PTCB Federal Requirements: Controlled Substances and Pharmacy Law
Updated October 27, 2026
Federal Requirements is 18.75% of the PTCE. Most of it comes down to the controlled substance schedules, the DEA forms pharmacies use, and a handful of other federal laws. Learn the tables below, then try the free questions.
State laws can be stricter than federal law, and the stricter rule applies. The PTCE tests federal law.
Controlled substance schedules
| Schedule | Abuse potential | Examples |
|---|---|---|
| C-I | Highest; no currently accepted medical use | Heroin, LSD |
| C-II | High | Oxycodone, fentanyl, morphine, hydrocodone, methylphenidate, amphetamine salts |
| C-III | Moderate to low | Buprenorphine, anabolic steroids such as testosterone, acetaminophen with codeine |
| C-IV | Low | Alprazolam and other benzodiazepines, tramadol, zolpidem |
| C-V | Lowest | Cough preparations with small amounts of codeine, pregabalin |
Refills
| Schedule | Refills |
|---|---|
| C-II | No refills; a new prescription is needed each time |
| C-III and C-IV | Up to 5 refills within 6 months of the date written |
| C-V | As authorized by the prescriber, subject to state law |
DEA forms
| Form | Used for |
|---|---|
| DEA 222 (or its electronic version, CSOS) | Ordering C-I and C-II substances |
| DEA 224 | Registering a pharmacy to dispense controlled substances |
| DEA 106 | Reporting theft or significant loss of controlled substances |
| DEA 41 | Recording controlled substances destroyed |
Other federal laws that show up often
- Combat Methamphetamine Epidemic Act: limits sales of pseudoephedrine (3.6 g per day and 9 g per 30 days per purchaser), requires the product to be kept behind the counter, and requires a logbook.
- Poison Prevention Packaging Act: requires child-resistant containers for most prescription drugs, unless the patient or prescriber asks for an easy-open cap.
- HIPAA: protects patients’ health information.
- REMS programs: FDA safety programs for certain high-risk drugs, such as iPLEDGE for isotretinoin.
Free PTCB federal law practice questions
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Oxycodone is in which controlled substance schedule?Answer: AOxycodone is a Schedule II opioid, with a high potential for abuse and an accepted medical use.
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Which DEA form is used to order Schedule II controlled substances?Answer: BDEA Form 222, or its electronic version through CSOS, is used to order Schedule I and II substances.
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How many refills are allowed on a prescription for a Schedule III drug under federal law?Answer: CSchedule III and IV prescriptions may be refilled up to 5 times within 6 months of the date written. Schedule II prescriptions can't be refilled.
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A pharmacy discovers a significant loss of controlled substances. Which DEA form is used to report it?Answer: ADEA Form 106 reports theft or significant loss of controlled substances. DEA Form 41 records controlled substances that are destroyed.
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Alprazolam is in which schedule?Answer: DAlprazolam, like other benzodiazepines, is a Schedule IV controlled substance.
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Under the Combat Methamphetamine Epidemic Act, what is the daily limit for pseudoephedrine sales to one purchaser?Answer: BThe federal limit is 3.6 g per day and 9 g in 30 days per purchaser. The product must be kept behind the counter, and sales are recorded in a logbook.
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Under federal law, how often must a pharmacy take a complete inventory of its controlled substances?Answer: CDEA requires a complete controlled substance inventory at least every 2 years. State law may require it more often.
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In the biennial inventory, how must Schedule II controlled substances be counted?Answer: ASchedule II drugs require an exact count. Schedule III to V drugs can usually be estimated, unless a container holds more than 1,000 tablets or capsules, which must be counted exactly.
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Under federal law, a prescription for a Schedule III or IV drug expires:Answer: BSchedule III and IV prescriptions can't be filled or refilled more than 6 months after the date written, and no more than 5 refills are allowed in that time.
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For how long does federal law require pharmacies to keep controlled substance records?Answer: CDEA requires controlled substance records, such as inventories and order forms, to be kept for at least 2 years. Many states require longer.
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Which federal law requires pharmacists to offer counseling to Medicaid patients?Answer: COBRA '90 requires an offer to counsel Medicaid patients and a prospective drug review. Most states now require the offer to counsel for all patients.
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Which FDA publication lists approved drugs and their therapeutic equivalence ratings, used to decide generic substitution?Answer: DThe Orange Book, "Approved Drug Products with Therapeutic Equivalence Evaluations," gives ratings such as "AB" that show which generics are therapeutically equivalent to a brand.
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A prescriber phones in an emergency prescription for a Schedule II drug. Under federal law, what must follow?Answer: AIn a true emergency, a Schedule II drug can be dispensed on an oral order for the emergency period, but the prescriber must deliver a written (or electronic) prescription within 7 days.
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Which federal law created the five schedules for controlled substances?Answer: BThe Controlled Substances Act of 1970 set up the five schedules and DEA's registration and recordkeeping system. The Durham-Humphrey Amendment created the distinction between prescription and over-the-counter drugs.
Pass the PTCB exam on your first try
- All 194 questions across medications, federal requirements, patient safety and order entry
- An explanation for every answer, with the law, standard or label behind it
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