Progesterone 50 mg/mL
254 Progesterone Spray Progesterone 0.02
255 Progesterone Suppository Progesterone —
256 Progesterone Suppository Progesterone —
257 Progesterone Suppository Progesterone 100 mg
258 Progesterone Suppository Progesterone 100 mg; 200 mg
259 Progesterone Suppository Progesterone 200 mg
260 Progesterone Suppository Progesterone 45 mg
261 Progesterone Suppository Progesterone 50 mg
262 Progesterone Suppository Progesterone 50 mg/mL
263 Progesterone Suppository Progesterone 50 mg; 100 mg; 200 mg
264 Progesterone Suspension Progesterone 200 mg/mL
265 Progesterone Suspension Progesterone 40 mg/mL
266 Progesterone Tablet Progesterone 200 mg
Page 278 Cite
Suggested Citation:"Appendix F: Compounded Bioidentical Hormone Therapy Formulations with a Single Active Ingredient." National Academies of Sciences, Engineering, and Medicine. 2020. The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25791.
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No. Active Ingredient Present from Listinga Dosage Form All Reported Active Ingredients All Reported Active Ingredient Strengthsb
267 Testosterone Capsule Testosterone 25 mg
268 Testosterone Cream Testosterone 0.3 mg/1 mL
269 Testosterone Cream Testosterone 0.5 mg/1 mL
270 Testosterone Cream Testosterone 0.5 mg; 1 mg; 2 mg; 3 mg
271 Testosterone Cream Testosterone 1 mg/1 mL
272 Testosterone Cream Testosterone 1.1 mg/1 mL
273 Testosterone Cream Testosterone 1.75 mg/1 mL
274 Testosterone Cream Testosterone 1.75 mg/1 mL
275 Testosterone Cream Testosterone 1.9 mg/1 mL
276 Testosterone Cream Testosterone 10 mg/1 g
277 Testosterone Cream Sildenafil Citrate; Testosterone 10 mg/1 g; 10 mg/1 g
278 Testosterone Cream Sildenafil Citrate; Arginine Hydrochloride; Testosterone; Ergoloid Mesylates; Pentoxifylline; Aminophylline 10 mg/1 g; 60 mg/1 g; 1 mg/1 g; 0.5 mg/1 g; 50 mg/1 g; 30 mg/1 g
279 Testosterone Cream Testosterone 10 mg/1 mL
280 Testosterone Cream Testosterone 100 mg/1 g
281 Testosterone Cream Testosterone 12 mg/1 mL
282 Testosterone Cream Testosterone 2 mg/1 mL
283 Testosterone Cream Testosterone 2.5 mg/1 g
284 Testosterone Cream Testosterone 2.5 mg/1 mL
285 Testosterone Cream Testosterone 20 mg/1 mL
286 Testosterone Cream Testosterone 20 mg/1 mL
Page 279 Cite
Suggested Citation:"Appendix F: Compounded Bioidentical Hormone Therapy Formulations with a Single Active Ingredient." National Academies of Sciences, Engineering, and Medicine. 2020. The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25791.
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287 Testosterone Cream Testosterone 200 mg/1 mL
288 Testosterone Cream Testosterone 3 mg/1 mL
289 Testosterone Cream Testosterone 3.5 mg/1 mL
290 Testosterone Cream Testosterone 4 mg/1 mL
291 Testosterone Cream Testosterone 40 mg/1 mL
292 Testosterone Cream Testosterone 5 mg/1 g
293 Testosterone Cream Testosterone 7.5 mg/1 mL
294 Testosterone Cream Testosterone 75 mg/1 g
295 Testosterone Cream Testosterone 8 mg/1 g
296 Testosterone Cream Testosterone 8 mg/1 mL
297 Testosterone Gel Testosterone 0.5 mg/1 mL
298 Testosterone Gel Testosterone 1 mg/0.1 mL
299 Testosterone Gel Testosterone 1 mg/0.1 mL
300 Testosterone Gel Testosterone 1 mg/1 g
301 Testosterone Gel Testosterone 1 mg/1 mL
302 Testosterone Gel Testosterone 1.25 mg/1 mL
303 Testosterone Gel Testosterone 1.5 mg/1 mL
304 Testosterone Gel Testosterone 100 mg/1 g
305 Testosterone Gel Testosterone 100 mg/1 g
306 Testosterone Gel Testosterone 100 mg/1 mL
307 Testosterone Gel Testosterone 100 mg/1 mL
308 Testosterone Gel Testosterone 12 mg/1 mL
309 Testosterone Gel Testosterone 2 mg/1 mL
Page 280 Cite
Suggested Citation:"Appendix F: Compounded Bioidentical Hormone Therapy Formulations with a Single Active Ingredient." National Academies of Sciences, Engineering, and Medicine. 2020. The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25791.
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No. Active Ingredient Present from Listinga Dosage Form All Reported Active Ingredients All Reported Active Ingredient Strengthsb
310 Testosterone Gel Testosterone 2.5 mg/1 mL
311 Testosterone Gel Testosterone 25 mg/1 mL
312 Testosterone Gel Testosterone 3 mg/1 mL
313 Testosterone Gel Testosterone 30 mg/1 mL
314 Testosterone Gel Testosterone 4 mg/1 mL
315 Testosterone Gel Testosterone 40 mg/1 mL
316 Testosterone Gel Testosterone 5 mg/1 mL
317 Testosterone Gel Testosterone 50 mg/1 g
318 Testosterone Gel Testosterone 50 mg/1 g
319 Testosterone Gel Testosterone 50 mg/1 g
320 Testosterone Gel Testosterone 50 mg/1 mL
321 Testosterone Gel Testosterone 50 mg/mL
322 Testosterone Gel Testosterone 6 mg/1 mL
323 Testosterone Gel Testosterone 8 mg/1 mL
324 Testosterone Lotion Testosterone 0.02
325 Testosterone Lozenge Testosterone 0.625 mg
326 Testosterone Lozenge Testosterone 1–10 mg
327 Testosterone Lozenge Testosterone 10 mg
328 Testosterone Lozenge Testosterone 1 mg
329 Testosterone Lozenge Testosterone 2 mg
330 Testosterone Lozenge Testosterone 3 mg
331 Testosterone Ointment Testosterone; Menthol 0.02
Page 281 Cite
Suggested Citation:"Appendix F: Compounded Bioidentical Hormone Therapy Formulations with a Single Active Ingredient." National Academies of Sciences, Engineering, and Medicine. 2020. The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25791.
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332 Testosterone Ointment Testosterone; Menthol 0.02
333 Testosterone Ointment Testosterone 10 mg/1 g
334 Testosterone Ointment Testosterone 20 mg/1 g
335 Testosterone Pellet Testosterone 100 mg
336 Testosterone Pellet Testosterone 100 mg
337 Testosterone Pellet Testosterone 100 mg
338 Testosterone Pellet Testosterone 100 mg
339 Testosterone Pellet Testosterone 100 mg
340 Testosterone Pellet Testosterone 100 mg
341 Testosterone Pellet Testosterone 100 mg
342 Testosterone Pellet Testosterone 100 mg
343 Testosterone Pellet Testosterone 100 mg/1 mg
344 Testosterone Pellet Testosterone 100 mg/1 mg
345 Testosterone Pellet Testosterone 100 mg/100 mg
346 Testosterone Pellet Testosterone; Anastrozole 100 mg; 4 mg
347 Testosterone Pellet Testosterone 12.5 mg
348 Testosterone Pellet Testosterone 12.5 mg
349 Testosterone Pellet Testosterone 12.5 mg
350 Testosterone Pellet Testosterone 12.5 mg
351 Testosterone Pellet Testosterone 12.5 mg
352 Testosterone Pellet Testosterone 12.5 mg
353 Testosterone Pellet Testosterone 12.5 mg/1 mg
354 Testosterone Pellet Testosterone 12.5 mg/1 mg
Page 282 Cite
Suggested Citation:"Appendix F: Compounded Bioidentical Hormone Therapy Formulations with a Single Active Ingredient." National Academies of Sciences, Engineering, and Medicine. 2020. The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25791.
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No. Active Ingredient Present from Listinga Dosage Form All Reported Active Ingredients All Reported Active Ingredient Strengthsb
355 Testosterone Pellet Testosterone 12.5 mg/1 mg
356 Testosterone Pellet Testosterone 18 mg
357 Testosterone Pellet Testosterone 18 mg
358 Testosterone Pellet Testosterone 18 mg/18 mg
359 Testosterone Pellet Testosterone 200 mg
360 Testosterone Pellet Testosterone 200 mg
361 Testosterone Pellet Testosterone 200 mg
362 Testosterone Pellet Testosterone 200 mg
363 Testosterone Pellet Testosterone 200 mg
364 Testosterone Pellet Testosterone 200 mg
365 Testosterone Pellet Testosterone 200 mg
366 Testosterone Pellet Testosterone 200 mg
367 Testosterone Pellet Testosterone 200 mg
368 Testosterone Pellet Testosterone 200 mg
369 Testosterone Pellet Testosterone 200 mg/1 mg
370 Testosterone Pellet Testosterone 200 mg/1 mg
371 Testosterone Pellet Testosterone 200 mg/200 mg
372 Testosterone Pellet Testosterone; Anastrozole 200 mg; 20 mg
373 Testosterone Pellet Testosterone; Anastrozole 200 mg; 20 mg
374 Testosterone Pellet Testosterone 25 mg
375 Testosterone Pellet Testosterone 25 mg
376 Testosterone Pellet Testosterone 25 mg
Page 283 Cite
Suggested Citation:"Appendix F: Compounded Bioidentical Hormone Therapy Formulations with a Single Active Ingredient." National Academies of Sciences, Engineering, and Medicine. 2020. The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25791.
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377 Testosterone Pellet Testosterone 25 mg
378 Testosterone Pellet Testosterone 25 mg
379 Testosterone Pellet Testosterone 25 mg
380 Testosterone Pellet Testosterone 25 mg/1 mg
381 Testosterone Pellet Testosterone 25 mg/1 mg
382 Testosterone Pellet Testosterone 25 mg/25 mg
383 Testosterone Pellet Testosterone 37.5 mg
384 Testosterone Pellet Testosterone 37.5 mg
385 Testosterone Pellet Testosterone 37.5 mg
386 Testosterone Pellet Testosterone 37.5 mg
387 Testosterone Pellet Testosterone 37.5 mg
388 Testosterone Pellet Testosterone 37.5 mg
389 Testosterone Pellet Testosterone 37.5 mg/1 mg
390 Testosterone Pellet Testosterone 37.5 mg/37.5 mg
391 Testosterone Pellet Anastrozole; Testosterone 4 mg/1 mg; 100 mg/1 mg
392 Testosterone Pellet Anastrozole; Testosterone 4 mg/1 mg; 60 mg/1 mg
393 Testosterone Pellet Anastrozole; Testosterone 4 mg/1 mg; 75 mg/1 mg
394 Testosterone Pellet Testosterone 40 mg/40 mg
395 Testosterone Pellet Testosterone 50 mg
396 Testosterone Pellet Testosterone 50 mg
397 Testosterone Pellet Testosterone 50 mg
398 Testosterone Pellet Testosterone 50 mg
399 Testosterone Pellet Testosterone 50 mg
Page 284 Cite
Suggested Citation:"Appendix F: Compounded Bioidentical Hormone Therapy Formulations with a Single Active Ingredient." National Academies of Sciences, Engineering, and Medicine. 2020. The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25791.
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No. Active Ingredient Present from Listinga Dosage Form All Reported Active Ingredients All Reported Active Ingredient Strengthsb
400 Testosterone Pellet Testosterone 50 mg
401 Testosterone Pellet Testosterone 50 mg/1 mg
402 Testosterone Pellet Testosterone 50 mg/1 mg
403 Testosterone Pellet Testosterone 50 mg/50 mg
404 Testosterone Pellet Testosterone 55 mg/55 mg
405 Testosterone Pellet Testosterone 60 mg/1 mg
406 Testosterone Pellet Testosterone; Anastrozole 60 mg; 4 mg
407 Testosterone Pellet Testosterone 62.5 mg
408 Testosterone Pellet Testosterone 62.5 mg
409 Testosterone Pellet Testosterone 62.5 mg
410 Testosterone Pellet Testosterone 70 mg
411 Testosterone Pellet Testosterone 70 mg
412 Testosterone Pellet Testosterone; Anastrozole 75 mg; 4 mg
413 Testosterone Pellet Anastrozole; Testosterone 8 mg/1 mg; 100 mg/1 mg
414 Testosterone Pellet Anastrozole; Testosterone 8 mg/1 mg; 100 mg/1 mg
415 Testosterone Pellet Testosterone 80 mg
416 Testosterone Pellet Testosterone 80 mg
417 Testosterone Pellet Testosterone 80 mg
418 Testosterone Pellet Testosterone 80 mg
419 Testosterone Pellet Testosterone 80 mg
420 Testosterone Pellet Testosterone 80 mg/1 mg
421 Testosterone Pellet Testosterone 87.5 mg
Page 285 Cite
Suggested Citation:"Appendix F: Compounded Bioidentical Hormone Therapy Formulations with a Single Active Ingredient." National Academies of Sciences, Engineering, and Medicine. 2020. The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25791.
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422 Testosterone Pellet Testosterone 87.5 mg
423 Testosterone Pellet Testosterone 87.5 mg
424 Testosterone Pellet Testosterone 87.5 mg
425 Testosterone Pellet Testosterone 87.5 mg
426 Testosterone Pellet Testosterone 87.5 mg/1 mg
427 Testosterone Pellet Testosterone 87.5 mg/1 mg
428 Testosterone Pellet Testosterone 87.5 mg/87.5 mg
429 Testosterone Solution Testosterone 10 mg/0.1 mL
430 Testosterone Solution Testosterone 25 mg/0.25 mL
431 Testosterone Solution Testosterone 5 mg/1 mL
432 Testosterone Solution Testosterone 50 mg/1 mL
433 Testosterone Spray Testosterone 1 mg/0.1 mL
434 Testosterone Spray Testosterone 1 mg/0.1 mL
435 Testosterone Cypionate Injection Testosterone Cypionate 0.2 g/1,000 g
436 Testosterone Cypionate Injection Testosterone Cypionate 0.2 g/1,000 g
437 Testosterone Cypionate Injection Testosterone Cypionate 0.2 g/1,000 g
438 Testosterone Cypionate Injection Testosterone Cypionate 100 mg/1 mL
439 Testosterone Cypionate Injection Testosterone Cypionate 100 mg/mL
440 Testosterone Cypionate Injection Testosterone Cypionate 150 mg/1 mL
441 Testosterone Cypionate Injection Testosterone Cypionate 200 mg/1 mL
442 Testosterone Cypionate Injection Testosterone Cypionate 200 mg/1 mL
443 Testosterone Cypionate Injection Testosterone Cypionate 200 mg/1 mL
444 Testosterone Cypionate Injection Testosterone Cypionate 200 mg/1 mL
Page 286 Cite
Suggested Citation:"Appendix F: Compounded Bioidentical Hormone Therapy Formulations with a Single Active Ingredient." National Academies of Sciences, Engineering, and Medicine. 2020. The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25791.
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No. Active Ingredient Present from Listinga Dosage Form All Reported Active Ingredients All Reported Active Ingredient Strengthsb
445 Testosterone Cypionate Injection Testosterone Cypionate 200 mg/1 mL
446 Testosterone Cypionate Injection Testosterone Cypionate 200 mg/1 mL
447 Testosterone Cypionate Injection Testosterone Cypionate 200 mg/1 mL
448 Testosterone Cypionate Injection Testosterone Cypionate 200 mg/1 mg
449 Testosterone Cypionate Injection Testosterone Cypionate 200 mg/1 mg
450 Testosterone Cypionate Injection Testosterone Cypionate 200 mg/1 mg
451 Testosterone Cypionate Injection Testosterone Cypionate 200 mg/200 mg
452 Testosterone Cypionate Injection Testosterone Cypionate 50 mg/1 mL
453 Testosterone Cypionate Injection Testosterone Enanthate; Testosterone Cypionate; Nandrolone Decanoate 70 mg/1 mL; 70 mg/1 mL; 60 mg/1 mL
454 Testosterone Propionate Cream Testosterone Propionate 100 mg/6 mL
455 Testosterone Propionate Cream Testosterone Propionate 20 mg/1 g
456 Testosterone Propionate Cream Testosterone Propionate 20 mg/1 g
457 Testosterone Propionate Cream Testosterone Propionate 20 mg/1 mL
458 Testosterone Propionate Gel Testosterone Propionate
459 Testosterone Propionate Injection Testosterone Propionate 100 mg/1 mL
460 Testosterone Propionate Injection Testosterone Propionate 100 mg/mL
461 Testosterone Propionate Ointment Testosterone Propionate 0.02
462 Testosterone Propionate Ointment Testosterone Propionate 20 mg/1 g

a Under “Active Ingredient Present from Listing,” for combination products, methyltestosterone and testosterone enanthate are categorized as testosterone, and 7-keto-dehydroepiandrosterone as dehydroepiandrosterone.

b Under “All Reported Active Ingredient Strengths,” if field is blank, ingredient strengths and/or units were not reported.

Page 287 Cite
Suggested Citation:"Appendix F: Compounded Bioidentical Hormone Therapy Formulations with a Single Active Ingredient." National Academies of Sciences, Engineering, and Medicine. 2020. The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25791.
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NOTE: Resources included peer-reviewed literature on use of cBHT (e.g., IJPC, 2018), cBHT preparation adverse event reports (FDA, 2018, 2020), information provided by compounding practitioners (see the National Academies Public Access File), recent biannual outsourcing facility preparation reports (FDA, 2019), and online marketing information from compounding pharmacies.

REFERENCES

FDA (U.S. Food and Drug Administration). 2018. MedWatch. https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program (accessed June 3, 2020).

FDA. 2019. Email from G. Cosel to National Academies staff regarding aggregated volume output of products containing ingredients of interest to compounded bioidentical hormone therapy study. May 30, 2020 (available through the National Academies Public Access File).

FDA. 2020. Compounding: Inspections, recalls, and other actions. https://www.fda.gov/drugs/human-drug-compounding/compounding-inspections-recalls-and-other-actions (accessed January 4, 2020).

IJPC (International Journal of Pharmaceutical Compounding). 2018. Compounding for bioidentical hormone replacement therapy patients. Purchased compiled peer-reviewed articles from 1997–2018. In IJPC. Edmond, OK: IJPC.

Page 288 Cite
Suggested Citation:"Appendix F: Compounded Bioidentical Hormone Therapy Formulations with a Single Active Ingredient." National Academies of Sciences, Engineering, and Medicine. 2020. The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25791.
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Suggested Citation:"Appendix F: Compounded Bioidentical Hormone Therapy Formulations with a Single Active Ingredient." National Academies of Sciences, Engineering, and Medicine. 2020. The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25791.
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Suggested Citation:"Appendix F: Compounded Bioidentical Hormone Therapy Formulations with a Single Active Ingredient." National Academies of Sciences, Engineering, and Medicine. 2020. The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25791.
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Suggested Citation:"Appendix F: Compounded Bioidentical Hormone Therapy Formulations with a Single Active Ingredient." National Academies of Sciences, Engineering, and Medicine. 2020. The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25791.
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Suggested Citation:"Appendix F: Compounded Bioidentical Hormone Therapy Formulations with a Single Active Ingredient." National Academies of Sciences, Engineering, and Medicine. 2020. The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25791.
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Suggested Citation:"Appendix F: Compounded Bioidentical Hormone Therapy Formulations with a Single Active Ingredient." National Academies of Sciences, Engineering, and Medicine. 2020. The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25791.
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Suggested Citation:"Appendix F: Compounded Bioidentical Hormone Therapy Formulations with a Single Active Ingredient." National Academies of Sciences, Engineering, and Medicine. 2020. The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25791.
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Suggested Citation:"Appendix F: Compounded Bioidentical Hormone Therapy Formulations with a Single Active Ingredient." National Academies of Sciences, Engineering, and Medicine. 2020. The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25791.
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Suggested Citation:"Appendix F: Compounded Bioidentical Hormone Therapy Formulations with a Single Active Ingredient." National Academies of Sciences, Engineering, and Medicine. 2020. The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25791.
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Suggested Citation:"Appendix F: Compounded Bioidentical Hormone Therapy Formulations with a Single Active Ingredient." National Academies of Sciences, Engineering, and Medicine. 2020. The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25791.
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Suggested Citation:"Appendix F: Compounded Bioidentical Hormone Therapy Formulations with a Single Active Ingredient." National Academies of Sciences, Engineering, and Medicine. 2020. The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25791.
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Suggested Citation:"Appendix F: Compounded Bioidentical Hormone Therapy Formulations with a Single Active Ingredient." National Academies of Sciences, Engineering, and Medicine. 2020. The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25791.
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Suggested Citation:"Appendix F: Compounded Bioidentical Hormone Therapy Formulations with a Single Active Ingredient." National Academies of Sciences, Engineering, and Medicine. 2020. The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25791.
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Suggested Citation:"Appendix F: Compounded Bioidentical Hormone Therapy Formulations with a Single Active Ingredient." National Academies of Sciences, Engineering, and Medicine. 2020. The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25791.
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Suggested Citation:"Appendix F: Compounded Bioidentical Hormone Therapy Formulations with a Single Active Ingredient." National Academies of Sciences, Engineering, and Medicine. 2020. The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25791.
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Suggested Citation:"Appendix F: Compounded Bioidentical Hormone Therapy Formulations with a Single Active Ingredient." National Academies of Sciences, Engineering, and Medicine. 2020. The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25791.
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Suggested Citation:"Appendix F: Compounded Bioidentical Hormone Therapy Formulations with a Single Active Ingredient." National Academies of Sciences, Engineering, and Medicine. 2020. The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25791.
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Suggested Citation:"Appendix F: Compounded Bioidentical Hormone Therapy Formulations with a Single Active Ingredient." National Academies of Sciences, Engineering, and Medicine. 2020. The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25791.
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Suggested Citation:"Appendix F: Compounded Bioidentical Hormone Therapy Formulations with a Single Active Ingredient." National Academies of Sciences, Engineering, and Medicine. 2020. The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25791.
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Suggested Citation:"Appendix F: Compounded Bioidentical Hormone Therapy Formulations with a Single Active Ingredient." National Academies of Sciences, Engineering, and Medicine. 2020. The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25791.
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Suggested Citation:"Appendix F: Compounded Bioidentical Hormone Therapy Formulations with a Single Active Ingredient." National Academies of Sciences, Engineering, and Medicine. 2020. The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25791.
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Suggested Citation:"Appendix F: Compounded Bioidentical Hormone Therapy Formulations with a Single Active Ingredient." National Academies of Sciences, Engineering, and Medicine. 2020. The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25791.
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Suggested Citation:"Appendix F: Compounded Bioidentical Hormone Therapy Formulations with a Single Active Ingredient." National Academies of Sciences, Engineering, and Medicine. 2020. The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25791.
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Suggested Citation:"Appendix F: Compounded Bioidentical Hormone Therapy Formulations with a Single Active Ingredient." National Academies of Sciences, Engineering, and Medicine. 2020. The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25791.
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Suggested Citation:"Appendix F: Compounded Bioidentical Hormone Therapy Formulations with a Single Active Ingredient." National Academies of Sciences, Engineering, and Medicine. 2020. The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use. Washington, DC: The National Academies Press. doi: 10.17226/25791.
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The U.S. Food and Drug Administration (FDA) has approved dozens of hormone therapy products for men and women, including estrogen, progesterone, testosterone, and related compounds. These products have been reviewed for safety and efficacy and are indicated for treatment of symptoms resulting from hormonal changes associated with menopause or other endocrine-based disorders. In recent decades, an increasing number of health care providers and patients have turned to custom-formulated, or compounded, drug preparations as an alternative to FDA-approved drug products for hormone-related health concerns. These compounded hormone preparations are often marketed as "bioidentical" or "natural" and are commonly referred to as compounded bioidentical hormone therapy (cBHT).

In light of the fast-growing popularity of cBHT preparations, the clinical utility of these compounded preparations is a substantial public health concern for various stakeholders, including medical practitioners, patients, health advocacy organizations, and federal and state public health agencies. This report examines the clinical utility and uses of cBHT drug preparations and reviews the available evidence that would support marketing claims of the safety and effectiveness of cBHT preparations. It also assesses whether the available evidence suggests that these preparations have clinical utility and safety profiles warranting their clinical use and identifies patient populations that might benefit from cBHT preparations in lieu of FDA-approved BHT.

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