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Utah MPJE Edition. All questions and 5-Star Rated Correct Answers. Graded A+
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Utah MPJE 2024-2025 Edition. Allquestions and 5-Star Rated Correct
Answers. Graded A+
"Closed Door" Pharmacy - ANSPharmacies that sell quantities of SLCP to institutions,
including long term care facilities, jails and other institutional-type settings for non-
patient specific use
"For Cause" - ANSSurrendering a registration in lieu of, or as a consequence of, any
federal or state administrative, civil or criminal action resulting from an investigation of
the individual's handling of CS
10th Amendment - ANSThe powers not delegated to the US by the Constitution, nor
prohibited by it to the States, are reserved to the States respectively, or to the people.
4 types of claims that can be made by suppliers of dietary supplements -
ANS1)Statements that the product will benefit a classic nutritional deficiency disease, so
long as it disclosed the prevalence of the disease in the US
2)Statements that DESCRIBE the role of the dietary supplement in AFFECTING the
structure of function of the human body
3) Statements that CHARACTERIZE the documented mechanism by which a nutrient or
dietary supplement acts to MAINTAIN structure and function
4) Statements DESCRIBING general well-being from consumption of the nutrient or
dietary ingredient
Abbreviated New Drug Application (ANDA) - ANSA procedure for obtaining FDA pre-
marketing approval of a (generic) copy of a drug PREVIOUSLY approved by the FDA.
-Applies to ALL approved drug products upon EXPIRY of patent and/or NDA-exclusivity
period
-ANDA does NOT require submission of safety and efficacy data
-ANDA DOES REQUIRE BIOEQUIVALENCE studies for most dosage forms
-Usually requires 6-8 months for approval
-Also applies to approval for copies of mongraphed antibiotic drugs (effective May 23,
1985)
Access to Database information (CS database) - ANS-Division (DOPL) investigation
staff
-Division and Health Dept personnel authorized to analyze CS Rx
-Practitioner licensed to PRESCRIBE CS
--MAY designate up to THREE employees to also have access
,--Each employee registers and receives own password
-Rph licensed to dispense CS
--CPhT or INTERN as designated by PIC
-Federal, state, local law enforcement authorities
-Mental health therapist
-Individual who is the recipient of a CS prescription
--Access MUST be authorized by Division
Act of Commission - ANSDoing something a reasonable and prudent person would not
do
Act of Omission - ANSFailing to do something a reasonable person would do
Adequate information for use - ANSis meant for incorporation into the product package
insert
Administer (CS def) - ANSthe direct application of a CS, whether by injection, inhalation,
ingestion or any other means
-to the body of a patient or research subject by:
(i) a practitioner or, in the practitioner's presence, by the practitioner's authorized agent
OR
(ii) the patient or research subject at the direction and in the presence of the practitioner
Administrative - ANSState and federal regulations that govern the relationships between
govt and some regulated profession, trade or industry (e.g Food and drug law, tax law,
environmental law, securities law)
Administrative Inspection** KNOW THIS CARD - ANSAuthorized for CONTROLLED
premises:
-Places where required records are kept
-Places that licensees manufacture, possess, compound, process, sell, deliver, or
otherwise dispose of any CS
Authorized Agent has the right to:
-Inspect and copy records
-Inspect w/in reasonable limits, the controlled premises, pertinent equipment, finished
and unfinished material, containers, labels
-Inventory and stock of ANY CS and obtain samples of ANY substance
Administrative Penalties
**KNOW THIS CARD** - ANS(1) Preventing or refusing to PERMIT ANY authorized
agent of the Division to conduct an inspection
-Initial $500-$2000--- Subsequent $5,000
,(11) Dispensing an Rx drug to anyone who does NOT have a prescription form a
practitioner OR
-to anyone who is known or should be known as attempting to obtain drugs by fraud or
misrepresentation:
-Initial $500-$2000--- Subsequent $2,500- $10,000
(20) Violating Federal Controlled Substances Act or Utah CS Act or rules and
regulations adopted under either act:
-Initial $500-$2000--- Subsequent $2,500- $10,000
(29) Failure to follow USP-NF Ch 797 guidelines:
-Initial $500-$2000--- Subsequent $2,500- $10,000
(30) Failure to follow USP-NP ch 795 guidelines:
-Initial $250- $500--- Subsequent $500- $750
(28) Violating ANY ethical code provision of American Pharmaceutical Association Cod
of Ethics for Pharmacists Oct 27, 1994
-Initial $250- $500--- Subsequent $2000- $10,000
(31)Failing to comply with the continuing education requirements set forth in this rule:
-Initial $100- $500--- Subsequent $500-$1000
(32) Failing to provide the Division with current mailing address within 10 DAYS
following ANY change in address
-Initial $100- $200--- Subsequent $200- $300
(33) Defaulting on student loans
-Initial $100- $200--- Subsequent: $200-$500
(38) Abandoning a pharmacy and/ or leaving drugs accessible to the public:
-Initial: $500- $2,000--- Subsequent: $2,000- $10,000
(41) Unauthorized ppl in the pharmacy:
Pharmacist Initial: $50- $100
Pharmacist Subsequent: $250- $500
Pharmacy Initial: $250- $500
Pharmacy Subsequent: $1000- $2000
(42) Failure to offer to counsel:
Pharmacy personnel initial: $500- $2500
Pharmacy personnel subsequent: $5000- $10,000
Pharmacy: $2,000 per occurrence
(45) Failure to resolve identified drug therapy mgmt problems:
Initial: $500- $2500
, Subsequent: $5000-
Adulterated Drugs - ANSPrimarily concerned with the PHYSICAL condition of drugs OR
devices and the ENVIRONMENT of their manufacture
1) Prepared, packaged or held in UNSANITARY CONDITIONS
2) MANUFACTURED NOT in CONFORMANCE with GMP
3) Are in a container composed of POISONOUS or DELETERIOUS materials that leech
4) Contains or is an UNSAFE COLOR ADDITIVE
5) VARIES from official compendia
6) Is either a new UNSAFE ANIMAL DRUG or animal FEED containing a DRUG
7) Is a Class II device WITHOUT premarket approval
8) An OTC drug NOT packaged in TAMPER-RESISTANT packaging
Affidavit for Renewal of Retail/Chain Pharmacy Registration - ANSCorporations that
own or operate a CHAIN of pharmacies may submit a single DEA Form-224b that
covers ALL the chain's pharmacy registrants
-This affidavit along with a list of the corporation's registrations is provided in lieu of a
separate DEA application for each pharmacy
ANDA - ANSAbbreviated New Drug Application- accelerated drug approval for generic
drugs
-approved after 1962 and patents about to expire
ANDA (for generic equivalents & new indications) - ANSGeneric Equivalents: ONLY
limited bioavailability testing required
-Standards published in the FDA ORANGE book, USP DI volume III
New indications:
-Primarily a business decision
-Legality of using licensed drugs for non-approved (non-labeled) uses
-Illegitimacy of exclusive additional use claims
Approved Prescription Drug product List - ANSListing of ALL FDA-approved drug
products (NDA or ANDA), by active ingredient(s) and trade name along with patent or
exclusivity information.
-Supplemented monthly
-Available on subscription from the US government Printing Office
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