HRT Compounding & Bioidentical Hormones 2 — Questions and Answers
Question 1: Under which section of the Federal Food, Drug, and Cosmetic Act is traditional pharmacy compounding regulated?
- Section 503A (Correct answer)
- Section 501B
- Section 404C
- Section 602D
Correct answer: Section 503A
Section 503A of the FD&C Act governs traditional pharmacy compounding, exempting qualifying pharmacies from certain FDA requirements when compounding pursuant to a valid individual patient prescription.
Question 2: What is the primary quality concern with compounded hormone preparations that the FDA has identified?
- Lack of mandatory pre-market testing for potency, sterility, and consistency (Correct answer)
- Compounded products are always stronger than commercial equivalents
- State pharmacies are prohibited from compounding more than 10 hormone products
- Compounded hormones can only be legally dispensed in cream form
Correct answer: Lack of mandatory pre-market testing for potency, sterility, and consistency
Because compounded preparations are not subject to the same FDA pre-market testing as commercial drugs, there are ongoing concerns about consistency in potency, sterility, and overall quality control.
Question 3: Which organization provides voluntary accreditation to compounding pharmacies to demonstrate adherence to quality standards?
- PCAB (Pharmacy Compounding Accreditation Board) (Correct answer)
- JCAHO (The Joint Commission)
- NABP (National Association of Boards of Pharmacy)
- ASHP (American Society of Health-System Pharmacists)
Correct answer: PCAB (Pharmacy Compounding Accreditation Board)
PCAB provides voluntary accreditation to compounding pharmacies, signaling to prescribers and patients that the pharmacy adheres to established quality and safety standards beyond minimum legal requirements.
Question 4: USP <795> in compounding pharmacies primarily addresses which type of preparation?
- Non-sterile compounding standards (Correct answer)
- Sterile compounding standards
- Radiopharmaceutical preparation guidelines
- Controlled substance handling procedures
Correct answer: Non-sterile compounding standards
USP <795> provides standards for non-sterile compounding, covering ingredient quality, beyond-use dating, environmental monitoring, and facility requirements for preparations that do not require sterility.
Question 5: Prometrium (micronized progesterone) is best classified as which type of hormone preparation?
- A synthetic progestin
- An FDA-approved bioidentical hormone product (Correct answer)
- A compounded bioidentical hormone
- A conjugated equine progestin
Correct answer: An FDA-approved bioidentical hormone product
Prometrium is an FDA-approved bioidentical hormone product that is chemically identical to endogenous progesterone; it undergoes FDA review and is commercially manufactured, not compounded.
Question 6: What is a 'beyond-use date' (BUD) as applied to compounded hormone preparations?
- The date after which the compounded preparation should not be used (Correct answer)
- The date the raw ingredients were manufactured
- The date the prescription was written by the prescriber
- The expiration date stamped on the raw ingredient container
Correct answer: The date after which the compounded preparation should not be used
The beyond-use date (BUD) is the date after which a compounded preparation should be discarded, determined by the pharmacist using USP guidelines, formulation data, and storage conditions.
Question 7: Which of the three primary endogenous estrogens is the weakest and is often highlighted in BHRT for its potentially favorable safety profile?
- Estrone (E1)
- Estradiol (E2)
- Estriol (E3) (Correct answer)
- Ethinyl estradiol
Correct answer: Estriol (E3)
Estriol (E3) is the weakest of the three main endogenous estrogens and is frequently emphasized in BHRT discussions because it may have lower stimulatory effects on breast tissue compared to estradiol.
HRT Compounding & Bioidentical Hormones 2
Under which section of the Federal Food, Drug, and Cosmetic Act is traditional pharmacy compounding regulated?