HRT Compounding & Bioidentical Hormones 2

Question 1

Under which section of the Federal Food, Drug, and Cosmetic Act is traditional pharmacy compounding regulated?

Accepted Answer

Section 503A

Answer

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?

Accepted Answer

Lack of mandatory pre-market testing for potency, sterility, and consistency

Answer

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?

Accepted Answer

PCAB (Pharmacy Compounding Accreditation Board)

Answer

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?

Accepted Answer

Non-sterile compounding standards

Answer

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?

Accepted Answer

An FDA-approved bioidentical hormone product

Answer

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.

HRT - Hormone Replacement Therapy Certification Practice Test

HRT - Hormone Replacement Therapy Certification Practice Test

HRT Compounding & Bioidentical Hormones 2