Free PTCB Federal Requirements practice test

Correct answer: B

Subpart P requires every container of non-creditable hazardous waste pharmaceuticals at a healthcare facility (pharmacies included) to be labeled "Hazardous Waste Pharmaceuticals." The containers must also be structurally sound, kept closed and secured against unauthorized access. Non-creditable means the drug has no reasonable expectation of manufacturer credit (for example, residues, contaminated PPE or spill clean-up).

• A Biohazard labeling belongs to infectious medical waste, not to the hazardous waste pharmaceutical containers that subpart P covers.
• B Correct: 40 CFR 266.502(e) requires each container of non-creditable hazardous waste pharmaceuticals to be labeled or clearly marked with this exact phrase.
• C Controlled substance destruction follows DEA rules; this phrase is not the EPA label required for hazardous waste pharmaceutical containers.
• D Non-creditable waste has no reasonable expectation of manufacturer credit, so it is not return-to-supplier stock and this is not the required label.

Learn this topic: Pharmaceutical waste: P-listed drugs, the sewer ban and safe disposal 5-minute lesson

Source: eCFR: 40 CFR 266.502 Standards for healthcare facilities managing non-creditable hazardous waste pharmaceuticals · eCFR: 40 CFR 266.500 Definitions for this subpart · Report a problem with this question

Correct answer: D

EPA's subpart P bans sewering (flushing or pouring down a drain) of hazardous waste pharmaceuticals by every healthcare facility and reverse distributor. A pharmacy is a healthcare facility under the subpart P definition, and the ban explicitly includes very small quantity generators. The waste goes into a properly labeled hazardous waste pharmaceutical container instead.

• A 40 CFR 266.505 names very small quantity generators specifically as covered by the sewer prohibition.
• B Dilution does not change anything; discharging a hazardous waste pharmaceutical to the sewer is prohibited outright.
• C The FDA flush list is home-disposal advice for patients; it gives a healthcare facility no permission to sewer hazardous waste pharmaceuticals.
• D Correct: all healthcare facilities, including VSQGs operating under 40 CFR 262.14, are prohibited from discharging hazardous waste pharmaceuticals to a sewer.

Learn this topic: Pharmaceutical waste: P-listed drugs, the sewer ban and safe disposal 5-minute lesson

Source: eCFR: 40 CFR 266.505 Prohibition on sewering hazardous waste pharmaceuticals · eCFR: 40 CFR 266.500 Definitions for this subpart · eCFR: 40 CFR 266.501 Applicability · Report a problem with this question

Correct answer: A

P-listed wastes are commercial chemical products that EPA lists as acute hazardous wastes in 40 CFR 261.33(e). Warfarin above 0.3% is P001 (at 0.3% or less it is U248), and nicotine is P075, except FDA-approved OTC nicotine patches, gums and lozenges. Under subpart P, a stock bottle, vial or unit-dose package that held a P-listed drug is considered empty once the drug has been removed in the usual way.

• A Correct: warfarin and its salts at concentrations greater than 0.3% are listed as P001, an acute hazardous waste, in 40 CFR 261.33.
• B The P075 nicotine listing expressly excludes patches, gums and lozenges that are FDA-approved OTC nicotine replacement therapies.
• C Under 40 CFR 266.507(a), a unit-dose container emptied by normal practice is considered empty and its residues are not regulated as hazardous waste.
• D Amoxicillin is not on the P list, so it is not an acute hazardous waste.

Learn this topic: Pharmaceutical waste: P-listed drugs, the sewer ban and safe disposal 5-minute lesson

Source: eCFR: 40 CFR 261.33 Discarded commercial chemical products (P and U lists) · eCFR: 40 CFR 266.507 Residues of hazardous waste pharmaceuticals in empty containers · Report a problem with this question

Correct answer: C

For Schedule III and IV controlled substances, federal law allows up to 5 refills and no fill or refill more than 6 months after the date the prescription was issued, whichever limit comes first. Schedule II prescriptions cannot be refilled at all. Federal regulations set no refill limit for Schedule V; it may be refilled as authorized by the prescriber (state law may be stricter).

• A Refills are prohibited for Schedule II prescriptions, not for Schedule III or IV.
• B Federal law caps Schedule III and IV prescriptions at 5 refills and 6 months, not 11 refills in a year.
• C Correct: 21 CFR 1306.22(a) allows no more than 5 refills and no filling more than 6 months after the date of issue.
• D The 6-month window starts on the date the prescription was issued, not the first fill, and it is 6 months, not a year.

Learn this topic: Controlled substance prescriptions: schedules, refills, partial fills and transfers 6-minute lesson

Source: eCFR: 21 CFR 1306.22 Refilling of prescriptions · eCFR: 21 CFR 1306.12 Refilling prescriptions; issuance of multiple prescriptions · DEA Pharmacist's Manual (2022 edition) · Report a problem with this question

Correct answer: A

Count 6 months from the date the prescription was issued (not the first fill or a refill date): February 3, 2026 plus 6 months is August 3, 2026. After that date, any unused refills are void and a new prescription is needed. The 5-refill cap applies at the same time, so whichever limit is reached first ends the prescription.

• A Correct: no Schedule IV prescription may be filled or refilled more than 6 months after the date it was issued, and February 3 plus 6 months is August 3, 2026.
• B This applies a 1-year window; the federal limit for Schedules III and IV is 6 months.
• C This counts 90 days from the date issued (February 3 plus 90 days is May 4); there is no 90-day limit on Schedule III or IV refills.
• D This counts 6 months from the first refill; the clock starts on the date the prescription was issued.

Learn this topic: Controlled substance prescriptions: schedules, refills, partial fills and transfers 6-minute lesson

Source: eCFR: 21 CFR 1306.22 Refilling of prescriptions · Report a problem with this question

Correct answer: B

Under 21 CFR 1306.13(b), a Schedule II prescription may be partially filled at the request of the patient or the prescriber, and the remaining portions must be filled within 30 days of the date the prescription was written (72 hours for an emergency oral prescription). The total dispensed can never exceed the quantity prescribed. A partial fill because the pharmacy is short of stock follows the separate 72-hour rule.

• A This applies the 72-hour rule, which is for a pharmacy that cannot supply the full quantity (or an emergency oral prescription), not a patient-requested partial fill.
• B Correct: remaining portions of a patient-requested partial fill must be filled no later than 30 days after the date the prescription was written: October 1 plus 30 days is October 31.
• C This counts 30 days from the first partial fill; the 30 days run from the date the prescription was written.
• D This counts 90 days from the date written, which is the cap on total supply for a set of multiple Schedule II prescriptions, not a partial-fill deadline.

Learn this topic: Controlled substance prescriptions: schedules, refills, partial fills and transfers 6-minute lesson

Source: eCFR: 21 CFR 1306.13 Partial filling of prescriptions · eCFR: 21 CFR 1306.12 Refilling prescriptions; issuance of multiple prescriptions · Report a problem with this question

Correct answer: C

Schedule I and II controlled substances must be ordered on a DEA Form 222 or with a digitally signed electronic order through CSOS. Schedules III-V are ordered like other drugs, and the pharmacy keeps the invoice or packing slip as its receiving record. Keep the three form numbers apart: 222 orders, 106 reports theft or loss, 41 records destruction.

• A DEA Form 106 reports a theft or significant loss of controlled substances.
• B DEA Form 41 records the destruction of controlled substances.
• C Correct: a DEA Form 222 (or its electronic CSOS equivalent) is required for each distribution of a Schedule I or II controlled substance.
• D An invoice is the receiving record for Schedule III-V drugs; it cannot be used to order Schedule II drugs.

Learn this topic: Controlled substances from order to destruction: DEA Forms 222, 106 and 41 6-minute lesson

Source: eCFR: 21 CFR 1305.03 Distributions requiring a Form 222 or a digitally signed electronic order · DEA Diversion Control Division: Controlled Substance Ordering System (CSOS) · DEA Pharmacist's Manual (2022 edition) · Report a problem with this question

Correct answer: A

For a theft or significant loss of controlled substances, a pharmacy must notify its DEA Field Division Office in writing within one business day of discovery and then file a complete, accurate DEA Form 106 (online) within 45 days. The clock starts at discovery, not at the date of the theft. Losses in transit from a supplier are reported by the supplier.

• A Correct: 21 CFR 1301.76(b) requires written notice to the DEA Field Division Office within 1 business day of discovery and a complete DEA Form 106 within 45 days.
• B DEA Form 41 records destruction, not theft, and the deadlines are reversed.
• C Two steps are required: a written notice within 1 business day and a complete Form 106 within 45 days.
• D Thefts and significant losses must be reported when they are discovered, not saved for the inventory.

Learn this topic: Controlled substances from order to destruction: DEA Forms 222, 106 and 41 6-minute lesson

Source: eCFR: 21 CFR 1301.76 Other security controls for practitioners · eCFR: 21 CFR 1301.74 Other security controls for non-practitioners · DEA Diversion Control Division: Theft/Loss Reporting · Report a problem with this question

Correct answer: B

At a collection receptacle, the ultimate user (or another authorized non-registrant) puts the drugs in personally. Under 21 CFR 1317.75(c), the collector must not let the customer hand the drugs to any person, and once deposited they are not counted, sorted or inventoried. Receptacles take Schedule II-V controlled substances (and non-controlled drugs if the collector chooses), never Schedule I or illicit drugs.

• A Collected drugs may not be counted, sorted or inventoried, and staff may not take them from the customer.
• B Correct: only the ultimate user may deposit the drugs; the collector may not let the customer transfer them to anyone, including staff.
• C A patient's dispensed drugs may not enter the pharmacy's own inventory, and staff may not accept them by hand.
• D The pharmacy may not take possession of the customer's drugs, and wholesaler returns are for the pharmacy's own stock.

Learn this topic: Controlled substances from order to destruction: DEA Forms 222, 106 and 41 6-minute lesson

Source: eCFR: 21 CFR 1317.75 Collection receptacles · eCFR: 21 CFR 1317.30 Authorization to collect from non-registrants · Report a problem with this question

Correct answer: D

Both federal limits apply to Schedule III and IV prescriptions: 5 refills and 6 months from the date of issue, whichever comes first. Here only 4 refills were used, but the 6-month limit ended on August 1, 2026, so the last refill is void. Oral refill authorizations and partial fills cannot stretch past 6 months; the prescriber must issue a new prescription.

• A An unused refill does not matter once 6 months have passed since the date of issue (August 1, 2026).
• B Partial fills of Schedule III-V prescriptions also cannot be dispensed more than 6 months after the date of issue.
• C Oral authorization can add refills only within the 5-refill, 6-month limit; it cannot extend the window past 6 months.
• D Correct: the prescription could not be filled after August 1, 2026, so the patient needs a new prescription.

Learn this topic: Controlled substance prescriptions: schedules, refills, partial fills and transfers 6-minute lesson

Source: eCFR: 21 CFR 1306.22 Refilling of prescriptions · eCFR: 21 CFR 1306.23 Partial filling of prescriptions · Report a problem with this question

Correct answer: D

A pharmacy takes a complete controlled substance inventory at least every 2 years (the biennial inventory). For opened containers, Schedule I and II drugs need an exact count, while Schedule III, IV and V drugs may be estimated unless the container holds more than 1,000 tablets or capsules. Inventory records are kept for at least 2 years.

• A An opened Schedule IV container may be estimated unless it holds more than 1,000 tablets or capsules.
• B Opened Schedule III-V containers holding 1,000 units or fewer may be estimated.
• C An opened Schedule IV bottle of this size may be estimated.
• D Correct: opened containers of Schedule I or II drugs always require an exact count.

Learn this topic: Controlled substances from order to destruction: DEA Forms 222, 106 and 41 6-minute lesson

Source: eCFR: 21 CFR 1304.11 Inventory requirements · eCFR: 21 CFR 1304.04 Maintenance of records and inventories · Report a problem with this question

Correct answer: B

Under the Combat Methamphetamine Epidemic Act (21 CFR 1314.20), a regulated seller such as a pharmacy may not sell one purchaser more than 3.6 grams of pseudoephedrine, ephedrine or phenylpropanolamine base in a calendar day, regardless of the number of transactions. Separately, a purchaser may not buy more than 9 grams of base in a 30-day period, and mobile retail vendors and mail-order sellers are held to 7.5 grams per 30 days. All limits are counted in grams of base, not grams of salt or number of boxes.

• A 1.8 grams is half the daily limit; it is not a federal threshold.
• B Correct: a regulated seller may not sell more than 3.6 grams of pseudoephedrine base to one purchaser in a calendar day, however many transactions there are.
• C 7.5 grams is the 30-day limit for mobile retail vendors and mail-order sellers, not the daily limit.
• D 9 grams is the purchaser's 30-day buying limit, not the daily sales limit.

Learn this topic: How federal law restricts pseudoephedrine sales and REMS drugs 5-minute lesson

Source: eCFR 21 CFR Part 1314: Retail Sale of Scheduled Listed Chemical Products · DEA Diversion Control: Training Required to Sell Drug Products Containing Ephedrine, Pseudoephedrine, and Phenylpropanolamine (retail) · Report a problem with this question

Correct answer: C

The 3.6-gram daily limit counts every sale to the same purchaser on that calendar day, not just the current transaction. Subtract what was already sold today from 3.6 grams, divide by the base content per package, and round down, because a partial box cannot be sold.

• A 9 comes from using the 9-gram 30-day limit instead of the 3.6-gram daily limit: (9 - 2.4) / 0.72 = 9.2.
• B 5 ignores the 2.4 grams she already bought today: 3.6 / 0.72 = 5.
• C Correct: 3.6 - 2.4 = 1.2 grams remain; 1.2 / 0.72 = 1.67, so only 1 whole box fits under the limit.
• D 2 rounds 1.67 up; 2 boxes add 1.44 grams and bring her total to 3.84 grams, over the 3.6-gram limit.

Learn this topic: How federal law restricts pseudoephedrine sales and REMS drugs 5-minute lesson

Source: eCFR 21 CFR Part 1314: Retail Sale of Scheduled Listed Chemical Products · DEA Diversion Control: Training Required to Sell Drug Products Containing Ephedrine, Pseudoephedrine, and Phenylpropanolamine (retail) · Report a problem with this question

Correct answer: A

The iPLEDGE REMS requires the pharmacy to get an authorization from the REMS before each isotretinoin fill and forbids dispensing after the date the REMS provides. For a patient who can get pregnant who misses this window, the prescriber must repeat the pregnancy test and report it before a new authorization can be issued. The pharmacy reverses the expired authorization and returns the drug to inventory.

• A Correct: the pharmacy may not dispense after the date the REMS provides; a patient who misses the window needs a repeat pregnancy test through the prescriber.
• B Certification of the prescriber and pharmacy is necessary but does not override the dispensing deadline set by the REMS.
• C The REMS has no partial-fill workaround; dispensing after the REMS date is not allowed at all.
• D Pharmacist counseling cannot replace the missing pregnancy test and a valid REMS authorization.

Learn this topic: How federal law restricts pseudoephedrine sales and REMS drugs 5-minute lesson

Source: REMS@FDA: Isotretinoin iPLEDGE Shared System REMS · FDA: What's in a REMS? · Report a problem with this question

Correct answer: C

FDA assigns every recall a class based on the health hazard. Class I means a reasonable probability of serious adverse health consequences or death; Class II means temporary or medically reversible problems, or a remote chance of serious harm; Class III means harm is not likely. The Roman numeral rises as the danger falls.

• A This describes a Class III recall, the least serious class.
• B This describes a Class II recall.
• C Correct: Class I is the most serious class, with a reasonable probability of serious adverse health consequences or death.
• D This describes a market withdrawal, which is not a recall.

Learn this topic: How FDA drug recalls work and what the pharmacy does 4-minute lesson

Source: FDA: Recalls Background and Definitions · eCFR 21 CFR Part 7, Subpart C: Recalls (Including Product Corrections) · Report a problem with this question

Correct answer: D

Recall class follows the degree of hazard: Class I (serious harm or death is reasonably probable), Class II (temporary or reversible harm possible, serious harm remote) and Class III (harm not likely). FDA gives minor labeling errors, defective packaging and incorrect expiration dates as examples of Class III drug recalls. Class III recalls are generally carried out at the wholesale level.

• A Labeling errors can lead to recalls; FDA lists minor labeling errors as an example of a Class III recall.
• B Class I requires a reasonable probability of serious harm or death, which this error does not carry.
• C Class II involves possible temporary or medically reversible harm; this error is not likely to cause harm at all.
• D Correct: a recall in which use of the product is not likely to cause adverse health consequences is Class III.

Learn this topic: How FDA drug recalls work and what the pharmacy does 4-minute lesson

Source: FDA: Understanding Drug Recalls: What to Know and What to Do · FDA: Recalls Background and Definitions · Report a problem with this question

Correct answer: A

Under 21 CFR 7.49, a recall communication identifies the product, lot numbers and codes and gives instructions, and each consignee should carry out those instructions immediately. In the pharmacy that means matching lot numbers, removing the recalled lot from dispensing stock, keeping it separate and labeled, and returning it as the letter directs. Any patient-level action follows the recall's stated depth and the pharmacist's direction.

• A Correct: a recall notice identifies lots so pharmacies can find the affected stock, stop dispensing it and set it aside for return as instructed.
• B Only the listed lot is recalled; pulling every lot is unnecessary and can cause a needless shortage.
• C Contacting patients is done only if the recall strategy calls for it, and telling a patient to stop a medicine is clinical advice for the pharmacist or prescriber.
• D A consignee should carry out the recall instructions immediately; waiting for the Enforcement Report delays removal.

Learn this topic: How FDA drug recalls work and what the pharmacy does 4-minute lesson

Source: eCFR 21 CFR Part 7, Subpart C: Recalls (Including Product Corrections) · FDA: Understanding Drug Recalls: What to Know and What to Do · Report a problem with this question

Correct answer: A

The DSCSA product identifier is a standardized graphic printed in both human-readable form and on a machine-readable data carrier (a barcode). It contains the standardized numerical identifier, which is the NDC plus a unique serial number, along with the lot number and expiration date. It lets each package be identified and verified as it moves through the supply chain.

• A Correct: the product identifier carries the standardized numerical identifier (NDC plus serial number), the lot number and the expiration date.
• B Patient and prescriber details belong on the prescription label, not on the manufacturer's package.
• C Seller names and invoice details are part of transaction records, not the product identifier.
• D A DEA number and storage conditions are not part of the DSCSA product identifier.

Learn this topic: How the DSCSA tracks prescription drugs and what the pharmacy must do 5-minute lesson

Source: 21 U.S.C. 360eee (LII): DSCSA definitions · FDA: Drug Supply Chain Security Act (DSCSA) · Report a problem with this question

Correct answer: C

A suspect product is one the pharmacy has reason to believe may be counterfeit, diverted, stolen, intentionally adulterated or otherwise unfit for distribution. Under the DSCSA, the dispenser must quarantine it, in a clearly identified separate area or by other procedures that keep it from being dispensed, and promptly investigate with its trading partners. If it is cleared it may be dispensed; if it is illegitimate, notification steps follow.

• A Shelving it lets a possibly counterfeit or adulterated drug reach a patient; suspect product must be kept away from saleable stock.
• B Sending it back with no record skips the required quarantine and investigation.
• C Correct: suspect product is quarantined from product intended for dispensing and promptly investigated, with the pharmacist leading the investigation.
• D Destroying it removes the evidence needed to investigate and may be wrong if the product turns out to be legitimate.

Learn this topic: How the DSCSA tracks prescription drugs and what the pharmacy must do 5-minute lesson

Source: 21 U.S.C. 360eee-1 (LII): DSCSA pharmaceutical distribution supply chain requirements · 21 U.S.C. 360eee (LII): DSCSA definitions · FDA: Pharmacists: Utilize DSCSA Requirements to Protect Your Patients · Report a problem with this question

Correct answer: A

Once a dispenser determines, in coordination with the manufacturer, that a product is illegitimate, it must notify FDA and the immediate trading partners that may have received it no later than 24 hours later. FDA's preferred route is the Form FDA 3911 platform in CDER NextGen. The pharmacy then dispositions the product, keeps a sample if requested, and keeps the records for at least 6 years.

• A Correct: within 24 hours of determining that a product is illegitimate, the dispenser must notify FDA and all immediate trading partners it believes may have received it.
• B DEA theft and loss reporting applies to controlled substances; DSCSA illegitimate-product notices go to FDA.
• C Returning it for credit puts illegitimate product back into the supply chain instead of removing it.
• D The dispenser must disposition the product but retain a sample for testing if the manufacturer or FDA requests it.

Learn this topic: How the DSCSA tracks prescription drugs and what the pharmacy must do 5-minute lesson

Source: FDA: Notify FDA of Illegitimate Products · 21 U.S.C. 360eee-1 (LII): DSCSA pharmaceutical distribution supply chain requirements · Report a problem with this question

Correct answer: A

21 CFR 1314.30(a) requires a written or electronic logbook for pseudoephedrine sales, with one exception: an individual buying a single sales package that contains not more than 60 mg of pseudoephedrine. DEA's training adds that this exemption covers pseudoephedrine only, not ephedrine or phenylpropanolamine. The package must still be kept behind the counter or in a locked cabinet.

• A Correct: the logbook rule does not apply to an individual's purchase of a single sales package containing not more than 60 mg of pseudoephedrine.
• B Liquids are scheduled listed chemical products too; their sales must be logged.
• C 3.6 grams is the daily sales limit; sales below it still need a logbook entry.
• D Every sale needs its own logbook entry with the date and time; an earlier signature does not cover it.

Learn this topic: How federal law restricts pseudoephedrine sales and REMS drugs 5-minute lesson

Source: eCFR 21 CFR Part 1314: Retail Sale of Scheduled Listed Chemical Products · DEA Diversion Control: Training Required to Sell Drug Products Containing Ephedrine, Pseudoephedrine, and Phenylpropanolamine (retail) · FDA: Legal Requirements for the Sale and Purchase of Drug Products Containing Pseudoephedrine, Ephedrine, and Phenylpropanolamine · Report a problem with this question

Correct answer: B

FDA separates recalls (violations it would take legal action on, classified I, II or III) from market withdrawals (minor or no violations) and stock recoveries (product still under the firm's control). FDA's own example of a market withdrawal is a product removed because of tampering, without evidence of manufacturing or distribution problems.

• A A recall involves a violation FDA would take legal action against; FDA gives tampering without manufacturing problems as an example of a market withdrawal instead.
• B Correct: a market withdrawal is a removal or correction for a minor violation, or no violation, that FDA would not take legal action on.
• C A stock recovery covers product that never left the firm's direct control; this product was already on the market.
• D A safety alert concerns a medical device that may present an unreasonable risk of substantial harm, not a drug removed for tampering.

Learn this topic: How FDA drug recalls work and what the pharmacy does 4-minute lesson

Source: FDA: Recalls Background and Definitions · eCFR 21 CFR Part 7, Subpart C: Recalls (Including Product Corrections) · Report a problem with this question