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89 FR (10/25/2024) » 2024-24828. Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Bulk Drug Substances Nominated for Inclusion on the Section 503A Bulk Drug Substances List
2024-24828. Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Bulk Drug Substances Nominated for Inclusion on the Section 503A Bulk Drug Substances List
Bulk drug substance |
Uses evaluated |
AOD-9604 (free base) |
*Obesity. |
AOD-9604 Acetate |
|
CJC-1295 (free base) |
Growth hormone deficiency. |
CJC-1295 Acetate |
|
CJC-1295 DAC (free base) |
|
CJC-1295 DAC Acetate |
|
CJC-1295 DAC Trifluoroacetate |
|
Thymosin alpha-1(free base) |
Hepatitis B. |
Thymosin alpha-1 Acetate |
Hepatitis C. |
|
Human immunodeficiency virus (HIV). |
|
Coronavirus disease 2019 (COVID-19). |
|
Depressed response to vaccinations; adjuvant to flu vaccines. |
|
Malignant melanoma. |
|
Hepatocellular carcinoma (HCC). |
|
Non-small cell lung cancer (NSCLC). |
|
Sepsis. |
|
Infections after hematopoietic stem cell transplantation (HSCT). |
|
Chronic obstructive pulmonary disease (COPD). |
|
Myalgic encephalomyelitis and chronic fatigue syndrome (ME/CFS). |
Document Information
- Published:
- 10/25/2024
- Department:
- Food and Drug Administration
- Entry Type:
- Notice
- Action:
- Notice; establishment of a public docket; request for comments.
- Document Number:
- 2024-24828
- Dates:
- The meeting will be held on December 4, 2024, from 8 a.m. to 3 p.m. Eastern Time.
- Pages:
- 85219-85221 (3 pages)
- Docket Numbers:
- Docket No. FDA-2024-N-4777
- PDF File:
-
2024-24828.pdf