Page 265 Cite Bookmark

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.

Appendix F

Compounded Bioidentical Hormone Therapy Formulations with a Single Active Ingredient

Page 266 Cite Bookmark

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.

No.	Active Ingredient Present from Listing^a	Dosage Form	All Reported Active Ingredients	All Reported Active Ingredient Strengths^b
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 Bookmark

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.

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 Bookmark

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.

No.	Active Ingredient Present from Listing^a	Dosage Form	All Reported Active Ingredients	All Reported Active Ingredient Strengths^b
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 Bookmark

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.

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 Bookmark

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.

No.	Active Ingredient Present from Listing^a	Dosage Form	All Reported Active Ingredients	All Reported Active Ingredient Strengths^b
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 Bookmark

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.

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 Bookmark

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.

No.	Active Ingredient Present from Listing^a	Dosage Form	All Reported Active Ingredients	All Reported Active Ingredient Strengths^b
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 Bookmark

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.

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 Bookmark

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.

No.	Active Ingredient Present from Listing^a	Dosage Form	All Reported Active Ingredients	All Reported Active Ingredient Strengths^b
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 Bookmark

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.

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 Bookmark

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.

No.	Active Ingredient Present from Listing^a	Dosage Form	All Reported Active Ingredients	All Reported Active Ingredient Strengths^b
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 Bookmark

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.

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 Bookmark

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.

No.	Active Ingredient Present from Listing^a	Dosage Form	All Reported Active Ingredients	All Reported Active Ingredient Strengths^b
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 Bookmark

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.

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 Bookmark

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.

No.	Active Ingredient Present from Listing^a	Dosage Form	All Reported Active Ingredients	All Reported Active Ingredient Strengths^b
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 Bookmark

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.

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 Bookmark

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.

No.	Active Ingredient Present from Listing^a	Dosage Form	All Reported Active Ingredients	All Reported Active Ingredient Strengths^b
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 Bookmark

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.

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 Bookmark

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.

No.	Active Ingredient Present from Listing^a	Dosage Form	All Reported Active Ingredients	All Reported Active Ingredient Strengths^b
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 Bookmark

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.

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 Bookmark

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.

No.	Active Ingredient Present from Listing^a	Dosage Form	All Reported Active Ingredients	All Reported Active Ingredient Strengths^b
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 Bookmark

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.

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 Bookmark

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 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

Appendix F

Compounded Bioidentical Hormone Therapy Formulations with a Single Active Ingredient

REFERENCES

My Academies

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

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

REFERENCES

Appendix F

Compounded Bioidentical Hormone Therapy Formulations with a Single Active Ingredient