Compounding with Sarah

Topical Management of Alopecia Sarah Taylor, PharmD Alopecia affects a significant number of Americans. One study of men between the ages of 18 to 49, found that 42% of the men had moderate to extensive hair loss. ' Hair loss is less prevalent in women and has a reported incidence of between 29 to 38% in women over 70 years of age. 2 There are a variety of different pathologies that can contribute to hair loss including noncicatricial alopecias such as androgenic alopecia, alopecia areata, and telogen effluvium as well as cicatricial alopecias such as lichen planopilaris.   Androgenetic alopecia is the most prevalent form of hair loss in both men and women. 3 In this newsletter, we will focus on noncicatricial alopecias and review topical treatments and their evidence for efficacy for various types of hair loss.   The most common variety of hair loss, androgenetic alopecia, has been well studied. It can be precipitated by acute stressors,...

  Testosterone Replacement and Hypogonadism: A Brief Review of APIs that Modify Testosterone’s Metabolism in the Body Testosterone replacement therapy is currently the standard of treatment for hypogonadism, however, testosterone replacement alone is not always sufficient due to the multiple metabolic pathways involved in the transformation or breakdown of testosterone. 1 Testosterone is converted to estradiol via aromatase. Estrogens such as estradiol generate negative feedback to the hypothalamus and pituitary gland reducing the amount of follicle stimulating hormone (FSH) and luteinizing hormone (LH) secreted. This negative feedback loop resulting in reduction of FSH and LH (gonadotropins) decreases testosterone production which can compromise the utility of testosterone therapy alone for hypogonadism. 1 Adjunct therapies such as aromatase inhibitors (anastrozole, letrozole etc.) or estrogen receptor antagonists ( clomiphene, enclomiphene, tamoxifen , etc.), or GNRH antagoni...

  Regulatory Update – June 8, 2022 Meeting of the Pharmacy Compounding Advisory Committee (PCAC) What is the Pharmacy Compounding Advisory Committee? The Pharmacy Compounding Advisory Committee (PCAC) provides advice to the Food and Drug Administration (FDA) regarding scientific, technical, and medical issues that pertain to sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act).   What is the significance of the upcoming PCAC meeting ? 1 Currently, pharmacies operating under section 503A of the FD&C Act may only compound with a bulk drug substance if it meets one of the following three requirements [JHMI1]   : 1. Comply with an applicable United States Pharmacopeia (USP) or National Formulary (NF) monograph if one exists, and the USP chapter on pharmacy compounding; 2. Are components of FDA-approved drug products if an applicable USP or NF monograph does not exist; or 3. Appear on FDA’s list of bulk drug substances that can ...