I85PREP
⌘ K
MPJE study materials
MPJE study resources

MPJE practice questions

One question at a time. Build your MPJE understanding.

First 50 of 199 questions. Each one lists the choices, the correct answer, and an explanation. The checker at the top of this page saves progress in this browser when it is available.

Continue in the practice tool above to load more questions, 50 at a time.

Question 1Federal statutes, regulations, and agency guidance affecting pharmacy practice

A drug has a high potential for abuse, no currently accepted medical use in treatment in the United States, and lacks accepted safety for use under medical supervision. Under the Controlled Substances Act, this drug is placed in which schedule?

  1. Schedule I Correct answer.
  2. Schedule III
  3. Schedule II
  4. Schedule IV

Explanation

Schedule I is reserved for substances with high abuse potential, no currently accepted medical use in the United States, and a lack of accepted safety for use under medical supervision. Schedule II substances also have high abuse potential but do have accepted medical uses.

Question 2Federal statutes, regulations, and agency guidance affecting pharmacy practice

A community pharmacy registered with DEA to handle controlled substances must renew that registration at what interval?

  1. Every year
  2. Every 2 years
  3. Every 3 years Correct answer.
  4. Every 5 years

Explanation

DEA registrations are issued for a 36-month period, so a pharmacy renews its controlled substance registration every three years. Renewal must be completed before the expiration date for continued authority to handle controlled substances.

Question 3Federal statutes, regulations, and agency guidance affecting pharmacy practice

Which statement about a prescription for a Schedule II controlled substance is correct under federal law?

  1. It may be refilled without limit while the prescription is valid
  2. It may not be refilled Correct answer.
  3. It may be refilled up to five times within six months
  4. It may be refilled once if the prescriber authorizes

Explanation

Federal law prohibits refilling a Schedule II prescription; a new prescription is required for additional dispensing. Refills are permitted only for Schedule III, IV, and V prescriptions, subject to limits.

Question 4Federal statutes, regulations, and agency guidance affecting pharmacy practice

Under federal law, what is the maximum number of refills permitted on a prescription for a Schedule IV controlled substance?

  1. No refills
  2. Five refills Correct answer.
  3. One refill
  4. Three refills

Explanation

A prescription for a Schedule III, IV, or V controlled substance may be refilled up to five times, and each refill must occur within six months of the date the prescription was issued. The prescriber may authorize fewer refills.

Question 5Federal statutes, regulations, and agency guidance affecting pharmacy practice

Under the Combat Methamphetamine Epidemic Act, what is the maximum daily retail amount of pseudoephedrine base that may be sold to a single purchaser?

  1. 7.5 grams
  2. 9 grams
  3. 1.8 grams
  4. 3.6 grams Correct answer.

Explanation

The Combat Methamphetamine Epidemic Act caps retail sales of pseudoephedrine at 3.6 grams per purchaser per calendar day. It also caps sales at 9 grams per purchaser in a 30-day period.

Question 6Federal statutes, regulations, and agency guidance affecting pharmacy practice

A DEA Form 222 (or its electronic equivalent, CSOS) is used by a pharmacy to perform which function?

  1. Register a new pharmacy location with DEA
  2. Order Schedule I and Schedule II controlled substances Correct answer.
  3. Document the destruction of controlled substances
  4. Report the theft or loss of controlled substances

Explanation

DEA Form 222 is the order form used to transfer Schedule I and Schedule II controlled substances between registrants, such as a pharmacy purchasing from a distributor. It is not used for reporting losses, destruction, or registration.

Question 7Federal statutes, regulations, and agency guidance affecting pharmacy practice

A patient asks that a prescription be dispensed in a container that is not child resistant. Under the Poison Prevention Packaging Act, the pharmacist may comply under which circumstance?

  1. Only if the prescriber authorizes it in writing
  2. If the patient requests it Correct answer.
  3. Only for drugs that are not controlled substances
  4. Only if the pharmacy posts a public notice

Explanation

The Poison Prevention Packaging Act requires child-resistant packaging for most oral prescription drugs but allows noncomplying packaging when the prescriber directs it or when the purchaser requests it. The patient's request alone is sufficient.

Question 8Federal statutes, regulations, and agency guidance affecting pharmacy practice

Which disclosure is permitted under the HIPAA Privacy Rule without the patient's authorization?

  1. Disclosure of the full record to the patient's employer
  2. Disclosure to the patient's health plan to pay a claim Correct answer.
  3. Disclosure to a marketing firm promoting a new product
  4. Disclosure of psychotherapy notes to a family member

Explanation

Disclosures for treatment, payment, and health care operations do not require patient authorization, and submitting a claim to a health plan is a payment activity. Psychotherapy notes and marketing uses generally require specific authorization.

Question 9Federal statutes, regulations, and agency guidance affecting pharmacy practice

Which statement about the controlled substance inventory a DEA-registered pharmacy must take is correct?

  1. Exact counts are required for all schedules from II through V
  2. Exact counts are required for Schedule III through V and counts may be estimated for Schedule II
  3. Counts may be estimated for all schedules if purchase records are complete
  4. Exact counts are required for Schedule II and counts may be estimated for Schedule III through V Correct answer.

Explanation

A biennial inventory must be taken every two years, and Schedule II substances must be counted exactly. Schedule III, IV, and V substances may be estimated unless the container holds more than 1,000 tablets or capsules.

Question 10Federal statutes, regulations, and agency guidance affecting pharmacy practice

A pharmacy discovers that 200 oxycodone tablets are missing and finds no evidence of a break-in. Which DEA form is used to report this to the agency?

  1. DEA Form 222
  2. DEA Form 224
  3. DEA Form 41
  4. DEA Form 106 Correct answer.

Explanation

In-transit and significant losses of controlled substances are reported to DEA on Form 106, generally within one business day of discovery. The registrant must also notify local law enforcement when a theft is suspected.

Question 11Federal statutes, regulations, and agency guidance affecting pharmacy practice

A pharmacist who is not the DEA registrant needs to sign a DEA Form 222 to order Schedule II drugs for the pharmacy. What is required for this to be valid?

  1. The pharmacist must obtain a separate DEA registration for the pharmacy
  2. The registrant must execute a power of attorney naming the pharmacist as agent Correct answer.
  3. The distributor may accept the pharmacist's verbal order instead
  4. The pharmacist must file DEA Form 224 before signing

Explanation

A registrant may authorize one or more individuals to execute Form 222 by executing a power of attorney for each person. The power of attorney must be retained with the executed order forms and made available for inspection.

Question 12Federal statutes, regulations, and agency guidance affecting pharmacy practice

In a documented emergency, a pharmacist dispenses a Schedule II controlled substance on a prescriber's oral order. Within what period must the prescriber furnish a written or electronic prescription to the pharmacy?

  1. 14 days
  2. 5 days
  3. 72 hours
  4. 7 days Correct answer.

Explanation

When a Schedule II drug is dispensed on an emergency oral order, the prescriber must deliver a written or electronic prescription within seven days. If it is not received, the pharmacist must notify DEA.

Question 13Federal statutes, regulations, and agency guidance affecting pharmacy practice

Under federal law, which Schedule II prescription may lawfully be transmitted to the pharmacy by fax?

  1. A prescription for a patient younger than 18 years
  2. A prescription paid for in cash by the patient
  3. A prescription for a 90-day supply written by a family physician
  4. A prescription for a patient in a long-term care facility Correct answer.

Explanation

Faxed Schedule II prescriptions are permitted for patients in long-term care facilities, for patients receiving hospice care, and for compounded preparations for direct administration to a patient by a practitioner. Other Schedule II prescriptions must be written or electronic.

Question 14Federal statutes, regulations, and agency guidance affecting pharmacy practice

Under HIPAA, a covered entity must act on an individual's request for access to their protected health information within how many days?

  1. 60 days
  2. 15 days
  3. 10 days
  4. 30 days Correct answer.

Explanation

The HIPAA Privacy Rule requires a covered entity to provide requested access within 30 days of the request, with the possibility of one 30-day extension if certain conditions are met. A reasonable, cost-based fee may be charged.

Question 15Federal statutes, regulations, and agency guidance affecting pharmacy practice

A patient requests an accounting of disclosures of their protected health information. Which disclosure must generally be included in the accounting?

  1. Disclosures to a public health authority as required by law Correct answer.
  2. Disclosures to the patient's cardiologist for treatment
  3. Disclosures to the pharmacy for its own operations
  4. Disclosures to the health plan for payment

Explanation

An accounting of disclosures covers disclosures made outside of treatment, payment, and health care operations, including those required by law such as public health reporting. Disclosures for treatment, payment, and operations are excluded.

Question 16Federal statutes, regulations, and agency guidance affecting pharmacy practice

Which activity is permitted under the Prescription Drug Marketing Act?

  1. A manufacturer's representative gives samples to a prescriber Correct answer.
  2. A wholesaler sells samples to retail pharmacies
  3. A pharmacy returns dispensed samples to the manufacturer for credit
  4. A pharmacy sells samples to patients at a reduced price

Explanation

The Prescription Drug Marketing Act bars the sale, purchase, or trade of drug samples and prohibits their resale after dispensing. Manufacturers and their representatives may distribute samples to licensed practitioners who request them.

Question 17Federal statutes, regulations, and agency guidance affecting pharmacy practice

OBRA 1990 requires state Medicaid programs to provide which service at the point a prescription is dispensed?

  1. Reimbursement for all over-the-counter products
  2. A 90-day supply for all maintenance medications
  3. Mandatory generic substitution in every state
  4. Prospective drug utilization review before the prescription is dispensed Correct answer.

Explanation

OBRA 1990 established prospective and retrospective drug utilization review requirements for state Medicaid programs. Prospective review screens the prescription before dispensing for therapeutic duplication, interactions, and other problems.

Question 18Federal statutes, regulations, and agency guidance affecting pharmacy practice

Which feature is characteristic of a risk evaluation and mitigation strategy that includes elements to assure safe use?

  1. A boxed warning is added to the prescribing information
  2. Prescriber certification and patient enrollment are required before dispensing Correct answer.
  3. A Medication Guide is dispensed with each prescription
  4. A phase 4 clinical trial is required after approval

Explanation

Elements to assure safe use are the most restrictive REMS component and may include prescriber or dispenser certification, patient enrollment, and documentation of safe-use conditions before a drug may be dispensed. A Medication Guide alone is a less restrictive REMS element, not an element to assure safe use.

Question 19Federal statutes, regulations, and agency guidance affecting pharmacy practice

Under the Combat Methamphetamine Epidemic Act, which requirement applies to a retail sale of pseudoephedrine?

  1. The purchaser must provide a DEA registration number
  2. The sale must be reported to DEA within 24 hours
  3. The purchaser must be at least 21 years old
  4. The purchaser must sign a logbook and present photo identification Correct answer.

Explanation

Retail sellers must maintain a written or electronic logbook recording the purchaser's signature, name, address, and date and time of sale, and must verify identity with a photo ID. Regulated products must be kept behind the counter or in a locked cabinet.

Question 20Federal statutes, regulations, and agency guidance affecting pharmacy practice

A pharmacist receives a cash Schedule II prescription for a high dose of an opioid written by a prescriber hundreds of miles from the patient's home, and the pattern suggests misuse. Under DEA rules, the pharmacist:

  1. must resolve the red flags before dispensing Correct answer.
  2. should dispense and record only the prescriber's DEA number
  3. may dispense but must notify DEA within 24 hours
  4. must dispense any prescription valid on its face

Explanation

A pharmacist shares a corresponding responsibility with the prescriber to ensure a controlled substance prescription is issued for a legitimate medical purpose in the usual course of professional practice. Red flags must be resolved and documented before dispensing.

Question 21Federal statutes, regulations, and agency guidance affecting pharmacy practice

A single DEA Form 222 may list a maximum of how many line items?

  1. 10 Correct answer.
  2. 5
  3. 15
  4. 20

Explanation

Each DEA Form 222 contains ten numbered lines, so no more than ten items may be ordered on one form. If more items are needed, additional forms must be executed.

Question 22Federal statutes, regulations, and agency guidance affecting pharmacy practice

Under the Drug Supply Chain Security Act, how long must trading partners retain transaction information and transaction statements?

  1. 6 years Correct answer.
  2. 2 years
  3. 3 years
  4. 10 years

Explanation

DSCSA requires trading partners to retain transaction information and transaction statements for not less than six years after the date of the transaction. These records must be provided to FDA or authorized regulators upon request.

Question 23Federal statutes, regulations, and agency guidance affecting pharmacy practice

Which requirement applies to a 503B outsourcing facility but not to a traditional 503A compounding pharmacy?

  1. It must follow current good manufacturing practice and report serious adverse events Correct answer.
  2. It may compound only nonsterile products
  3. It must obtain a patient-specific prescription before compounding
  4. It is exempt from FDA inspection

Explanation

A 503B outsourcing facility must comply with current good manufacturing practice and report serious adverse events to FDA, among other requirements. Section 503A pharmacies compound only pursuant to patient-specific prescriptions or limited anticipatory orders.

Question 24Federal statutes, regulations, and agency guidance affecting pharmacy practice

A new drug application holder learns of a serious and unexpected adverse event associated with its product. Under FDA regulations, the report must be submitted within how many calendar days?

  1. 30 calendar days
  2. 5 calendar days
  3. 10 calendar days
  4. 15 calendar days Correct answer.

Explanation

Applicants must report serious and unexpected adverse drug experiences to FDA within 15 calendar days of initial receipt of the information. Fatal or life-threatening unexpected events must be reported by telephone or fax within 7 calendar days.

Question 25Federal statutes, regulations, and agency guidance affecting pharmacy practice

The FDA's Pregnancy and Lactation Labeling Rule replaced which prior labeling format?

  1. The generally recognized as safe statement
  2. The pregnancy letter categories A, B, C, D, and X Correct answer.
  3. The boxed warning format
  4. The pediatric exclusivity designation

Explanation

The Pregnancy and Lactation Labeling Rule phased out the A, B, C, D, and X pregnancy categories in favor of narrative sections on pregnancy, lactation, and use in specific populations. The rule applies to prescription drug and biologic labeling.

Question 26Federal statutes, regulations, and agency guidance affecting pharmacy practice

Which federal statute first established a distinct class of drugs that could be dispensed only on the order of a licensed prescriber?

  1. The Kefauver-Harris Amendment of 1962
  2. The Federal Food, Drug, and Cosmetic Act of 1938
  3. The Prescription Drug Marketing Act of 1987
  4. The Durham-Humphrey Amendment of 1951 Correct answer.

Explanation

The Durham-Humphrey Amendment divided drugs into prescription (legend) and over-the-counter categories and limited legend drugs to dispensing on a prescriber's order. It also authorized oral prescriptions and refills for legend drugs under federal law.

Question 27Federal statutes, regulations, and agency guidance affecting pharmacy practice

Under the federal Controlled Substances Act, how many times may a pharmacy refill a prescription for a Schedule II controlled substance?

  1. Up to five times, as long as all refills occur within six months
  2. Up to three times, if the prescriber authorizes refills on the original
  3. None; refilling a Schedule II prescription is prohibited Correct answer.
  4. Once, if the prescriber specifically authorizes a single refill

Explanation

Federal law bars refilling a Schedule II prescription, so a new prescription is needed for each dispensing. A state may add stricter rules but cannot authorize Schedule II refills.

Question 28Federal statutes, regulations, and agency guidance affecting pharmacy practice

A prescriber authorizes refills on a Schedule IV prescription. Under federal law, the prescription may be refilled:

  1. Once only, within 90 days of the date the prescription is issued
  2. Unlimited refills for one year from the date the prescription is issued
  3. Up to five times within six months of the issue date Correct answer.
  4. Up to five times with no limit on the total time period

Explanation

For Schedule III and IV prescriptions, federal law permits as many as five refills, and no refill may be dispensed more than six months after the prescription was issued. Each partial refill counts toward the five-refill maximum.

Question 29Federal statutes, regulations, and agency guidance affecting pharmacy practice

How often must a DEA-registered pharmacy renew its DEA registration?

  1. Every five years
  2. Every three years Correct answer.
  3. Every two years
  4. Every year

Explanation

DEA registrations for pharmacies and practitioners are valid for three years and must be renewed before expiration to continue handling controlled substances. Operating on an expired registration is unlawful.

Question 30Federal statutes, regulations, and agency guidance affecting pharmacy practice

Under DEA regulations, how long must a registered pharmacy retain records of controlled substances received and dispensed?

  1. Two years Correct answer.
  2. One year
  3. Five years
  4. Three years

Explanation

Registrants must keep complete and accurate records of controlled substances received, sold, dispensed, or otherwise disposed of for at least two years. The records must be maintained at the registered location and be readily retrievable.

Question 31Federal statutes, regulations, and agency guidance affecting pharmacy practice

After discovering a breach of unsecured protected health information, a covered entity must notify affected individuals without unreasonable delay and no later than:

  1. 90 days after discovery
  2. 60 days after discovery Correct answer.
  3. 15 days after discovery
  4. 30 days after discovery

Explanation

The HIPAA Breach Notification Rule requires notice to affected individuals without unreasonable delay and in no case later than 60 calendar days after discovery of the breach. Larger breaches also trigger notice to the media and to HHS.

Question 32Federal statutes, regulations, and agency guidance affecting pharmacy practice

The Kefauver-Harris Amendment of 1962 added which requirement to the new drug approval process?

  1. A risk evaluation and mitigation strategy for the drug
  2. A demonstration of bioequivalence to an approved reference product
  3. A certification that the drug is not covered by any patent
  4. Substantial evidence of effectiveness in addition to safety Correct answer.

Explanation

Kefauver-Harris required that a new drug application demonstrate substantial evidence of effectiveness as well as safety. It also shifted responsibility for reviewing investigational drug use to FDA and strengthened informed consent requirements.

Question 33Federal statutes, regulations, and agency guidance affecting pharmacy practice

The labeling of a prescription drug product must bear which statement to distinguish it from an over-the-counter drug?

  1. Rx only Correct answer.
  2. Warning: may cause drowsiness
  3. For external use only
  4. Keep out of reach of children

Explanation

FDA regulations require prescription drug labeling to bear the symbol "Rx only," which replaced the older legend statement. The other statements are cautionary labeling elements that may appear on certain products but do not designate prescription status.

Question 34Federal statutes, regulations, and agency guidance affecting pharmacy practice

A pharmacist sends a patient's medication list to the patient's cardiologist to coordinate care. Which statement about the HIPAA minimum necessary standard is correct?

  1. The pharmacist may send only the single medication that prompted the referral
  2. The pharmacist must obtain the patient's written authorization before sending the list
  3. The pharmacist must limit the disclosure to the minimum necessary for the cardiologist's payment activities
  4. The minimum necessary standard does not apply to disclosures to a provider for treatment Correct answer.

Explanation

Minimum necessary governs most uses and disclosures of protected health information, but it expressly does not apply to disclosures to a health care provider for treatment or to disclosures to the individual. Sending the full medication list for treatment purposes is therefore permissible.

Question 35Federal statutes, regulations, and agency guidance affecting pharmacy practice

Which of the following products is exempt from the child-resistant packaging requirements of the Poison Prevention Packaging Act?

  1. Amoxicillin oral suspension
  2. Immediate-release oxycodone tablets
  3. Pediatric acetaminophen oral suspension
  4. Sublingual nitroglycerin tablets Correct answer.

Explanation

FDA regulations exempt certain products from child-resistant packaging, including sublingual dosage forms of nitroglycerin and sublingual or chewable isosorbide dinitrate. Most oral prescription products, including opioids and antibiotic suspensions, must be dispensed in child-resistant containers.

Question 36Federal statutes, regulations, and agency guidance affecting pharmacy practice

Under the Drug Supply Chain Security Act, after a trading partner determines that a product in its possession is illegitimate, the partner must notify FDA and other affected trading partners in the supply chain within:

  1. 3 business days
  2. 10 calendar days
  3. 24 hours Correct answer.
  4. 30 calendar days

Explanation

The DSCSA requires a trading partner that determines a product is illegitimate to notify FDA and immediate trading partners as soon as possible and no later than 24 hours after the determination. Related suspect product investigations use a separate, longer timeline.

Question 37Federal statutes, regulations, and agency guidance affecting pharmacy practice

An applicant submitting an abbreviated new drug application must establish which of the following?

  1. Clinical superiority over the reference listed drug
  2. Full safety and efficacy data from new clinical trials sponsored by the applicant
  3. Bioequivalence to the reference listed drug Correct answer.
  4. That the active ingredient is a new chemical entity

Explanation

An ANDA relies on FDA's prior findings of safety and effectiveness for the reference listed drug, so the applicant must instead show bioequivalence and adequate chemistry, manufacturing, and labeling. It also must address patents covering the reference drug.

Question 38Federal statutes, regulations, and agency guidance affecting pharmacy practice

FDA assigns a recall to Class I when:

  1. Use of the product may cause serious adverse health consequences or death Correct answer.
  2. The product has a labeling defect that could mislead prescribers about dosing
  3. The product is unlikely to cause any adverse health consequences
  4. The product causes only temporary or medically reversible harm

Explanation

Class I is reserved for situations in which there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II covers temporary or reversible harm, and Class III covers violations unlikely to cause harm.

Question 39Federal statutes, regulations, and agency guidance affecting pharmacy practice

A drug granted pediatric exclusivity receives an additional period of market exclusivity of:

  1. Six months Correct answer.
  2. Two years
  3. One year
  4. Three months

Explanation

When a sponsor completes requested pediatric studies, FDA may attach an additional six months of exclusivity to existing patent or nonpatent exclusivity. The six months is added to the end of the existing protection rather than running concurrently.

Question 40Federal statutes, regulations, and agency guidance affecting pharmacy practice

A DEA-registered pharmacy needs to destroy outdated controlled substances on site. Which DEA form documents this destruction?

  1. DEA Form 106
  2. DEA Form 224
  3. DEA Form 41 Correct answer.
  4. DEA Form 222

Explanation

DEA Form 41 is the record of destruction used to document controlled substances destroyed by a registrant. Form 106 reports theft or significant loss, Form 222 orders Schedule I and II substances, and Form 224 is the application for registration.

Question 41Federal statutes, regulations, and agency guidance affecting pharmacy practice

A prescriber issues a Schedule II prescription for a terminally ill patient for 120 tablets and notes that the patient may need the quantity in installments. Under DEA rules, the remaining portions must be dispensed no later than:

  1. 90 days from the date of issue
  2. Six months from the date of issue
  3. 30 days from the date of issue
  4. 60 days from the date of issue Correct answer.

Explanation

Partial filling of a Schedule II prescription is permitted for patients in a long-term care facility or with a terminal illness, provided all remaining portions are dispensed within 60 days of the date the prescription was written. Otherwise, a partial fill for insufficient supply must be completed within 72 hours.

Question 42Federal statutes, regulations, and agency guidance affecting pharmacy practice

The federal Anti-Kickback Statute prohibits:

  1. Knowingly offering remuneration to induce referrals of federally payable items Correct answer.
  2. A wholesaler giving a pharmacy a volume discount that is disclosed in the purchase agreement
  3. Dispensing a drug that does not appear on a payer's formulary because the prescriber requested it
  4. Providing a patient, on request, a copy of the patient's own prescription records

Explanation

The statute makes it a criminal offense to knowingly and willfully offer, pay, solicit, or receive remuneration to induce referrals for items or services reimbursable by a federal health care program. Discounts are analyzed under the statute and its safe harbors, and properly structured bona fide discounts may be protected.

Question 43Federal statutes, regulations, and agency guidance affecting pharmacy practice

A pharmacy hires an outside vendor to perform billing services that require access to protected health information. What must the pharmacy do before sharing the information?

  1. Execute a written business associate agreement with the vendor Correct answer.
  2. Post a notice describing the arrangement on the pharmacy's public website
  3. Notify the HHS Office for Civil Rights within 30 days of the arrangement
  4. Obtain a written authorization from each affected patient

Explanation

A covered entity may disclose protected health information to a business associate only after obtaining satisfactory written assurances that the associate will safeguard the information. That contract, the business associate agreement, must address permitted uses, safeguards, and breach reporting.

Question 44Federal statutes, regulations, and agency guidance affecting pharmacy practice

A pharmacy corporation opens a second location in the same state. Regarding DEA registration, the corporation must:

  1. Obtain a modified registration from the state board of pharmacy only
  2. Notify DEA within 30 days and keep operating under the original registration number
  3. Use the existing registration at the new location until it comes up for renewal
  4. Obtain a separate DEA registration for each principal place of business Correct answer.

Explanation

A separate DEA registration is required for each principal place of business or professional practice where controlled substances are handled. A state pharmacy license does not substitute for federal registration at the new site.

Question 45Federal statutes, regulations, and agency guidance affecting pharmacy practice

A pharmacy sells a Schedule V cough preparation without a prescription. Which federal requirement applies?

  1. The sale must be recorded on a DEA Form 222
  2. The purchaser must be at least 18 and the sale must be recorded Correct answer.
  3. The product must be kept behind the counter, with no record required
  4. The sale may not occur without a prescriber's oral order

Explanation

Dispensing a Schedule V controlled substance without a prescription requires that the purchaser be at least 18 years old and present appropriate identification, and the pharmacist must keep a written or electronic record of the sale. The record identifies the purchaser, the product, the quantity, and the date.

Question 46Federal statutes, regulations, and agency guidance affecting pharmacy practice

A 2023 DEA final rule permits which of the following for electronic prescriptions for controlled substances?

  1. Use of a shared password by pharmacists at the same store
  2. Transmission of a Schedule II prescription directly to the patient by email
  3. Transfer of an unfilled electronic prescription to another pharmacy Correct answer.
  4. Refilling a Schedule II electronic prescription up to five times

Explanation

DEA now permits a pharmacy to transfer an unfilled electronic prescription for a Schedule II through V controlled substance to another pharmacy for initial filling, subject to documentation and pharmacy-to-pharmacy communication requirements. Refills of Schedule II prescriptions and shared credentials remain prohibited.

Question 47Federal statutes, regulations, and agency guidance affecting pharmacy practice

Which statement about 180-day exclusivity under the Hatch-Waxman Amendments is correct?

  1. It is granted automatically to every applicant that files a Paragraph IV certification
  2. It applies only to biologics licensed under a biologics license application
  3. It lasts five years and blocks every subsequent ANDA from being approved
  4. It is awarded to the first ANDA applicant that files a Paragraph IV certification Correct answer.

Explanation

The first applicant to submit a substantially complete ANDA containing a Paragraph IV certification earns 180 days of exclusivity against later Paragraph IV filers. Certain later applicants, such as one that obtains a court decision of invalidity or noninfringement, may share in that exclusivity.

Question 48Federal statutes, regulations, and agency guidance affecting pharmacy practice

Under the Ryan Haight Act, a practitioner generally may prescribe a controlled substance via telemedicine only if:

  1. The practitioner has conducted an in-person evaluation or meets an exception Correct answer.
  2. The prescription is transmitted by fax rather than electronically
  3. The patient signs a written waiver of the in-person examination requirement
  4. The prescription is limited to a 30-day supply of the controlled substance

Explanation

The Ryan Haight Act requires at least one in-person medical evaluation before a practitioner may prescribe a controlled substance by means of the internet, unless a specified exception applies, such as treatment in a DEA-registered facility or an applicable public health emergency flexibility. The required evaluation must occur before the telemedicine prescribing.

Question 49Federal statutes, regulations, and agency guidance affecting pharmacy practice

A traditional 503A compounding pharmacy generally may not compound a drug that is essentially a copy of a commercially available product unless:

  1. The compounded preparation is priced lower than the commercial product
  2. The commercial product is on FDA's drug shortage list Correct answer.
  3. The patient's prescriber signs a waiver of the prohibition
  4. The pharmacy compounds the preparation fewer than ten times per month

Explanation

Section 503A excludes from the exempt compounding definition drugs that are essentially copies of a commercially available product, unless the prescriber determines a change produces a significant difference for the patient or the commercial product appears on FDA's drug shortage list. Price and volume do not create an exception.

Question 50Federal statutes, regulations, and agency guidance affecting pharmacy practice

Under the HIPAA Privacy Rule, which statement about psychotherapy notes is correct?

  1. They are part of the designated record set and must be produced on an access request
  2. They may be disclosed to a health plan for care coordination without authorization
  3. They require a specific patient authorization for most disclosures Correct answer.
  4. They may be disclosed for payment purposes without authorization

Explanation

Psychotherapy notes receive heightened protection and generally may be used or disclosed only with a specific authorization, apart from narrow exceptions such as the originator's own treatment use and certain oversight functions. They are also excluded from the designated record set for access purposes.