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NH MPJE Exam Questions And Answers
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Licensing of Manufacturers and Wholesalers Required. - answer✔Such license shall expire biennially on
June 30 of every even-numbered year. An application together with a reasonable fee as established by
the board shall be filed biennially by midnight on June 30 of every even-numbered year.
No license shall be granted to any person who has within 5 years been convicted of a violation of any
law of the United States, or of any state, relating to drugs, as defined in this chapter or RSA 318-B, or to
any person who is a drug-dependent person.
Notify the board of any name or address change within 30 days
A new license shall be required for - answer✔a change of ownership of an established manufacturer,
wholesaler, distributor, reverse distributor, or broker to a successor business entity which results in a
change in the controlling interest in the manufacturer, wholesaler, distributor, reverse distributor, or
broker.
Licensing of Limited Retail Drug Distributors - answer✔Such license shall expire biennially on June 30 of
each odd-numbered year. An application together with a reasonable fee as established by the board
shall be filed biennially by midnight June 15 of every odd-numbered year
Licensure of Research Organizations. - answer✔Such license shall expire biennially on June 30 of each
odd-numbered year. An application together with a reasonable fee as established by the board shall be
filed biennially by June 15 of every odd-numbered year.
Inventories and disposal transactions shall be maintained for 2 years and made available for inspection
by the board's inspectors within a period of 72 hours from notice.
Prior Authorization meds that are necessary - answer✔give 72 hrs supply only (3 days)
Licensure of Drug or Device Distribution Agents - answer✔a) A drug or device distribution agent shall
include virtual manufacturers, virtual wholesaler distributors, jobbers or brokers (including
sales/marketing offices), and third-party logistics companies, and any other agent involved in the
handling or distribution of prescription drugs, medical gases, or prescription medical devices or
equipment in the supply chain that affects the pedigree of the products.
(b) "Broker or jobber" is any party that mediates between a buyer and a seller for the sale or shipment
of prescription drugs, gases, equipment, or devices.(c) "Pedigree" is a document or an electronic file
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containing information that records each distribution of any given prescription drug, medical gas, or
prescription medical device or equipment.(d) "Third-party logistics provider" is a person that contracts
with a wholesale distributor or a manufacturer to provide or coordinate warehousing, wholesale
distribution, or other services on behalf of a manufacturer, but does not take title to the prescription
drug, gas, device, or equipment.(e) "Virtual manufacturer" is anyone that owns the NDA or ANDA for a
prescription drug, gas, device, or equipment that contracts with others for the actual manufacturing.(f)
"Virtual wholesale distributor" is anyone engaged in wholesale distribution of prescription drugs, gases,
devices, or equipment.
hypodermic syringe - answer✔18 years and above to purchase needles
hypodermic syringe prescription is valid for - answer✔one year
Fines and Imprisonment; - answer✔any person violating the provisions of this chapter, except as
otherwise provided, shall be guilty of a misdemeanor if a natural person, or guilty of a felony if any other
person.II. In addition to the penalties under paragraph I, the board may impose a civil penalty not to
exceed $5,000 per violation upon any person who willfully or repeatedly violates any provision of this
chapter.III. For any order issued in resolution of a disciplinary proceeding before the board, the board
may require that any licensee, permittee, registrant, or certificate holder found guilty of a charge
involving any drug law or rule to pay to the board a sum not to exceed the reasonable cost of
investigation and prosecution of the proceeding. The sum shall not exceed $5,000. The costs to be
assessed shall be fixed by the board and any sums recovered shall be paid to the state treasurer for
deposit in the office of professional licensure and certification fund.
Unused prescription drugs and medical devices may not be resold, but - answer✔the facility or service
redispensing such drug or device may charge a handling fee for the service not to exceed $15.
Pharmacy Rights During Audit - answer✔I. To have at least 7 days' advance notice of the initial on-site
audit for each audit cycle. A pharmacy that requests an additional 7 days prior to the commencement of
an audit shall be granted 7 additional days.
If an on-site audit is conducted for a reason other than an identified problem, the audit shall be limited
to no more than 250 selected prescriptions and the third party plan or audit company must provide a
masked list of prescriptions to the pharmacy to assist in preparation. The list is considered masked if the
last 2 numbers of the prescription are marked with an "X." This procedure allows the pharmacy to pull
the book the audited prescription is in, however it does not allow the pharmacy to pull the specific
prescription audited. Additionally, all of the invoices for actual dispensed prescriptions, with prices
redacted, may be obtained from the pharmacy's wholesaler or distributor upon approval from the
pharmacy.VI-a. To have the same number of days to respond to a claim in an audit that have passed
since the origination of the claim.VII. To be subject to no more than 2 audits in one calendar year, unless
fraud or misrepresentation is reasonably suspected.VIII. Except for cases of Food and Drug
Administration regulation or drug manufacturer safety programs, to be free of recoupments based on
any of the following unless defined within the billing requirements set forth in the pharmacy provider
manual:(a) Documentation requirements in addition to or exceeding requirements for creating or
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maintaining documentation prescribed by the pharmacy board or by the provider manual or contract.(b)
A requirement that a pharmacy or pharmacist perform a professional duty in addition to or exceeding
professional duties prescribed by the board.IX. To be audited under the same standards and parameters
as other similarly sit
Mandatory Appeals Process - answer✔I. Each entity that conducts an audit of a pharmacy shall establish
an appeals process under which a pharmacy may appeal within 30 days after the report an unfavorable
audit report to the entity.II. If, following the appeal, the entity finds that an unfavorable audit report or
any portion of the unfavorable audit report is unsubstantiated, the entity shall dismiss the
unsubstantiated portion of the audit report without any further proceedings unless outlined in the
contract.III. Each entity conducting an audit shall provide a copy, if required under contractual terms, of
the audit findings to the plan sponsor after completion of any appeals process.IV. If any portion of an
unfavorable audit report is not dismissed within 30 days after an appeal is made under paragraph I, the
pharmacy may request a hearing from the insurance department pursuant to RSA 400-A:17.
Audit Information and Reports - answer✔An audit report shall be delivered to the pharmacy within 75
days, unless otherwise agreed to, after the conclusion of the audit. A pharmacy shall be allowed at least
30 days, unless otherwise agreed to, following receipt of the audit report to appeal any discrepancy
found in the audit. A final audit report shall be delivered to the pharmacy within 90 days, unless
otherwise agreed to, after receipt of the appeal. A charge-back, recoupment, or other penalty may not
be assessed until the appeal process has been exhausted and the final report issued except as specified
in RSA 318:64. Except as provided by state or federal law or contract, audit information may not be
shared. Auditors may have access only to previous audit reports on a particular pharmacy conducted by
that same entity.
Notice Required - answer✔I. A prescription drug manufacturer shall notify the department in writing if it
is introducing a new prescription drug to market at a wholesale acquisition cost that exceeds the
threshold set for a specialty drug under the Medicare Part D program. The manufacturer shall provide
the written notice within 3 calendar days following the release of the drug in the commercial market. A
manufacturer may make the notification pending approval by the United States Food and Drug
Administration (FDA) if commercial availability is expected within 3 calendar days following the
approval.II. No later than 30 calendar days following notification required under paragraph I, the
manufacturer shall provide the following information to the department in a format that the
department prescribes:(a) A description of the marketing and pricing plans used in the launch of the
new drug in the United States and internationally.(b) The estimated volume of patients who may be
prescribed the drug.(c) Whether the drug was granted breakthrough therapy designation or priority
review by the FDA prior to final approval.(d) The date and price of acquisition if the drug was not
developed by the manufacturer.III. The manufacturer may limit the information required under
paragraph II to that which is otherwise in the public domain or publicly available.IV. The department
shall publish on its Internet website, at least quarterly, the information reported to it under this section.
The information shall be published in a manner that identifies the information that is disclosed on a per-
drug basis and shall not be aggregated in a manner that would not allow identification of the drug.V. The
