16 Federal Law & Compliance Practice Questions & Answers

Every Federal Law & Compliance practice question from the Pharmacy Technician (PTCB) Practice Test, with the correct answer and a short explanation.

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1. Under the Controlled Substances Act, which schedule is reserved for drugs with NO accepted medical use in the United States and a high potential for abuse?
- A.Schedule I✓ Answer
- B.Schedule II
- C.Schedule IV
- D.Schedule V
Schedule I drugs (e.g., heroin, LSD) are defined by having no currently accepted medical use plus a high abuse potential, so they cannot be prescribed or dispensed. Schedule II drugs also have high abuse potential but DO have accepted medical uses.
Source: Controlled Substances Act, 21 U.S.C. 812(b)(1)Report a problem with this question
2. A DEA Form 222 (or its electronic CSOS equivalent) is required for which transaction?
- A.Ordering Schedule IV controlled substances
- B.Reporting a theft of controlled substances
- C.Ordering Schedule II controlled substances✓ Answer
- D.Filling a Schedule III prescription
DEA Form 222 (paper) or the electronic Controlled Substance Ordering System (CSOS) is required specifically to order or transfer Schedule I and II substances, creating a strict chain-of-custody record. Schedules III–V may be ordered with an ordinary invoice.
Source: 21 CFR 1305.03 (order form required for Schedule I and II)Report a problem with this question
3. Which agency is responsible for approving new drugs and regulating drug manufacturing, labeling, and recalls?
- A.CMS (Centers for Medicare & Medicaid Services)
- B.OSHA (Occupational Safety and Health Administration)
- C.DEA (Drug Enforcement Administration)
- D.FDA (Food and Drug Administration)✓ Answer
The FDA regulates the safety, efficacy, approval, labeling, and recall of drugs under the Federal Food, Drug, and Cosmetic Act. The DEA, by contrast, enforces controlled-substance laws and does not approve drugs.
Source: Federal Food, Drug, and Cosmetic Act (FDA authority)Report a problem with this question
4. A drug recall in which serious adverse health consequences or death are likely to result from use is classified as which class?
- A.Class III
- B.Class IV
- C.Class II
- D.Class I✓ Answer
A Class I recall is the most serious level, used when there is a reasonable probability that the product will cause serious adverse health consequences or death. Class II involves temporary or reversible harm, and Class III is unlikely to cause harm.
Source: FDA recall classification, 21 CFR 7.3(m)Report a problem with this question
5. Under the Poison Prevention Packaging Act, what must most prescription drugs dispensed to outpatients be packaged in?
- A.Amber-colored glass only
- B.Unit-dose blister packs
- C.Child-resistant containers✓ Answer
- D.Tamper-evident foil seals only
The Poison Prevention Packaging Act requires most oral prescription drugs to be dispensed in child-resistant packaging to reduce accidental poisonings in children. A patient or prescriber may request non-child-resistant (easy-open) containers.
Source: Poison Prevention Packaging Act of 1970 (15 U.S.C. 1471)Report a problem with this question
6. For a generic drug to be substituted for a brand-name product, the generic must be demonstrated to the FDA as:
- A.Chemically identical in inactive ingredients
- B.Lower in strength than the brand
- C.Manufactured by the same company
- D.Therapeutically equivalent (bioequivalent)✓ Answer
A generic may be substituted only if the FDA rates it therapeutically equivalent (bioequivalent) to the brand, as listed in the Orange Book with an 'A' rating. Inactive ingredients may differ, and generics must have the same strength as the brand.
Source: FDA Orange Book therapeutic equivalence ('A' rated) standardReport a problem with this question
7. Which of these is an example of a Schedule II controlled substance?
- A.Diphenhydramine
- B.Guaifenesin with codeine (cough syrup)
- C.Alprazolam (Xanax)
- D.Oxycodone✓ Answer
Oxycodone is a Schedule II opioid because it has a high potential for abuse with an accepted medical use. Alprazolam is Schedule IV, diphenhydramine is a non-controlled OTC antihistamine, and low-dose codeine cough syrup is Schedule V.
Source: DEA controlled substance schedules, 21 CFR 1308.12 (Schedule II)Report a problem with this question
8. How long must most federal records of controlled-substance receipt and dispensing generally be retained and available for inspection?
- A.At least 10 years
- B.At least 2 years✓ Answer
- C.Indefinitely, forever
- D.At least 6 months
The Controlled Substances Act requires controlled-substance records (invoices, DEA 222 forms, dispensing records, inventories) to be kept for at least 2 years for federal inspection. Some states require longer, in which case the stricter rule applies.
Source: 21 CFR 1304.04 (2-year record retention)Report a problem with this question
9. How often must a pharmacy take a complete inventory of all controlled substances on hand under DEA rules?
- A.Every 5 years
- B.Only when the DEA requests it
- C.Every 2 years (biennial inventory)✓ Answer
- D.Every month
The DEA requires a complete inventory of all controlled substances at least every two years (a biennial inventory), in addition to an initial inventory when a pharmacy first handles controlled substances. This creates an auditable baseline of stock.
Source: 21 CFR 1304.11 (biennial inventory)Report a problem with this question
10. A REMS (Risk Evaluation and Mitigation Strategy) program is required by the FDA primarily to:
- A.Speed up generic drug approval
- B.Ensure a drug's benefits outweigh its serious risks✓ Answer
- C.Lower the cost of expensive medications
- D.Track controlled-substance sales for the DEA
A REMS is an FDA-required safety program for certain high-risk drugs to ensure the benefits outweigh the risks; it may include elements such as medication guides, prescriber certification, or patient enrollment (e.g., isotretinoin's iPLEDGE, clozapine REMS).
Source: FDAAA 2007, Section 505-1 (REMS authority)Report a problem with this question
11. Which schedule generally allows the FEWEST restrictions and may include certain low-dose codeine cough preparations?
- A.Schedule V✓ Answer
- B.Schedule I
- C.Schedule III
- D.Schedule II
Schedule V drugs have the lowest abuse potential among controlled substances and include preparations like low-dose codeine cough syrups and pregabalin. They may in some states be sold with limited restrictions, unlike higher schedules.
Source: 21 U.S.C. 812(b)(5); 21 CFR 1308.15 (Schedule V)Report a problem with this question
12. When a pharmacy discovers a theft or significant loss of controlled substances, which agency must it notify?
- A.The FTC (Federal Trade Commission)
- B.OSHA
- C.The DEA✓ Answer
- D.The FDA
The DEA must be notified of any theft or significant loss of controlled substances, in writing (via DEA Form 106) and often to local police. The DEA enforces the diversion and security requirements of the Controlled Substances Act, not the FDA.
Source: 21 CFR 1301.74(c), 1301.76(b) (theft/loss reporting via DEA Form 106)Report a problem with this question
13. A DEA registration number is assigned to which of the following?
- A.Each individual pharmacy technician
- B.Prescribers and entities authorized to handle controlled substances✓ Answer
- C.The manufacturer of every OTC medication
- D.Every patient receiving a prescription
A DEA number is issued to prescribers, pharmacies, hospitals, and other registrants authorized to prescribe, dispense, or handle controlled substances. Patients and individual pharmacy technicians are not issued DEA numbers. The number can be verified with a checksum formula.
Source: 21 CFR 1301.11 (persons required to register with the DEA)Report a problem with this question
14. A pharmacy discovers that a bottle of a Schedule II controlled substance has been stolen. Which DEA form must be completed to report this theft or significant loss?
- A.DEA Form 222
- B.DEA Form 41
- C.DEA Form 106✓ Answer
- D.DEA Form 224
DEA Form 106 is the report of theft or significant loss of controlled substances; it is submitted to the DEA when a diversion, theft, or major loss occurs. Form 222 is used to order Schedule II drugs, Form 41 documents the destruction of controlled substances, and Form 224 is the pharmacy's registration application, so none of those report a theft.
Source: 21 CFR 1301.76(b); DEA Pharmacist's Manual (report theft/significant loss on DEA Form 106)Report a problem with this question
15. Under the Combat Methamphetamine Epidemic Act (CMEA), what is the maximum amount of pseudoephedrine base a single customer may purchase from a retail pharmacy in one day?
- A.3.6 grams per day✓ Answer
- B.1.2 grams per day
- C.9 grams per day
- D.7.5 grams per day
The CMEA caps a customer's pseudoephedrine purchases at 3.6 grams of base per calendar day, with a separate limit of 9 grams over any 30-day period. The daily limit prevents bulk buying used to divert pseudoephedrine into illicit methamphetamine manufacture, so 9 grams (the 30-day cap) and the other figures are incorrect for a single day.
Source: Combat Methamphetamine Epidemic Act of 2005, 21 USC 830(d) (3.6 g/day, 9 g/30 days)Report a problem with this question
16. Which of the following may be routinely dispensed WITHOUT a child-resistant container, even though no specific request is made by the patient or prescriber?
- A.Sublingual nitroglycerin tablets✓ Answer
- B.Amoxicillin capsules
- C.Lisinopril tablets
- D.Metformin tablets
The Poison Prevention Packaging Act specifically exempts sublingual nitroglycerin from child-resistant packaging so patients can access it quickly during acute angina, making it dispensable in non-child-resistant containers without any request. Amoxicillin, metformin, and lisinopril have no such exemption and require child-resistant packaging unless the patient or prescriber requests otherwise.
Source: Poison Prevention Packaging Act, 16 CFR 1700.14(a)(10) (sublingual nitroglycerin exemption)Report a problem with this question

Practice questions based on the PTCB exam content outline. Not affiliated with the PTCB, and not medical advice. About the PTCE →

1. Under the Controlled Substances Act, which schedule is reserved for drugs with NO accepted medical use in the United States and a high potential for abuse?

2. A DEA Form 222 (or its electronic CSOS equivalent) is required for which transaction?

3. Which agency is responsible for approving new drugs and regulating drug manufacturing, labeling, and recalls?

4. A drug recall in which serious adverse health consequences or death are likely to result from use is classified as which class?

5. Under the Poison Prevention Packaging Act, what must most prescription drugs dispensed to outpatients be packaged in?

6. For a generic drug to be substituted for a brand-name product, the generic must be demonstrated to the FDA as:

7. Which of these is an example of a Schedule II controlled substance?

8. How long must most federal records of controlled-substance receipt and dispensing generally be retained and available for inspection?

9. How often must a pharmacy take a complete inventory of all controlled substances on hand under DEA rules?

10. A REMS (Risk Evaluation and Mitigation Strategy) program is required by the FDA primarily to:

11. Which schedule generally allows the FEWEST restrictions and may include certain low-dose codeine cough preparations?

12. When a pharmacy discovers a theft or significant loss of controlled substances, which agency must it notify?

13. A DEA registration number is assigned to which of the following?

14. A pharmacy discovers that a bottle of a Schedule II controlled substance has been stolen. Which DEA form must be completed to report this theft or significant loss?

15. Under the Combat Methamphetamine Epidemic Act (CMEA), what is the maximum amount of pseudoephedrine base a single customer may purchase from a retail pharmacy in one day?

16. Which of the following may be routinely dispensed WITHOUT a child-resistant container, even though no specific request is made by the patient or prescriber?