Free PTCB Practice Test · Topic Drill
Federal Pharmacy Law Practice Test
30 PTCE-style questions, one at a time — just like exam day. Score and full explanations at the end. Free, no signup.
Federal law questions reward precision: which schedule, which DEA form, which recall class, how many grams of pseudoephedrine. These 30 questions cover the Controlled Substances Act, DEA forms and registration, prescription and refill rules, HIPAA, and FDA recalls — the exact territory the PTCE draws its Federal Requirements domain from. Every explanation spells out the rule and the trap the distractors set.
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Question 1 of 30.Under the Controlled Substances Act, which drug is classified in Schedule I?
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Under the Controlled Substances Act, which drug is classified in Schedule I?
- Cocaine
- Methadone
- Methamphetamine
- Heroin (correct answer)
Schedule I drugs, such as heroin and LSD, have a high abuse potential and no currently accepted medical use in the United States, so they cannot be prescribed. Cocaine is a tempting choice, but it is Schedule II because it has an accepted medical use as a topical anesthetic; methadone and methamphetamine also have accepted medical uses and are Schedule II.
Which of the following medications is a Schedule II controlled substance?
- Hydromorphone (Dilaudid) (correct answer)
- Diazepam (Valium)
- Testosterone
- Guaifenesin with codeine cough syrup
Hydromorphone is a potent opioid with a high potential for abuse and an accepted medical use, placing it in Schedule II. Testosterone is a plausible distractor because it is controlled, but anabolic steroids are Schedule III; diazepam is Schedule IV, and combination cough preparations that pair a low dose of codeine with a non-narcotic ingredient such as guaifenesin are Schedule V.
Acetaminophen with codeine (Tylenol with Codeine No. 3) is assigned to which federal controlled substance schedule?
- Schedule II
- Schedule III (correct answer)
- Schedule IV
- Schedule V
Codeine combined with a noncontrolled analgesic such as acetaminophen in tablet form is Schedule III, along with drugs like buprenorphine, ketamine, and anabolic steroids. Schedule II is the tempting answer because single-entity codeine is Schedule II, but combining limited amounts of codeine with acetaminophen lowers the abuse potential and the schedule. Only liquid cough preparations that combine dilute codeine with a non-narcotic ingredient reach Schedule V.
Which of the following medications is a Schedule IV controlled substance?
- Methylphenidate (Ritalin)
- Guaifenesin with codeine 10 mg/5 mL cough syrup
- Alprazolam (Xanax) (correct answer)
- Ketamine
Alprazolam, like other benzodiazepines, tramadol, zolpidem, and carisoprodol, is Schedule IV, reflecting a lower abuse potential than Schedules II and III. Methylphenidate is a stimulant in Schedule II, ketamine is Schedule III, and cough syrups that combine guaifenesin with dilute codeine are Schedule V, so each distractor sits in a different schedule.
Which medication is classified federally as a Schedule V controlled substance?
- Pregabalin (Lyrica) (correct answer)
- Oxycodone (OxyContin)
- Tramadol (Ultram)
- Acetaminophen with codeine (Tylenol No. 3)
Pregabalin is Schedule V, the category with the lowest abuse potential, which also includes diphenoxylate/atropine (Lomotil) and cough syrups that combine a non-narcotic ingredient such as guaifenesin with no more than 200 mg of codeine per 100 mL. Tramadol is a common distractor because it feels like a low-risk analgesic, but it is Schedule IV; oxycodone is Schedule II and acetaminophen with codeine is Schedule III.
A pharmacy must use which DEA form to order Schedule II controlled substances from a wholesaler?
- DEA Form 224
- DEA Form 106
- DEA Form 41
- DEA Form 222 (correct answer)
DEA Form 222 (or its electronic equivalent through the CSOS system) is required to order Schedule I and II substances, and it must be signed by a registrant or a person granted power of attorney. Form 224 is tempting because it also involves the DEA, but it is the application to register a pharmacy, not an ordering document; Schedules III-V may be ordered with an ordinary invoice.
Under federal law, who may sign a DEA Form 222 to order Schedule II controlled substances?
- Any licensed pharmacist on duty at the pharmacy
- The DEA registrant, or a person the registrant has granted power of attorney to sign on their behalf (correct answer)
- Any pharmacy employee with the pharmacist-in-charge's verbal approval
- Only a DEA field agent
Only the person who signed the pharmacy's DEA registration application (the registrant) may sign Form 222, unless the registrant executes a power of attorney authorizing another individual — commonly the pharmacist-in-charge — to sign. Being a licensed pharmacist alone does not confer signing authority, and verbal approval is never sufficient.
A pharmacy discovers that a bottle of oxycodone tablets was stolen from the vault. Which DEA form must be filed to report the theft?
- DEA Form 106 (correct answer)
- DEA Form 41
- DEA Form 222
- DEA Form 224
DEA Form 106 is used to report the theft or significant loss of controlled substances, and the pharmacy must also notify its local DEA field office upon discovery. Form 41 is the tempting distractor because it also removes drugs from inventory, but it documents the surrender or destruction of controlled substances, not losses due to theft.
Which DEA form documents the destruction of expired controlled substances that a pharmacy surrenders for disposal?
- DEA Form 222
- DEA Form 106
- DEA Form 41 (correct answer)
- DEA Form 224
DEA Form 41 is the record of controlled substances surrendered for destruction, such as expired stock sent to a reverse distributor. Form 106 is defensibly wrong because it covers theft or significant loss, not planned destruction; Form 222 is for ordering Schedule I-II drugs and Form 224 is the pharmacy's registration application.
Under federal law, a prescription for a Schedule III controlled substance may be refilled how many times?
- No refills are permitted
- Up to 5 refills within 12 months of the issue date
- An unlimited number of refills within 6 months
- Up to 5 refills within 6 months of the issue date (correct answer)
Schedule III and IV prescriptions may be refilled a maximum of 5 times within 6 months of the date the prescription was issued, whichever limit is reached first. The 12-month option is tempting because it matches the federal standard for many noncontrolled prescriptions, but controlled substances in Schedules III-V expire after 6 months.
A patient asks for a refill of a Schedule II oxycodone prescription. Under federal law, what should the technician tell the patient?
- Schedule II prescriptions cannot be refilled; a new prescription is required (correct answer)
- One refill is allowed if it is used within 30 days
- Up to 5 refills are allowed within 6 months
- A refill is allowed if the prescriber gives verbal approval by phone
Federal law prohibits refills on Schedule II prescriptions, so the prescriber must issue a new prescription for each fill. Verbal approval is a tempting distractor because it works for refill authorizations on noncontrolled drugs and Schedules III-V, but a phoned refill authorization can never convert into a Schedule II fill; the 5-refill rule applies only to Schedules III and IV.
Under federal law, how many times may a Schedule IV prescription with remaining refills be transferred between pharmacies that do not share a real-time electronic database?
- As many times as refills remain
- One time only (correct answer)
- Twice
- It may not be transferred at all
Prescriptions for Schedule III-V substances may be transferred only one time under federal law. 'As many times as refills remain' is tempting because pharmacies that share a real-time, online database may transfer up to the maximum refills permitted, but the question specifies pharmacies without a shared database, so the one-transfer limit applies.
A prescriber phones in an emergency oral prescription for a Schedule II medication. Within what time frame must the prescriber deliver a signed written prescription to the pharmacy?
- 72 hours
- 7 days (correct answer)
- 14 days
- 30 days
After an emergency oral Schedule II prescription, the prescriber must furnish a signed written (or valid electronic) prescription within 7 days, and the pharmacist must notify the DEA if it is not received. The 72-hour option is a common trap because 72 hours is the limit for completing a partial fill when stock is insufficient, not the deadline for the written follow-up prescription. The oral order itself is limited to the quantity needed for the emergency period.
A pharmacy has only 40 tablets in stock for a Schedule II prescription written for 60 tablets and dispenses a partial fill. Under federal law, within what time frame must the remaining quantity be supplied?
- 24 hours
- 48 hours
- 72 hours (correct answer)
- 7 days
When a pharmacy cannot supply the full quantity of a Schedule II prescription, it may partially fill it and must dispense the balance within 72 hours; otherwise, no further quantity may be supplied and the pharmacist must notify the prescriber. Seven days is a tempting distractor because it is the deadline for the written prescription that follows an emergency oral order, which is a different rule.
Under the Ryan Haight Online Pharmacy Consumer Protection Act, what is generally required before a practitioner may prescribe a controlled substance to a patient over the internet?
- Written consent from the patient's insurance plan
- A prescription quantity limited to a 7-day supply
- Registration of the online pharmacy with the FDA
- At least one in-person medical evaluation of the patient (correct answer)
The Ryan Haight Act requires that a prescriber conduct at least one in-person medical evaluation before issuing a controlled substance prescription by means of the internet, subject to defined telemedicine exceptions. The 7-day supply option is plausible because the Act targets overprescribing by rogue online pharmacies, but the law controls the prescriber-patient relationship rather than setting a federal quantity cap. The registration option is also tempting because the Act does create a special registration for online pharmacies, but that registration is with the DEA, not the FDA.
Under the Prescription Drug Marketing Act (PDMA), which statement about manufacturer drug samples is correct?
- Samples may be sold to patients at a discounted price
- Samples may be dispensed by community pharmacies with a prescription
- Samples may be traded between pharmacies to cover shortages
- Community pharmacies may not receive or dispense manufacturer drug samples (correct answer)
The PDMA prohibits the sale, purchase, or trade of prescription drug samples and bars retail pharmacies from receiving them; samples may be distributed only to licensed prescribers (or hospital pharmacies at a prescriber's written request). Dispensing samples with a prescription sounds reasonable, but community pharmacies are excluded entirely because the law was written to keep diverted and mishandled samples out of the retail supply chain.
The Omnibus Budget Reconciliation Act of 1990 (OBRA-90) requires pharmacies to do which of the following for Medicaid patients?
- Offer medication counseling on new prescriptions (correct answer)
- Provide all prescriptions in child-resistant containers without exception
- Waive copayments for generic drugs
- Report all dispensing data to the DEA
OBRA-90 requires that Medicaid patients be offered counseling by a pharmacist and that a prospective drug utilization review be performed; most states have extended these requirements to all patients. Child-resistant packaging is a tempting distractor, but that requirement comes from the Poison Prevention Packaging Act of 1970 and allows exceptions when the patient or prescriber requests non-safety caps.
A Medicaid patient accepts the offer of counseling on a new prescription, as required by OBRA-90. Who must provide the counseling?
- The pharmacy technician who entered the prescription
- Any trained pharmacy staff member
- The pharmacist (correct answer)
- The prescriber's office by telephone
Counseling is a professional judgment activity that only the pharmacist may perform; it includes discussing the drug name, directions, side effects, and storage. The technician option is tempting because technicians may make the offer to counsel and refer the patient, but they may not conduct the counseling itself, which is outside the technician's scope of practice.
Under HIPAA, which of the following disclosures of protected health information is permitted without the patient's written authorization?
- Faxing a patient's medication profile to the physician who is treating that patient (correct answer)
- Discussing a patient's HIV medication with the patient's employer
- Selling a list of patients' prescriptions to a marketing company
- Telling a patient's neighbor which antibiotics the patient picks up
HIPAA permits the use and disclosure of protected health information without authorization for treatment, payment, and health care operations (TPO), and sending a profile to the treating physician is a treatment purpose. Disclosure to an employer might seem work-related, but employers are not treatment providers, so it requires the patient's written authorization, as do marketing sales and casual disclosures to third parties.
A technician needs to verify a patient's insurance eligibility. Which HIPAA principle requires the technician to access only the information needed for that task?
- The privacy notice requirement
- The minimum necessary standard (correct answer)
- The business associate rule
- The breach notification rule
The minimum necessary standard requires covered entities to limit access, use, and disclosure of protected health information to the least amount needed to accomplish the task, so an eligibility check should not involve browsing the full medication history. The privacy notice requirement is a plausible distractor, but it only obligates the pharmacy to inform patients of its privacy practices; it does not limit how much data a worker may access.
The FDA classifies a drug recall as Class I when which of the following is true?
- Use of the product is not likely to cause any adverse health consequences to patients who receive it
- Use of the product may cause temporary or medically reversible adverse health consequences to patients
- The manufacturer is removing the product from the market to correct a minor labeling or packaging defect
- There is a reasonable probability that use of the product will cause serious adverse health consequences or death (correct answer)
Class I is the most serious recall classification, reserved for situations where use of or exposure to the product carries a reasonable probability of serious harm or death, such as a sterile injectable contaminated with bacteria. The 'temporary or reversible harm' option describes Class II, and the remaining options describe Class III situations, which is why recall class questions hinge on the severity of the expected harm.
A tablet lot is recalled because some tablets are slightly subpotent, and use may cause temporary, medically reversible effects. How would the FDA classify this recall?
- Class I
- Class II (correct answer)
- Class III
- Market withdrawal
A Class II recall applies when the product may cause temporary or medically reversible adverse health consequences, or when the probability of serious harm is remote, which fits a modestly subpotent tablet. Class III is the tempting choice, but it is reserved for defects unlikely to cause any adverse health effect; a market withdrawal is a voluntary firm action for minor issues that would not warrant FDA legal action.
A manufacturer recalls a bottle lot because the label has a minor printing defect that is not likely to cause any adverse health consequences. This is an example of which recall classification?
- Class I recall
- Class II recall
- Class III recall (correct answer)
- Market withdrawal
Class III recalls involve products that violate FDA regulations but are unlikely to cause harm, such as minor labeling or packaging defects. Class II is a tempting distractor because both are non-life-threatening categories, but Class II requires at least the possibility of temporary or reversible harm, while Class III products are not expected to cause any adverse health consequences. A market withdrawal is also tempting, but it applies when the issue involves no violation or only a minor one that would not be subject to FDA legal action, such as routine stock recovery; a violative label still calls for a Class III recall.
What is the primary purpose of a Risk Evaluation and Mitigation Strategy (REMS) required by the FDA?
- To ensure that a drug's benefits outweigh its serious safety risks (correct answer)
- To speed up FDA approval for generic drugs
- To set the wholesale acquisition cost of high-risk drugs
- To track pharmacy inventory of controlled substances
A REMS is a drug safety program the FDA can require for medications with serious safety concerns, ensuring the benefits of use outweigh the risks through tools such as medication guides, prescriber training, and restricted distribution. Tracking controlled substance inventory is a tempting distractor because both involve oversight of higher-risk drugs, but inventory control belongs to the DEA under the Controlled Substances Act, not to FDA REMS programs.
Some REMS programs include Elements to Assure Safe Use (ETASU). Which of the following is an example of an ETASU?
- Requiring the pharmacy to stock the drug in a locked cabinet
- Requiring a childproof cap on every bottle dispensed
- Requiring a coupon program to reduce the patient's copay
- Requiring prescribers to be specially certified before prescribing the drug (correct answer)
ETASU are the most restrictive REMS elements and can include prescriber certification, pharmacy certification, dispensing only in certain settings, patient registries, and required laboratory monitoring, as seen in the iPLEDGE program for isotretinoin. Locked storage is a plausible distractor because it sounds like a safety control, but physical security requirements come from DEA controlled substance rules, and childproof caps come from the Poison Prevention Packaging Act.
Under the iPLEDGE REMS program, a patient who can become pregnant must use how many forms of contraception while taking isotretinoin (unless committing to continuous abstinence)?
- One
- Two (correct answer)
- Three
- Contraception is recommended but not required
iPLEDGE requires patients who can become pregnant to use two forms of contraception simultaneously—typically one primary and one secondary method—beginning 1 month before, during, and for 1 month after isotretinoin therapy, because the drug is a potent teratogen. One form is the tempting answer since it is standard advice for many drugs with pregnancy warnings, but isotretinoin's severe birth-defect risk drives the stricter two-method requirement, along with monthly pregnancy testing.
Under the iPLEDGE program, what is the maximum quantity of isotretinoin that may be dispensed per prescription?
- A 30-day supply with no refills (correct answer)
- A 14-day supply with one refill
- A 90-day supply with no refills
- A 30-day supply with up to two refills
iPLEDGE limits each isotretinoin prescription to a 30-day supply with no refills, which forces monthly prescriber contact and, for patients who can become pregnant, monthly pregnancy testing before the next fill. The refill options are tempting because isotretinoin is not a controlled substance, but the REMS program—not the Controlled Substances Act—prohibits refills to keep the monthly monitoring cycle intact.
Under the Combat Methamphetamine Epidemic Act (CMEA), what is the maximum amount of pseudoephedrine base a customer may purchase in a single day?
- 1.44 g
- 3.6 g (correct answer)
- 7.5 g
- 9 g
The CMEA limits retail sales of pseudoephedrine to 3.6 g of base per purchaser per day. The 9 g figure is the tempting distractor because it is also a CMEA limit, but it applies to the 30-day purchase total rather than a single day; 7.5 g is the 30-day limit for mail-order sales.
Under the CMEA, what is the maximum amount of pseudoephedrine base a customer may purchase in a 30-day period from retail stores?
- 3.6 g
- 7.5 g
- 9 g (correct answer)
- 24 g
Retail purchases of pseudoephedrine are capped at 9 g of base per customer per 30 days, and the seller must keep products behind the counter, check photo identification, and maintain a logbook of sales for at least 2 years. The 3.6 g option is the daily limit, not the monthly limit, and 7.5 g applies only to mail-order sales—mixing up these three numbers is the most common CMEA error.
A technician is verifying a DEA number for Dr. Warren that begins BW482601 followed by one final digit. Using the DEA checksum method, what should the final digit be?
- 4
- 5
- 6 (correct answer)
- 7
Add the 1st, 3rd, and 5th digits: 4 + 2 + 0 = 6. Add the 2nd, 4th, and 6th digits: 8 + 6 + 1 = 15, then multiply by 2 to get 30. The sum 6 + 30 = 36, and the last digit of 36 is 6, so the valid number is BW4826016. The letters also check out: the first letter reflects the registrant type and the second letter (W) matches the prescriber's last name.
FAQ: Federal Pharmacy Law on the PTCE
What federal law does the PTCE actually test?
The Federal Requirements domain (12.5% of scored questions) draws on the Controlled Substances Act and DEA regulations: drug schedules I through V, prescription and refill rules (no refills on Schedule II; up to five refills within six months for Schedules III and IV), DEA form numbers, pseudoephedrine sales limits (3.6 g per day, 9 g per 30 days), plus HIPAA and FDA recall classes.
Which DEA forms do I need to know?
Four come up constantly: Form 222 to order Schedule I and II drugs, Form 224 to register a pharmacy to dispense controlled substances, Form 106 to report theft or significant loss, and Form 41 to document destruction of controlled substances. This drill groups them into back-to-back questions so the numbers stop blurring together.
Does the PTCE test my state’s pharmacy laws?
No — the exam tests federal requirements only. Where federal and state law differ, the stricter rule wins in practice, and your state’s rules for technicians (registration, licensure, training) are set by your state board of pharmacy. Our state requirements pages spell out what applies where you work.
Are these questions taken from the real PTCE?
No. Real PTCE items are confidential and belong to PTCB — be wary of any site claiming to have them. Our questions are original, written to mirror the style, difficulty, and published content outline of the exam. Scoring well here is strong evidence you are ready, not a preview of the exact questions you will see.
Is this practice test really free?
Yes. Every question, explanation, and score report on PharmacyTechTest is free, with no signup, no credit card, and no trial that expires. Retake any test as many times as you want.
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