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 501B

Answer

Section 404C

Answer

Section 602D

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

Compounded products are always stronger than commercial equivalents

Answer

State pharmacies are prohibited from compounding more than 10 hormone products

Answer

Compounded hormones can only be legally dispensed in cream form

Question 3

Which organization provides voluntary accreditation to compounding pharmacies to demonstrate adherence to quality standards?

Accepted Answer

PCAB (Pharmacy Compounding Accreditation Board)

Answer

JCAHO (The Joint Commission)

Answer

NABP (National Association of Boards of Pharmacy)

Answer

ASHP (American Society of Health-System Pharmacists)

Question 4

USP <795> in compounding pharmacies primarily addresses which type of preparation?

Accepted Answer

Non-sterile compounding standards

Answer

Sterile compounding standards

Answer

Radiopharmaceutical preparation guidelines

Answer

Controlled substance handling procedures

Question 5

Prometrium (micronized progesterone) is best classified as which type of hormone preparation?

Accepted Answer

An FDA-approved bioidentical hormone product

Answer

A synthetic progestin

Answer

A compounded bioidentical hormone

Answer

A conjugated equine progestin

Question 6

What is a 'beyond-use date' (BUD) as applied to compounded hormone preparations?

Accepted Answer

The date after which the compounded preparation should not be used

Answer

The date the raw ingredients were manufactured

Answer

The date the prescription was written by the prescriber

Answer

The expiration date stamped on the raw ingredient container

Question 7

Which of the three primary endogenous estrogens is the weakest and is often highlighted in BHRT for its potentially favorable safety profile?

Accepted Answer

Estriol (E3)

Answer

Estrone (E1)

Answer

Estradiol (E2)

Answer

Ethinyl estradiol