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NJ MPJE practice questions

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Question 1Federal Food, Drug, and Cosmetic Act and federal prescription requirements

A pharmacist dispenses a legend drug to a patient without any prescription from a licensed practitioner. Under the Federal Food, Drug, and Cosmetic Act, the dispensed drug is best characterized as:

  1. an unapproved new drug
  2. adulterated
  3. a counterfeit drug
  4. misbranded Correct answer.

Explanation

Section 503(b)(1) of the FDCA permits a prescription drug to be dispensed only on a prescription of a practitioner licensed by law, and the drug's exemption from the adequate-directions-for-use labeling requirement depends on dispensing pursuant to a prescription. When it is handed out without one, the product lacks adequate directions for use and is therefore misbranded. Adulteration, by contrast, concerns the physical condition or manufacture of the product rather than the absence of a prescription.

Question 2Federal Food, Drug, and Cosmetic Act and federal prescription requirements

Under DEA regulations, how many times may a pharmacist refill a prescription written for a Schedule II controlled substance?

  1. Not at all Correct answer.
  2. Up to five times within six months
  3. Up to five times within five months
  4. Once, with the prescriber's authorization

Explanation

Federal regulations provide that no prescription for a Schedule II controlled substance may be refilled. The patient must obtain a new prescription from the practitioner for each dispensing. Refill authority exists only for Schedule III, IV, and V prescriptions.

Question 3Federal Food, Drug, and Cosmetic Act and federal prescription requirements

A prescriber issues a prescription for a Schedule IV controlled substance. Under federal law, the prescription may be refilled:

  1. four times within six months
  2. three times within six months
  3. five times within six months Correct answer.
  4. six times within six months

Explanation

21 CFR 1306.22 permits a prescription for a Schedule III or IV controlled substance to be refilled up to five times, and the prescription becomes void six months after the date it was issued. A Schedule V prescription may be refilled as authorized by state law. Any refill must also be authorized by the prescriber on the face of the prescription.

Question 4Federal Food, Drug, and Cosmetic Act and federal prescription requirements

A prescriber telephones an emergency oral prescription for a Schedule II controlled substance. Within what period must the prescriber furnish the pharmacy with a written prescription?

  1. 10 days
  2. 7 days Correct answer.
  3. 3 days
  4. 5 days

Explanation

When an emergency oral order for a Schedule II controlled substance is permitted, 21 CFR 1306.11(d) requires the prescriber to deliver a written prescription to the dispensing pharmacy within seven days. Only the quantity needed to treat the patient during the emergency period may be dispensed. If the written prescription is not received, the pharmacist must notify DEA.

Question 5Federal Food, Drug, and Cosmetic Act and federal prescription requirements

Which element must appear on a prescription for a controlled substance for the prescription to be valid under federal law?

  1. the manufacturer's NDC number
  2. the pharmacy's NPI number
  3. the patient's insurance ID
  4. the prescriber's DEA number Correct answer.

Explanation

21 CFR 1306.05(a) requires that a controlled substance prescription be dated, signed by the practitioner, and bear the practitioner's name, address, and DEA registration number, along with the patient's name and address and the drug details. Insurance identifiers, pharmacy NPIs, and manufacturer NDCs are not federal validity requirements.

Question 6Federal Food, Drug, and Cosmetic Act and federal prescription requirements

Under 21 CFR 290.5, the label affixed to a prescription drug dispensed to a patient must include which of the following?

  1. the stock bottle's expiration date
  2. the wholesaler's name
  3. directions for use Correct answer.
  4. the drug's NDC number

Explanation

The federal dispensing label must show the name and address of the dispenser, the serial number and date of the prescription, the prescriber's name, the patient's name if stated on the prescription, and the directions for use and cautionary statements contained in the prescription. Requirements such as the NDC number or wholesaler identity are not part of this federal list.

Question 7Federal Food, Drug, and Cosmetic Act and federal prescription requirements

A community pharmacy sells over-the-counter pseudoephedrine tablets. Under the Combat Methamphetamine Epidemic Act, the pharmacy must:

  1. record the customer's date of birth for sales over 3.6 grams
  2. store the product behind the counter and log each sale Correct answer.
  3. require a prescription for every retail sale
  4. place the product on an open shelf near the pharmacy counter

Explanation

The CMEA requires that scheduled listed chemical products such as pseudoephedrine be kept where customers cannot access them without assistance, and that sellers maintain a written or electronic logbook of each sale showing the purchaser's name, address, date and time, and product and quantity. Sales are also subject to daily and monthly gram limits and photo identification requirements.

Question 8Federal Food, Drug, and Cosmetic Act and federal prescription requirements

A pharmacy purchases a supply of Schedule II controlled substances from its wholesaler. Which document must be used to record the transaction?

  1. DEA Form 41
  2. DEA Form 222 Correct answer.
  3. DEA Form 106
  4. a standard invoice

Explanation

Schedule II controlled substances are transferred between registrants using DEA Form 222 (or its electronic equivalent through CSOS), with copies retained by both parties. An invoice alone is insufficient for Schedule II drugs, although invoices are used for Schedule III through V transactions.

Question 9Federal Food, Drug, and Cosmetic Act and federal prescription requirements

An investigational new drug sponsor must submit an expedited safety report to FDA within 15 calendar days when it receives information about an adverse event that is:

  1. serious and expected
  2. nonserious and unexpected
  3. serious and unexpected Correct answer.
  4. nonserious and expected

Explanation

21 CFR 314.80 requires an expedited written report within 15 calendar days for adverse drug experiences that are both serious and unexpected, including reports of an increased rate of occurrence of a serious suspected reaction. Other serious events are reported periodically, and nonserious events are handled through periodic reporting.

Question 10Federal Food, Drug, and Cosmetic Act and federal prescription requirements

A drug product is deemed adulterated under the FDCA when it is:

  1. sold without a prescription
  2. held under insanitary conditions Correct answer.
  3. labeled with a misleading established name
  4. marketed without adequate directions for use

Explanation

Section 501(a)(2)(A) of the FDCA treats a drug as adulterated if it has been prepared, packed, or held under insanitary conditions that may have rendered it contaminated or injurious to health. The other listed defects concern the label or the manner of sale and fall under the misbranding provisions of section 502.

Question 11Federal Food, Drug, and Cosmetic Act and federal prescription requirements

An abbreviated new drug application may be approved for a generic product when the applicant demonstrates that the product is:

  1. a new chemical entity never previously approved
  2. bioequivalent to the reference listed drug Correct answer.
  3. approved under an IND for a rare disease
  4. safe and effective in two adequate well-controlled trials

Explanation

An ANDA relies on the agency's prior finding of safety and effectiveness for the reference listed drug and requires instead a showing of pharmaceutical equivalence and bioequivalence, along with chemistry, manufacturing, and labeling information. New clinical trials are not required for ANDA approval.

Question 12Federal Food, Drug, and Cosmetic Act and federal prescription requirements

An oral prescription drug must be dispensed in a child-resistant container under the Poison Prevention Packaging Act unless:

  1. the prescriber or patient requests otherwise Correct answer.
  2. the patient agrees to pay a higher copayment
  3. the drug is a controlled substance
  4. the pharmacy has run out of such containers

Explanation

The PPPA requires child-resistant packaging for oral prescription drugs, but the prescribing practitioner may direct noncomplying packaging, and a patient may request a noncomplying container for a specific drug. A pharmacy's inventory shortage is not an authorized exception.

Question 13Federal Food, Drug, and Cosmetic Act and federal prescription requirements

Under the Prescription Drug Marketing Act, a prescription drug sample may lawfully be distributed to:

  1. a pharmacy for storage by the sales representative
  2. a licensed practitioner who requests it Correct answer.
  3. any licensed wholesaler for resale
  4. a hospital for inpatient use without a request

Explanation

The PDMA permits manufacturers and authorized distributors to provide drug samples only in response to a written request from a licensed practitioner, and the samples may not be sold or resold. Records of sample distribution must be maintained and periodic inventories conducted. Samples may not be commingled with stock intended for resale.

Question 14Federal Food, Drug, and Cosmetic Act and federal prescription requirements

A prescriber writes a Schedule II prescription for a patient in a long-term care facility. The pharmacist may partially fill the prescription and fill the remaining portions:

  1. within 72 hours of the first partial fill
  2. within 30 days of the issue date
  3. within 60 days of the issue date Correct answer.
  4. only after a new prescription is issued

Explanation

DEA regulations allow a Schedule II prescription to be partially filled for patients in a long-term care facility or for a patient with a terminal illness, with the remaining portions supplied within 60 days of the date the prescription was issued. After that period, a new prescription is required.

Question 15Federal Food, Drug, and Cosmetic Act and federal prescription requirements

A prescriber wants to issue electronic prescriptions for controlled substances. Under DEA regulations, the prescriber's electronic prescribing system must verify the practitioner's identity and require:

  1. two-factor authentication Correct answer.
  2. a single password log-in
  3. shared credentials with the practice manager
  4. a biometric factor used alone

Explanation

The electronic prescriptions for controlled substances rule requires identity proofing and credentialing of each prescriber and the use of two-factor authentication, in which one factor is something the prescriber knows and the other is something the prescriber has or is. Access must also be tracked through audit trails.

Question 16Federal Food, Drug, and Cosmetic Act and federal prescription requirements

A manufacturer markets a product as a dietary supplement. Which statement must appear on its label to satisfy the FDCA?

  1. FDA approved
  2. Dietary Supplement Correct answer.
  3. Caution: federal law prohibits dispensing without a prescription
  4. Rx only

Explanation

Under the Dietary Supplement Health and Education Act, a supplement's label must identify the product with the term 'dietary supplement' as part of its statement of identity. Structure/function claims must carry the required disclaimer and notification to FDA, and the product may not bear a legend statement reserved for prescription drugs.

Question 17Federal Food, Drug, and Cosmetic Act and federal prescription requirements

Which statement is true of an outsourcing facility registered under section 503B of the FDCA?

  1. It may not compound sterile preparations
  2. It may compound without a patient-specific prescription Correct answer.
  3. It is exempt from current good manufacturing practice requirements
  4. It is regulated only by the state board of pharmacy

Explanation

A 503B outsourcing facility may compound drug products without receiving a patient-specific prescription, which distinguishes it from a traditional 503A pharmacy. In exchange, it must register with FDA, report its compounded products, and comply with current good manufacturing practice requirements.

Question 18Federal Food, Drug, and Cosmetic Act and federal prescription requirements

Which component of a risk evaluation and mitigation strategy can restrict dispensing to certified pharmacies or prescribers?

  1. a patient package insert
  2. elements to assure safe use Correct answer.
  3. a medication guide
  4. a dear health care professional letter

Explanation

Elements to assure safe use are the REMS component that may impose certification of prescribers and pharmacies, training, restricted distribution, or documentation of safe-use conditions. A medication guide is a patient labeling document and does not itself restrict who may prescribe or dispense.

Question 19Federal Food, Drug, and Cosmetic Act and federal prescription requirements

FDA classifies a recall as Class I when:

  1. a labeling violation is found with no expected patient harm
  2. there is a reasonable probability of serious harm or death Correct answer.
  3. use will cause only temporary or reversible harm
  4. the product is unlikely to cause adverse health consequences

Explanation

A Class I recall involves a reasonable probability that use of, or exposure to, a violative product will cause serious adverse health consequences or death. Class II covers products that may cause temporary or medically reversible harm, and Class III covers products unlikely to cause adverse health consequences.

Question 20Federal Food, Drug, and Cosmetic Act and federal prescription requirements

Before a pharmacy accepts a prescription drug product from a trading partner, the Drug Supply Chain Security Act requires the pharmacy to receive which of the following?

  1. FDA prior notice of release
  2. a DEA Form 222 signed by the buyer
  3. a certificate of analysis from the manufacturer
  4. transaction data and a statement Correct answer.

Explanation

Dispensers must receive transaction information, transaction history, and a transaction statement from the seller before accepting a prescription drug product, and must retain those records. These documents allow the product to be traced through the distribution chain and confirm the seller's compliance status.

Question 21Federal Controlled Substances Act (schedules, registration, ordering, records, security)

Under the federal Controlled Substances Act, a substance is placed in Schedule I when the findings show which combination?

  1. Accepted medical use and a high potential for abuse
  2. No accepted medical use and a low potential for abuse
  3. No accepted medical use and a high potential for abuse Correct answer.
  4. Accepted medical use and a low potential for abuse

Explanation

Schedule I requires a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use under medical supervision. The presence of an accepted medical use moves a drug out of Schedule I regardless of its abuse potential. Heroin and LSD are standard examples.

Question 22Federal Controlled Substances Act (schedules, registration, ordering, records, security)

Which of the following medications is listed in Schedule II under federal law?

  1. Ketamine
  2. Zolpidem
  3. Alprazolam
  4. Hydromorphone Correct answer.

Explanation

Hydromorphone is an opioid agonist listed in Schedule II. Alprazolam and zolpidem are Schedule IV, and ketamine is Schedule III.

Question 23Federal Controlled Substances Act (schedules, registration, ordering, records, security)

A community pharmacy needs to order oxycodone tablets from its wholesaler. Which DEA form must the pharmacy use for this order?

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

Explanation

Schedule I and Schedule II substances must be ordered from a supplier on a DEA Form 222, or electronically through the CSOS system. Form 41 documents destruction, Form 106 reports theft or loss, and Form 224 is the registration application.

Question 24Federal Controlled Substances Act (schedules, registration, ordering, records, security)

How long must a registered pharmacy keep its records of controlled substance receipts and distributions?

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

Explanation

Federal regulations require controlled substance records and inventories to be kept at the registered location for at least two years and to be available for inspection. If state law demands a longer retention period, the longer period controls.

Question 25Federal Controlled Substances Act (schedules, registration, ordering, records, security)

A DEA registration issued to a retail pharmacy remains valid for how long before renewal is required?

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

Explanation

Registrations issued to practitioners, including pharmacies, are valid for three years from the date of issuance. The registrant must renew before the expiration date to avoid a lapse in authority to handle controlled substances.

Question 26Federal Controlled Substances Act (schedules, registration, ordering, records, security)

Federal regulation requires a registrant to take a complete inventory of all controlled substances on hand how often?

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

Explanation

A registrant takes an initial inventory when it first begins handling controlled substances, then a biennial inventory every two years thereafter on any date it chooses. The inventory is retained with the registrant's other controlled substance records.

Question 27Federal Controlled Substances Act (schedules, registration, ordering, records, security)

A pharmacy discovers that several dosage units of oxycodone are unaccounted for and suspects theft. Which form must the pharmacy use to notify DEA?

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

Explanation

Theft or significant loss of controlled substances must be reported in writing to the DEA field division office, with DEA Form 106 completed and submitted. The registrant must also conduct an accountability investigation to determine the nature and extent of the loss.

Question 28Federal Controlled Substances Act (schedules, registration, ordering, records, security)

A pharmacy wants its two lead technicians to be able to sign Schedule II order forms with the wholesaler. What is the correct procedure?

  1. Execute a power of attorney for each technician and keep it on file Correct answer.
  2. Have each technician obtain an individual DEA registration number
  3. Submit a written request to DEA to approve each technician
  4. List the technicians by name on the biennial inventory

Explanation

A registrant authorizes individuals to execute Form 222 orders by executing a power of attorney for each person. The power of attorney is retained with the executed order forms and made available for inspection; it is not sent to DEA for approval.

Question 29Federal Controlled Substances Act (schedules, registration, ordering, records, security)

After signing a DEA Form 222, the purchaser notices that the quantity entered on one line is incorrect. What does federal regulation require?

  1. Cross out the quantity, write the correct amount, and initial the change
  2. Submit the altered form to the DEA field office for approval
  3. Return all copies to the supplier with a statement of error Correct answer.
  4. Enter the corrected quantity on the last copy only

Explanation

Entries on a Form 222 may not be altered once the form has been executed. If the purchaser discovers an error, all copies go back to the supplier with a statement noting the error, and the purchaser issues a new, correct form.

Question 30Federal Controlled Substances Act (schedules, registration, ordering, records, security)

Federal law limits over-the-counter distribution of a Schedule V liquid to how much per purchaser in a 48-hour period?

  1. 480 mL
  2. 1,000 mL
  3. 240 mL Correct answer.
  4. 120 mL

Explanation

A pharmacist may dispense a Schedule V substance without a prescription only in limited amounts, generally no more than 240 mL of a liquid or 120 dosage units of a solid per purchaser in any 48-hour period. Stricter state limits may apply and must be followed.

Question 31Federal Controlled Substances Act (schedules, registration, ordering, records, security)

A combination product containing codeine is placed in Schedule III only if the codeine content per dosage unit does not exceed which amount?

  1. 60 mg
  2. 30 mg
  3. 90 mg Correct answer.
  4. 180 mg

Explanation

Schedule III covers codeine combination products whose codeine content does not exceed 90 mg per dosage unit and that contain one or more active non-narcotic medicinal ingredients. A product exceeding that threshold is placed in Schedule II.

Question 32Federal Controlled Substances Act (schedules, registration, ordering, records, security)

A prescriber gives a pharmacy an emergency oral order for a Schedule II analgesic. Within what period must the prescriber's written prescription reach the pharmacy?

  1. Two business days
  2. Fourteen days
  3. Three days
  4. Seven days Correct answer.

Explanation

In a genuine emergency, a pharmacist may dispense a Schedule II drug on an oral order if the prescriber delivers a written or electronic prescription within seven days. If the follow-up prescription is not received, the pharmacist must notify DEA.

Question 33Federal Controlled Substances Act (schedules, registration, ordering, records, security)

A patient asks the pharmacy to fill only half of a Schedule II prescription now, and the patient is not terminally ill or in long-term care. The remainder must be dispensed within how many days of the date the prescription was written?

  1. 30 days Correct answer.
  2. Six months
  3. 72 hours
  4. 60 days

Explanation

A Schedule II prescription may be partially filled at the request of the patient or the prescriber, but the remaining quantity must be dispensed within 30 days of the date written. For patients in long-term care or with a terminal illness, the remainder may be dispensed up to 60 days after the date written.

Question 34Federal Controlled Substances Act (schedules, registration, ordering, records, security)

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

  1. Up to three times within one year of the date of issue
  2. Only once, within thirty days
  3. Up to five times within six months of the date of issue Correct answer.
  4. Any number of times during the prescriber's registration period

Explanation

A Schedule III or IV prescription may not be filled or refilled more than six months after the date of issue and may not be refilled more than five times unless the prescriber renews it. Schedule II prescriptions may not be refilled at all.

Question 35Federal Controlled Substances Act (schedules, registration, ordering, records, security)

A pharmacy destroys its expired controlled substance stock on site using a DEA-approved method. Which form documents that destruction?

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

Explanation

Registrants record the destruction of controlled substances on DEA Form 41, which lists the items destroyed, the date, and the persons witnessing the destruction. The completed form is kept as part of the registrant's controlled substance records.

Question 36Federal Controlled Substances Act (schedules, registration, ordering, records, security)

A pharmacy that already holds a DEA registration opens a second store across town under the same ownership. What does DEA require at the new location?

  1. Only a new state pharmacy license for the second address
  2. A notice to DEA within thirty days after the new store opens
  3. Nothing, because one registration covers all locations with common ownership
  4. A separate DEA registration for the new location before dispensing Correct answer.

Explanation

A separate DEA registration is required for each principal place of business or professional practice where controlled substances are dispensed or stored. Operating at an unregistered location violates the CSA even when the same owner holds another registration.

Question 37Federal Controlled Substances Act (schedules, registration, ordering, records, security)

A wholesaler notices that a customer pharmacy has sharply increased its purchases of a Schedule II opioid. Federal regulation requires the wholesaler to:

  1. Record the order in the wholesaler's biennial inventory
  2. Report the suspicious order to the DEA field division office Correct answer.
  3. Cancel the order and refer the matter to the state board of pharmacy
  4. Deliver the order and note the concern in the customer's file

Explanation

Distributors must design and operate a system to identify suspicious orders and, on discovering one, must inform the DEA field division office in writing. Shipping may be held pending clarification, but the duty to report exists independently.

Question 38Federal Controlled Substances Act (schedules, registration, ordering, records, security)

Under federal regulation, a registrant may not allow a person to have access to controlled substances if that person:

  1. Previously worked for a competing pharmacy
  2. Was convicted of a misdemeanor traffic offense five years ago
  3. Has had a DEA registration application denied for cause Correct answer.
  4. Is younger than twenty-one years of age

Explanation

A registrant may not employ anyone with access to controlled substances who has been convicted of a felony offense relating to controlled substances or who has had a DEA registration application denied or surrendered for cause. The registrant is expected to screen employees for these disqualifications.

Question 39Federal Controlled Substances Act (schedules, registration, ordering, records, security)

Federal rules require controlled substances in Schedules II through V at a pharmacy to be stored:

  1. In a securely locked, substantially constructed cabinet Correct answer.
  2. In a locked room that only the pharmacist-in-charge may enter
  3. On open shelves behind the dispensing counter
  4. In a floor safe rated for fire resistance

Explanation

Schedule II through V stock must be kept in a securely locked, substantially constructed cabinet, or dispersed through the stock of noncontrolled substances so that a common source of loss is not created. The chosen method must deter and detect diversion.

Question 40Federal Controlled Substances Act (schedules, registration, ordering, records, security)

How must a pharmacy maintain its records of Schedule II receipts and disbursements?

  1. They may be filed with invoices for noncontrolled stock
  2. They must be kept separately from all other records Correct answer.
  3. They must be kept at the pharmacist-in-charge's residence
  4. They may be discarded once the biennial inventory is signed

Explanation

Records of Schedule II substances must be maintained separately from all other records of the registrant. Records for Schedules III through V need only be readily retrievable from the ordinary business records.

Question 41Federal Controlled Substances Act (schedules, registration, ordering, records, security)

When a substance is placed in a schedule under the Controlled Substances Act, which factor is part of the required analysis?

  1. The drug's current retail price at chain pharmacies
  2. The drug's potential for psychic or physical dependence Correct answer.
  3. The number of prescriptions dispensed nationwide last year
  4. The manufacturer's share of the national market for the drug

Explanation

The statutory factors include the drug's actual or potential abuse potential, its pharmacological effect, the state of scientific knowledge, its history and pattern of abuse, the risk to public health, and its psychic or physiologic dependence liability. Commercial and pricing considerations play no part in scheduling.

Question 42Federal Controlled Substances Act (schedules, registration, ordering, records, security)

DEA is evaluating a new pharmacy's application for registration. Which consideration is part of the public interest determination?

  1. The number of hours the store plans to be open each week
  2. The distance to the nearest competing pharmacy
  3. The applicant's record of compliance with drug laws Correct answer.
  4. The applicant's projected annual sales volume

Explanation

The public interest factors include compliance with applicable federal, state, and local laws relating to controlled substances, the applicant's experience, any conviction record for controlled substance offenses, and past experience with controlled substances. Business volume and convenience considerations are not part of the test.

Question 43Federal Controlled Substances Act (schedules, registration, ordering, records, security)

A pharmacy wants to place Schedule II orders electronically instead of on paper. What must the pharmacy obtain?

  1. A notarized waiver from DEA permitting electronic signatures
  2. A scanned copy of a signed paper Form 222 emailed to the supplier
  3. A state board of pharmacy letter authorizing electronic orders
  4. A CSOS digital certificate from DEA and compliant software Correct answer.

Explanation

Electronic orders for Schedule I and II substances must go through DEA's Controlled Substance Ordering System, using a CSOS digital certificate issued to each individual who signs orders. That digital signature is legally equivalent to a handwritten signature on Form 222.

Question 44Federal Controlled Substances Act (schedules, registration, ordering, records, security)

Which information must a biennial inventory of controlled substances include for each item?

  1. The total number of controlled substance units on hand
  2. The name, strength, and quantity of the substance Correct answer.
  3. Only Schedule II substances, itemized by lot number
  4. The wholesale cost and expiration date of each product

Explanation

The inventory must list each controlled substance by name, strength, and dosage unit or volume together with the quantity on hand, and must state whether it was taken at the opening or close of business. Each page must be signed and dated by the person who took the inventory.

Question 45New Jersey Pharmacy Practice Act and Board of Pharmacy regulations (licensure, registration, personnel, facilities)

The New Jersey Board of Pharmacy carries out its licensing and regulatory functions within which entity?

  1. The Department of Banking and Insurance
  2. The Division of Consumer Affairs Correct answer.
  3. The Department of Health
  4. The Division of Criminal Justice

Explanation

The Board of Pharmacy is a professional licensing board created under the New Jersey Pharmacy Practice Act and is located in the Division of Consumer Affairs within the Department of Law and Public Safety. The Division supplies the Board's administrative and investigative support, while the Board itself adopts regulations and adjudicates licensure matters.

Question 46New Jersey Pharmacy Practice Act and Board of Pharmacy regulations (licensure, registration, personnel, facilities)

Before a new community pharmacy may open in New Jersey, the owner must obtain which of the following?

  1. A municipal mercantile license from the town clerk
  2. A pharmacy registration issued by the Board of Pharmacy Correct answer.
  3. A certificate of need from the State Health Department
  4. A county health department operating permit for the premises

Explanation

No person may operate a pharmacy in New Jersey unless the pharmacy is registered with the Board of Pharmacy. The registration is issued for a specific location and owner, and operating without it is a violation of the Pharmacy Practice Act.

Question 47New Jersey Pharmacy Practice Act and Board of Pharmacy regulations (licensure, registration, personnel, facilities)

In New Jersey, which person is responsible for a pharmacy's day-to-day compliance with Board regulations?

  1. The pharmacist-in-charge, a New Jersey licensee Correct answer.
  2. The district manager responsible for the region
  3. The senior certified technician working that day
  4. The owner of the business, whether or not licensed

Explanation

Every registered pharmacy must have a designated pharmacist-in-charge who holds a current New Jersey pharmacist license. That pharmacist is accountable for the pharmacy's compliance with the Pharmacy Practice Act and Board regulations, including recordkeeping, security, and supervision of personnel.

Question 48New Jersey Pharmacy Practice Act and Board of Pharmacy regulations (licensure, registration, personnel, facilities)

Which statement about pharmacy technicians in New Jersey is correct?

  1. They are licensed by the Board as pharmacy interns
  2. They must pass a Board-administered competency examination
  3. They must be registered with the Board before beginning employment
  4. They work under pharmacist supervision without Board licensure Correct answer.

Explanation

New Jersey does not license, register, or certify pharmacy technicians; the Board regulates technicians only indirectly by requiring that they be supervised by a licensed pharmacist. Interns are separately registered, but occupying a technician role does not require Board registration.

Question 49New Jersey Pharmacy Practice Act and Board of Pharmacy regulations (licensure, registration, personnel, facilities)

A New Jersey pharmacy that is open to the public must have a licensed pharmacist present:

  1. Only during the hours specified in its registration
  2. Only while controlled substances are being dispensed
  3. For a minimum of four hours each business day
  4. At all times during which the pharmacy is open Correct answer.

Explanation

A pharmacy may not be open for the practice of pharmacy unless a licensed pharmacist is on duty. When no pharmacist is present, the prescription department must be closed and secured, and unlicensed personnel may not provide pharmacy services.

Question 50New Jersey Pharmacy Practice Act and Board of Pharmacy regulations (licensure, registration, personnel, facilities)

What must a New Jersey pharmacy do with medication that a patient has returned?

  1. Dispense it if the expiration date has not passed
  2. Never return it to dispensing stock Correct answer.
  3. Return it to stock if the original safety seal is intact
  4. Reshelve it after a pharmacist inspects the packaging

Explanation

Once a prescription drug has left the pharmacy's control, it cannot be returned to dispensing stock or resold, because the pharmacy cannot assure the product's storage conditions and integrity. Returned medications must be quarantined and disposed of according to Board and environmental requirements.