• 166 questions

Pharmacy Law and Regulations Practice Test

Federal rules only: state pharmacy law and the rest of any certification exam are not here.

After its first registration period, a retail pharmacy's DEA registration runs for how long?

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Unofficial practice questions, not affiliated with the DEA, the FDA or any board of pharmacy. Bank checked October 4, 2026.

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All 166 questions

DEA registration and security 20

  • A hospital order to give a drug to a bed patient for immediate administration is what, under DEA's definitions? 21 CFR 1300.01
  • A new pharmacy has filed its application for DEA registration. When may it begin dispensing controlled substances? 21 CFR 1301.13(a)
  • A parent corporation owns a pharmacy company but handles no controlled substances itself. Must the parent register with DEA? 21 CFR 1301.11(a)
  • A pharmacy discovers a theft of controlled substances. How soon must it notify the DEA Field Division Office in writing? 21 CFR 1301.76(b)
  • A pharmacy is selling its business to another registrant. How far ahead must it send the transfer details to the DEA Special Agent in Charge? 21 CFR 1301.52(d)
  • A registered pharmacy that meets the definition of an online pharmacy wants to dispense controlled substances by means of the internet. What must it obtain first? 21 CFR 1301.11(d)
  • A registrant that stops handling controlled substances for good, without selling the business, must return what to DEA? 21 CFR 1301.52(c)
  • A retail pharmacy hires a carrier to fetch filled prescriptions from a central fill pharmacy, and some are lost on the road. Who reports the in-transit loss? 21 CFR 1301.76(d)
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DEA registration and security, continued

  • After discovering a theft or significant loss, a registrant must file a complete DEA Form 106 within how many days? 21 CFR 1301.76(b)
  • After its first registration period, a retail pharmacy's DEA registration runs for how long? 21 CFR 1301.13(d)
  • DEA's definition of an individual practitioner leaves out which of these? 21 CFR 1300.01
  • How early may a registered retail pharmacy apply to be reregistered with DEA? 21 CFR 1301.13(b)
  • In DEA's definitions, the term pharmacist also covers which person? 21 CFR 1300.01
  • Instead of a locked cabinet, how may a pharmacy store Schedule II to V controlled substances? 21 CFR 1301.75(b)
  • One company dispenses controlled substances at two pharmacies in different towns. How many DEA registrations does it need? 21 CFR 1301.12(a)
  • Under DEA's security rules, a pharmacy must not give access to controlled substances to an employee who has what in their past? 21 CFR 1301.76(a)
  • Under DEA's stated position, an employee who knows a coworker is diverting drugs from the employer has an obligation to report it to whom? 21 CFR 1301.91
  • What happens to a DEA registration when the registrant discontinues business? 21 CFR 1301.52(a)
  • When a pharmacy's controlled substances are transferred to a buyer, the inventory taken on the transfer date serves as what? 21 CFR 1301.52(e)
  • Which DEA form reports a theft or significant loss of controlled substances? 21 CFR 1301.76(b)

Order forms for Schedule II 20

  • A DEA Form 222 reaches a supplier with an erasure in the quantity column. What does the rule say? 21 CFR 1305.15(a)
  • A pharmacy fills in a single-sheet DEA Form 222 to buy from a wholesaler. What does it do with the original? 21 CFR 1305.13(a)
  • A pharmacy finds that several unused DEA Forms 222 have been stolen. When must it report the theft to the DEA Special Agent in Charge? 21 CFR 1305.16(b)
  • A purchaser's DEA Form 222 is returned as defective. How is the order placed again? 21 CFR 1305.15(d)
  • A purchaser's DEA registration terminates. What must it do with its unused DEA Forms 222? 21 CFR 1305.18
  • A supplier can ship only part of what a DEA Form 222 orders. By when must the rest be supplied? 21 CFR 1305.13(b)
  • A supplier that fills an electronic order for Schedule II drugs must forward a copy or report of it to DEA within what time? 21 CFR 1305.29
  • How does a purchaser cancel part of an order already sent to a supplier on DEA Form 222? 21 CFR 1305.19(a)
  • How many items may be entered on each numbered line of a DEA Form 222? 21 CFR 1305.12(b)
  • How many witnesses sign a power of attorney that lets another person sign DEA order forms for a registrant? 21 CFR 1305.05
  • How must a pharmacy file its executed DEA Forms 222? 21 CFR 1305.17(c)
  • To be valid, an electronic order for a Schedule II controlled substance must be signed with what? 21 CFR 1305.21(a)
  • The tracking number a purchaser gives an electronic order for Schedule II drugs has how many characters? 21 CFR 1305.21(b)
  • When may a registrant revoke a power of attorney to sign DEA order forms? 21 CFR 1305.05(b)
  • When Schedule II drugs ordered on a DEA Form 222 arrive, what must the purchaser record on its copy of the form? 21 CFR 1305.13(e)
  • Where is a power of attorney to sign DEA order forms kept? 21 CFR 1305.05(a)
  • Where must a supplier ship controlled substances ordered on a DEA Form 222? 21 CFR 1305.13(c)
  • Which document, or its electronic equivalent, is required for each distribution of a Schedule I or II controlled substance? 21 CFR 1305.03
  • Which of these may be used to prepare a DEA Form 222? 21 CFR 1305.12(a)
  • Who may obtain and use DEA Form 222 to order Schedule II drugs? 21 CFR 1305.04(a)

Schedule II prescriptions 24

  • A medical secretary prepares a controlled substance prescription for the practitioner to sign. Who is responsible if it does not meet the rules? 21 CFR 1306.05(f)
  • A patient asks for a Schedule II prescription to be filled in part. The remaining portions must be filled no later than when? 21 CFR 1306.13(b)
  • A patient asks for an unfilled electronic prescription for a controlled substance to be moved to another retail pharmacy for its first fill. How many times may it be transferred? 21 CFR 1306.08(e)
  • A pharmacist cannot supply the full quantity of a Schedule II prescription and fills part of it. Within what time may the rest be filled? 21 CFR 1306.13(a)
  • A pharmacist takes an emergency oral order for a Schedule II drug. What must the pharmacist do with the order? 21 CFR 1306.11(d)
  • A practitioner faxes an ordinary Schedule II prescription to a retail pharmacy. What must the pharmacist have before the drug is actually dispensed? 21 CFR 1306.11(a)
  • A practitioner may issue several Schedule II prescriptions at one visit, to be filled one after another. Together they may supply the patient for up to how long? 21 CFR 1306.12(b)
  • A Schedule II prescription for a Long Term Care Facility patient may be filled in partial quantities for up to how long from its issue date? 21 CFR 1306.13(c)
  • After authorizing an emergency oral Schedule II prescription, the practitioner must get a written prescription to the pharmacist within how many days? 21 CFR 1306.11(d)
  • Before partially filling a Schedule II prescription under the long-term-care and terminal-illness rule, what must the pharmacist record on the prescription? 21 CFR 1306.13(c)
  • During a pharmacy-to-pharmacy transfer of an unfilled electronic controlled substance prescription, what may an intermediary NOT do? 21 CFR 1306.08(f)
  • For which patient may a faxed Schedule II prescription serve as the original written prescription? 21 CFR 1306.11(f)
  • How is a paper prescription for a controlled substance signed? 21 CFR 1306.05(d)
  • How many times may a prescription for a Schedule II controlled substance be refilled? 21 CFR 1306.12(a)
  • In an emergency a pharmacist may dispense a Schedule II drug on a practitioner's oral authorization. How much may be dispensed? 21 CFR 1306.11(d)
  • On what day must a controlled substance prescription be dated and signed? 21 CFR 1306.05(a)
  • The responsibility for proper prescribing rests on the practitioner. Who holds the "corresponding responsibility"? 21 CFR 1306.04(a)
  • The rest of a partly filled Schedule II prescription cannot be supplied within the time the rule allows. What follows? 21 CFR 1306.13(a)
  • The Schedule II label rule does not apply to a drug prescribed for administration to an institutionalized patient when, among other conditions, no more than what supply is dispensed at one time? 21 CFR 1306.14(c)
  • To be effective, a prescription for a controlled substance must be issued for what? 21 CFR 1306.04(a)
  • What words must appear on the face of the written prescription that follows an emergency oral Schedule II order? 21 CFR 1306.11(d)
  • When a practitioner issues multiple Schedule II prescriptions to be filled in sequence, what must each later prescription show? 21 CFR 1306.12(b)
  • Which of these must appear on every prescription for a controlled substance? 21 CFR 1306.05(a)
  • The written prescription covering an emergency oral Schedule II order never arrives. What must the pharmacist do? 21 CFR 1306.11(d)

Schedule III to V prescriptions 17

  • A paper Schedule IV prescription is transferred to another pharmacy for refills. What does the transferring pharmacist write on the face of the invalidated prescription? 21 CFR 1306.25(b)
  • A pharmacist only initials and dates the back of a Schedule III prescription at a refill, with no quantity noted. What quantity is the pharmacist deemed to have dispensed? 21 CFR 1306.22(d)
  • A pharmacist receives a paper-based refill transfer of a Schedule III prescription. What word goes on the face of the transferred prescription? 21 CFR 1306.25(b)
  • A pharmacy keeps Schedule III and IV refill records by computer and prints a daily refill report. Who verifies and signs that printout? 21 CFR 1306.22(f)
  • A pharmacy's computer system prints its daily Schedule III and IV refill report at a central site. Within what time must that printout reach the pharmacy? 21 CFR 1306.22(f)
  • A prescription for a Schedule III controlled substance may not be filled or refilled more than how long after it was issued? 21 CFR 1306.22(a)
  • A refill transfer of a Schedule III to V prescription must be communicated directly between whom? 21 CFR 1306.25(b)
  • A retail pharmacy sends a paper prescription's information to a central fill pharmacy. What does it write on the face of the original? 21 CFR 1306.27
  • May a pharmacist dispense a Schedule IV prescription drug on a practitioner's oral prescription? 21 CFR 1306.21(a)
  • Partial filling of a Schedule III, IV or V prescription is allowed up to what total quantity? 21 CFR 1306.23
  • The Schedule III to V label rule does not apply to a drug prescribed for an institutionalized patient when, among other conditions, the amount dispensed at one time is no more than what? 21 CFR 1306.24(c)
  • The six-month, five-refill limit in the DEA rule is written for prescriptions in which schedules? 21 CFR 1306.22(a)
  • Two pharmacies do not share a database. How many times may one transfer the original prescription information for a Schedule III drug to the other for refills? 21 CFR 1306.25(a)
  • What is the most times a Schedule IV prescription may be refilled? 21 CFR 1306.22(a)
  • Which date goes on the label of a filled Schedule III, IV or V prescription? 21 CFR 1306.24(a)
  • Which pharmacies may transfer a Schedule III to V prescription for refills up to the maximum refills the law and the prescriber allow? 21 CFR 1306.25(a)
  • Who may fill a prescription for a controlled substance? 21 CFR 1306.06

Sales without a prescription 16

  • A chain sells scheduled listed chemical products at six stores. How many self-certifications does it provide? 21 CFR 1314.40(c)
  • A stranger asks to buy a nonprescription Schedule V product. What must the pharmacist require? 21 CFR 1306.26(d)
  • After its initial period, how often must a regulated seller update its self-certification to sell scheduled listed chemical products? 21 CFR 1314.40(b)
  • Federal rules let certain nonprescription controlled substances be dispensed without a prescription. Who must do the dispensing? 21 CFR 1306.26(a)
  • How long must a regulated seller keep each logbook entry for a scheduled listed chemical product sale? 21 CFR 1314.30(e)
  • How much pseudoephedrine base may a mobile retail vendor sell to one purchaser in any 30-day period? 21 CFR 1314.20(b)
  • How much pseudoephedrine base may a regulated seller sell to one purchaser in a single calendar day? 21 CFR 1314.20(a)
  • How must a scheduled listed chemical product reach the purchaser at a retail sale? 21 CFR 1314.25(c)
  • How old must the purchaser of a controlled substance dispensed without a prescription be, under the DEA rule? 21 CFR 1306.26(c)
  • What identification does a purchaser of a scheduled listed chemical product present? 21 CFR 1314.30(b)
  • What record does a pharmacist keep of controlled substances dispensed without a prescription? 21 CFR 1306.26(e)
  • Where must a store keep scheduled listed chemical products, such as those containing pseudoephedrine, before a sale? 21 CFR 1314.25(b)
  • Which purchase of a pseudoephedrine product needs no logbook entry? 21 CFR 1314.30(a)
  • Without a prescription, how many dosage units of a controlled substance containing opium may go to one purchaser in any 48-hour period? 21 CFR 1306.26(b)
  • Without a prescription, what is the most of a liquid controlled substance containing opium that may go to one purchaser in any 48-hour period? 21 CFR 1306.26(b)
  • Without a prescription, what is the most of a liquid controlled substance that does not contain opium that may go to one purchaser in any 48-hour period? 21 CFR 1306.26(b)

Records, inventory and disposal 26

  • A dispenser's record of a controlled substance dispensed includes the name or initials of whom? 21 CFR 1304.22(c)
  • A drug the pharmacy stocks is added to a schedule for the first time. When must the pharmacy inventory its stock of that drug? 21 CFR 1304.11(d)
  • A Long Term Care Facility puts a resident's discontinued controlled substances into its collection receptacle. How soon after the resident stops using them must this happen? 21 CFR 1317.80(a)
  • A patient drops controlled substances into a pharmacy's collection receptacle. What may staff do with them afterwards? 21 CFR 1317.75(c)
  • A pharmacy files paper Schedule III to V prescriptions with its noncontrolled prescriptions. What mark makes them readily retrievable? 21 CFR 1304.04(h)
  • A pharmacy opens with no controlled substances on hand. What does it do about its initial inventory? 21 CFR 1304.11(b)
  • A registrant destroys controlled substances from its stock. On which form is the destruction recorded? 21 CFR 1304.21(e)
  • A registrant is allowed to keep central records. Which records must still stay at each registered location? 21 CFR 1304.04(b)
  • A retail pharmacy wants to collect unused controlled substances from the public. What must it do first? 21 CFR 1317.40(a)
  • After its initial inventory, how often must a pharmacy take a new inventory of all controlled substances on hand? 21 CFR 1304.11(c)
  • At what time of day may a controlled substance inventory be taken? 21 CFR 1304.11(a)
  • Does the DEA records rule require a pharmacy to keep a perpetual inventory of controlled substances? 21 CFR 1304.21(a)
  • During an inventory, an opened bottle of a Schedule IV drug may be estimated unless the container holds more than how many tablets or capsules? 21 CFR 1304.11(e)
  • During an inventory, how does a pharmacy count an opened commercial container of a Schedule II drug? 21 CFR 1304.11(e)
  • For how long must a registrant keep its controlled substance inventories and records available for DEA inspection? 21 CFR 1304.04(a)
  • For how long must the records required for electronic controlled substance prescriptions be kept electronically? 21 CFR 1311.305(b)
  • How many employees of a registrant must handle and witness the on-site destruction of controlled substances? 21 CFR 1317.95(d)
  • How must a pharmacy keep its inventories and records of Schedule II controlled substances? 21 CFR 1304.04(h)
  • To sign an electronic prescription for a controlled substance, the practitioner must authenticate with how many of the three listed factors? 21 CFR 1311.115(a)
  • To what standard must a registrant destroy controlled substances? 21 CFR 1317.90(a)
  • What must be fixed to the cap or covering of each commercial container of a controlled substance? 21 CFR 1302.06
  • What must be printed on the label of each commercial container of a controlled substance? 21 CFR 1302.03(a)
  • When is the red "C" stamp on paper Schedule III to V prescriptions waived? 21 CFR 1304.04(h)
  • Where does a pharmacy file its paper prescriptions for Schedule II drugs? 21 CFR 1304.04(h)
  • Which controlled substances may a pharmacy's collection receptacle take from the public? 21 CFR 1317.75(b)
  • Which is a lawful way for a pharmacy to dispose of controlled substances from its own inventory? 21 CFR 1317.05(a)

FDA labels, recalls and packaging 22

  • A drug has a required Medication Guide. What must the authorized dispenser do when the drug is dispensed? 21 CFR 208.24(e)
  • A drug product has to bear an expiration date. Which parts of its packaging show that date? 21 CFR 201.17
  • A firm pulls back a product that has not been marketed and has never left its direct control. What is this called? 21 CFR 7.3(k)
  • A firm removes a distributed product for a minor violation that FDA would not take legal action over. What is this called? 21 CFR 7.3(j)
  • A manufacturer's package without child-resistant features, offered for people who cannot open special packaging, carries which statement? 16 CFR 1700.5(a)
  • A prescriber directs that a Medication Guide not be given to a patient, but the patient asks for the information. What does the dispenser do? 21 CFR 208.26(b)
  • Before a required Medication Guide may be distributed, who must approve it? 21 CFR 208.24(a)
  • FDA's Medication Guide rule applies to which prescriptions? 21 CFR 208.1(a)
  • The federal "transfer" caution must appear on the label of a dispensed controlled substance in which schedules? 21 CFR 290.5
  • How does FDA's recall policy describe a recall? 21 CFR 7.40(a)
  • In FDA's recall classes, which class means a reasonable probability that the product will cause serious adverse health consequences or death? 21 CFR 7.3(m)
  • In FDA's recall terms, relabeling a product without physically moving it to another location is what? 21 CFR 7.3(h)
  • Special packaging must have a senior adult use effectiveness of not less than what percent? 16 CFR 1700.15(b)
  • Special packaging must show a child-resistant effectiveness of not less than what percent before the children are shown how to open it? 16 CFR 1700.15(b)
  • Under the poison prevention packaging rule, which prescription drugs for human use must be in special packaging? 16 CFR 1700.14(a)
  • What does the caution statement required on a dispensed Schedule II drug label say federal law prohibits? 21 CFR 290.5
  • What is the smallest type size FDA allows for the body of a Medication Guide? 21 CFR 208.20(a)
  • Where does FDA make a descriptive listing of each new recall available to the public? 21 CFR 7.50
  • Which FDA recall class covers a product that may cause temporary or medically reversible adverse health consequences? 21 CFR 7.3(m)
  • Which FDA recall class covers a violative product that is not likely to cause adverse health consequences? 21 CFR 7.3(m)
  • Which statement does the manufacturer's label of a prescription drug for human use bear under FDA's labeling rule? 21 CFR 201.100(b)
  • Who decides that a recall is terminated? 21 CFR 7.55(a)

Counseling offer and privacy 21

  • A breach of unsecured protected health information affects more than 500 residents of one State. Besides the individuals and the Secretary, whom must the covered entity notify? 45 CFR 164.406(a)
  • A Medicaid beneficiary refuses the pharmacist's offer to counsel. Under the federal rule, must the pharmacist still provide the consultation? 42 CFR 456.705(c)
  • A patient asks a covered entity to amend their record. Within how many days of the request must it act? 45 CFR 164.526(b)
  • A patient asks a pharmacy for access to their own records. Within how many days of the request must the pharmacy act? 45 CFR 164.524(b)
  • A patient's right to an accounting of disclosures reaches back how far before the request? 45 CFR 164.528(a)
  • A pharmacy gives a new patient its notice of privacy practices. What must it try to obtain from the patient? 45 CFR 164.520(c)
  • After discovering a breach of unsecured protected health information, a covered entity must notify each affected individual within what time? 45 CFR 164.404(b)
  • Breaches affecting fewer than 500 individuals are logged and reported to the Secretary of Health and Human Services by when? 45 CFR 164.408(c)
  • For how long must a covered entity keep the documentation the privacy rule requires, such as its policies and procedures? 45 CFR 164.530(j)
  • For which purposes may a covered pharmacy use protected health information under section 164.506 of the privacy rule? 45 CFR 164.506(c)
  • How often may a patient get an accounting of disclosures without charge? 45 CFR 164.528(c)
  • To which disclosure does the privacy rule's minimum necessary standard NOT apply? 45 CFR 164.502(b)
  • Under the federal Medicaid drug review rule, when must a review of drug therapy take place? 42 CFR 456.705(a)
  • Under the federal Medicaid rule, who establishes the standards for pharmacists counseling beneficiaries? 42 CFR 456.705(c)
  • Under the federal privacy rule, how much protected health information should a pharmacy disclose for a purpose such as billing? 45 CFR 164.502(b)
  • Under the Medicaid counseling standards, what must a pharmacist do for each beneficiary who presents a prescription? 42 CFR 456.705(c)
  • Under the privacy rule's definition of marketing, a refill reminder for a drug the patient is currently prescribed is not marketing on what condition? 45 CFR 164.501
  • What may a covered entity charge a patient for a copy of their own protected health information? 45 CFR 164.524(c)
  • What must the Medicaid counseling standards say about a beneficiary's refusal of counseling? 42 CFR 456.705(c)
  • What telephone service does the Medicaid counseling rule require of mail order pharmacies? 42 CFR 456.705(c)
  • Whom must a covered entity designate to develop and carry out its privacy policies and procedures? 45 CFR 164.530(a)

How this list was compiled: Every question rests on one section of the Code of Federal Regulations, read on 2026-10-04 at https://www.ecfr.gov and named in the question's own source line. Drug Enforcement Administration rules: 21 CFR parts 1300, 1301, 1302, 1304, 1305, 1306, 1311, 1314 and 1317. Food and Drug Administration rules: 21 CFR part 7 subpart C, part 208, sections 201.17, 201.100 and 290.5. Consumer Product Safety Commission: 16 CFR part 1700. Medicaid drug review: 42 CFR 456.705. Privacy and breach notification: 45 CFR part 164. The eCFR text read was dated 2026-09-30 for Title 21 and 2026-10-01 for Titles 16, 42 and 45. Licence: Own work. Every question, every wrong choice and every explanation was written for this site from the text of the regulation it cites. Short quoted phrases are from federal regulations, which are public law. Nothing is taken from a licensing or certification exam, a prep company, a review book or another practice test.

How it works

This pharmacy law and regulations practice test asks federal rules only, in eight topics. Every question was written from one section of the Code of Federal Regulations, read on October 4, 2026, and its explanation names that section.

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Federal law only

Practice for an exam, not medical advice. State pharmacy acts and board rules are not here, nor drug names, doses or calculations. Where a state rule is stricter, the question still asks what the federal section says.

Eight topics

The Start from menu under the question sets one: DEA registration and security, order forms, Schedule II prescriptions, Schedule III to V prescriptions, sales without a prescription, records and disposal, FDA labels and recalls, or the counseling offer and privacy.

Text in force

Amounts and time limits are those in the eCFR text dated September 30, 2026 for Title 21 and October 1, 2026 for Titles 16, 42 and 45. They change when the rules change.

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Questions and answers

What does this pharmacy law practice test cover?

Drug Enforcement Administration rules in 21 CFR parts 1300 to 1317, Food and Drug Administration rules on labels, Medication Guides and recalls, child-resistant packaging in 16 CFR part 1700, the Medicaid counseling standard in 42 CFR 456.705 and privacy rules in 45 CFR part 164.

Does it include state pharmacy law?

No. Each state has its own pharmacy act and board rules, and none is asked here. A state exam on pharmacy law tests that state's text, which this page has not read. The questions here stop at federal regulations.

Are these questions from a real pharmacy exam?

No. Every question, choice and explanation was written for this site from the public text of the regulations, not from a real exam or a prep book. Exam mode draws 25 questions; that length is this site's choice, and no pass mark is implied.

Why are there no questions on which drug is in which schedule?

Matching a drug to its schedule is a question about drugs, and this page keeps to procedure: registration, order forms, prescriptions, refills, records, labels and privacy. A drug is named only where the regulation itself names it.