All 10 Questions With Complete Rationales
Prefer to read straight through, or want to review after taking the quiz? Every question, the correct answer, and the reasoning behind it are laid out below.
Question 1
Under the Drug Quality and Security Act (DQSA), a Section 503A pharmacy may compound medications WITHOUT a patient-specific prescription under which circumstance?
A. Never — 503A requires a valid patient-specific prescription for all compounding B. For up to a 30-day supply of commonly compounded preparations C. For anticipatory compounding of reasonable quantities based on historical prescribing patterns D. When the preparation is on the FDA shortage list
✅ Answer: C — For anticipatory compounding of reasonable quantities based on historical prescribing patterns
Anticipatory compounding is permitted in limited quantities. 503A pharmacies may compound in anticipation of prescriptions in reasonable quantities based on the historical prescribing patterns of the prescribers they serve. This does NOT apply to large-scale production — that crosses into 503B outsourcing facility territory. 503B facilities do NOT require patient-specific prescriptions.
Question 2
A pharmacist is compounding a water-containing oral solution. According to USP Chapter 795, what is the maximum beyond-use date (BUD) when stored at controlled room temperature?
A. 14 days B. 30 days C. 6 months D. 1 year
✅ Answer: A — 14 days
14 days at room temperature for aqueous oral preparations. USP 795 BUDs for nonsterile preparations: water-containing oral formulations = 14 days (refrigerated); nonaqueous formulations = 6 months; water-containing topical/dermal = 30 days; solid oral dosage forms = 6 months. If refrigerated for aqueous oral, BUD is still 14 days.
Question 3
Which of the following is a primary distinction between a 503B outsourcing facility and a traditional 503A compounding pharmacy?
A. 503B facilities must be located in a hospital setting B. 503B facilities are registered with the FDA and may distribute without patient-specific prescriptions C. 503A pharmacies must comply with cGMP standards D. 503B facilities are exempt from state board of pharmacy oversight
✅ Answer: B — 503B facilities are registered with the FDA and may distribute without patient-specific prescriptions
503B facilities are FDA-registered and can distribute without patient-specific Rxs. Key 503B requirements: voluntary FDA registration, compliance with cGMP (current Good Manufacturing Practices), may sell to hospitals/clinics without individual patient prescriptions, subject to FDA inspection. 503A pharmacies remain primarily under state board oversight and must have a valid Rx (or anticipatory compounding within limits).
Question 4
Under the revised USP 797 (2023), which category applies to a CSP prepared in a facility with ISO 5 conditions but WITHOUT performing sterility testing, intended for use within 12 hours at room temperature?
A. Category 1 B. Category 2 C. Category 3 D. 503B standard
✅ Answer: A — Category 1
Category 1 CSPs. The 2023 USP 797 revision created two categories: Category 1 — BUD ≤12 hours at room temperature or ≤24 hours refrigerated, no sterility or endotoxin testing required, simpler environmental monitoring. Category 2 — longer BUDs assigned per assigned sterility risk, requires sterility testing, full environmental monitoring program, and periodic media fills.
Question 5
USP Chapter 800 requires a negative-pressure room with a minimum of 12 air changes per hour (ACPH) for which type of hazardous drug handling?
A. Receiving and unpacking any hazardous drug B. Compounding antineoplastic hazardous drugs C. Administering oral hazardous drugs to patients D. Counting tablets of Category 2 non-reproductive hazardous drugs with closed containers
✅ Answer: B — Compounding antineoplastic hazardous drugs
Negative-pressure rooms are required for compounding antineoplastics. USP 800 requirements by activity: Compounding antineoplastic HDs = C-PEC (Class II BSC or CACI) in a negative-pressure room (≥12 ACPH). Non-antineoplastic HDs may be compounded in a C-PEC in a normal or positive pressure area depending on dosage form. Receiving/unpacking requires a negative-pressure area. Counting closed containers of NIOSH Table 2 drugs with no additional manipulation may be done in normal conditions.
Question 6
A pharmacy wants to compound a preparation that is essentially a copy of a commercially available FDA-approved product. Under 503A, this is:
A. Permitted if the prescriber documents a clinical difference B. Always prohibited regardless of clinical rationale C. Permitted in any quantity for patient populations D. Only permitted for pediatric patients
✅ Answer: A — Permitted if the prescriber documents a clinical difference
Permitted only with documented clinical difference. 503A prohibits compounding copies of commercially available products UNLESS the prescriber provides documentation of a clinical difference — such as allergy to an excipient, need for a different concentration, or difficulty swallowing. The FDA has enforcement discretion guidelines on this. Simply preferring a lower price is NOT a sufficient clinical difference.
Question 7
Which entity is responsible for maintaining the Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A?
A. DEA B. State Board of Pharmacy C. FDA D. NABP
✅ Answer: C — FDA
FDA. The FDA maintains the 503A bulk drug substance list — drugs that may be used in compounding even if not components of an FDA-approved drug. The FDA publishes a Category 1 list (substances nominated for inclusion) and a Category 2 list (substances that may not be used). The DEA handles controlled substances scheduling. State boards oversee licensure. NABP develops model pharmacy acts.
Question 8
A hospital pharmacist is preparing a sterile preparation for a patient and labels it with a BUD of 9 days at refrigerated temperature. According to USP 797, this preparation must meet which category requirements at minimum?
A. Category 1 standards only B. Category 2 standards including sterility testing C. Either category if ISO 5 environment is maintained D. No category applies — hospital preparations are exempt
✅ Answer: B — Category 2 standards including sterility testing
Category 2 — BUD exceeds Category 1 limits. Category 1 BUDs: ≤12 hours at room temperature, ≤24 hours refrigerated. A 9-day refrigerated BUD far exceeds Category 1. Category 2 applies when longer BUDs are needed and requires: sterility testing, bacterial endotoxin testing, environmental monitoring, personnel training/competency, and gloved fingertip sampling.
Question 9
Which of the following substances appears on the FDA's list of bulk drug substances that may NOT be used in 503A compounding (Category 2 list)?
A. Ketamine B. Hydroxyprogesterone caproate (17-P) C. Vancomycin D. Omeprazole
✅ Answer: B — Hydroxyprogesterone caproate (17-P)
Hydroxyprogesterone caproate (17-P). The FDA placed 17-hydroxyprogesterone caproate on the Category 2 (do not compound) list after the FDA-approved product (Makena) was withdrawn from the market. The FDA's position is that 503A pharmacies may not compound preparations that are essentially copies of withdrawn products when the withdrawal was for safety or efficacy reasons. This was a high-profile DQSA enforcement action.
Question 10
A pharmacist at a 503A pharmacy dispenses a compounded preparation. The label must include which of the following elements NOT required on a manufactured drug label?
A. Name of the prescribing practitioner B. NDC number C. DEA registration number of the pharmacy D. Lot number assigned by the FDA
✅ Answer: A — Name of the prescribing practitioner
Name of the prescribing practitioner is required on compounded Rx labels. Compounded preparation labels under 503A must include: patient name, prescriber name, pharmacy name/address, preparation name, strength, quantity, directions, BUD, storage conditions, and lot number (pharmacy-assigned). Commercial drug labels do NOT include the prescriber name. NDC numbers apply only to FDA-approved manufactured drugs — compounded preparations may not carry NDC numbers.
📌 How to use these
Answer each question before reading the rationale, and treat "right but unsure" as wrong. The rationale matters more than the answer — if you cannot explain why the other three options fail, you have not learned the rule yet. Ready for more? Work through the other free quizzes or the pharmacy law cheat sheet.