Reed Smith In-depth

The Pharmacy Compounding Advisory Committee (PCAC) convened on June 8, 2022 to review four bulk drug substances nominated for inclusion on the final 503A Bulks List under section 503A of the Food, Drug, and Cosmetic Act (FDCA).

Based on the information presented by the Food and Drug Administration (FDA) and the nominators of the substances:

  • PCAC voted for the inclusion of glutathione on the final 503A Bulks List.
    • Glutathione was evaluated for use in the treatment of a number of conditions, including but not limited to, skin lightening, cystic fibrosis, asthma, chronic obstructive pulmonary disease, chronic lung disease, oxidative stress, and the reduction of the side effects of chemotherapy.
  • PCAC voted against the inclusion of ammonium tetrathiomolybdate, enclomiphene citrate, and ferric subsulfate on the final 503A Bulks List.
    • Ammonium tetrathiomolybdate was evaluated for use in the treatment of Wilson’s disease and for use as copper chelation therapy for the treatment of breast cancer, kidney cancer, prostate cancer, colorectal cancer, esophageal cancer, and malignant pleural mesothelioma.
    • Enclomiphene citrate was evaluated for use to increase serum testosterone, luteinizing hormone, and follicle-stimulating hormone to normal levels in the treatment of secondary hypogonadism.
    • Ferric subsulfate was evaluated for use as an astringent and hemostatic agent during minor surgical procedures.