STUDY GUIDE 2026 FULL QUESTIONS AND
SOLUTIONS GRADED A+
• C-III through V can only be transferred once UNLESS _____.
Answer: different pharmacies share a real-time online database
• Institutional DEA number.
Answer: DEA number assigned to an institution that covers multiple
providers Practitioners can sometimes use an institution's DEA number
instead of registering for their own DEA number.
• Investigational new drug application.
Answer: An application that must be submitted to the FDA before a drug
can be studied using clinical trials
• PHI for a divorce hearing is (allowed/not allowed).
Answer: Not Allowed
• How often does the FDA inspect compounders.
Answer: At least once every 2 years
• Can pharmacy containers be reused?.
Answer: No Prohibited under PPPA of 1970
• Pre-'38 Drug.
Answer: Drug on the market before 1938 and still on the market in 1962,
which was considered safe and effective for use based on its longevity
• Generic drugs are approved by filing a ____ or ____.
Answer: Abbreviated New Drug Application (ANDA) OR 505(b)(2)
application
• Schedule III drugs.
Answer: Potential for abuse less than schedule I and II drugs Currently
accepted medical use in the US Abuse may lead to moderate or low physical
, dependence or high psychological dependence Examples: anabolic steroids,
buprenorphine, ketamine
• Minimum age in Kansas to become a licensed pharmacist.
Answer: 18 years
• Regulation.
Answer: A rule having the force of law issued by an administrative agency
Goes through a review process and can be commented on by the public
Federal - CFR Kansas - KAR
• How long does a pharmacisdt have to notify the board of a change of
address or email address?.
Answer: within 30 days of change.
• Streamlined generic approvals (established ANDA and 505(b)(2)) and
granted protection to drug innovators.
Answer: Hatch-Waxman Act of 1984
• When should a prospective DUR be completed following a Medicaid patient
dropping off a new prescription?.
Answer: Before dispensing the prescription
• AB rating system.
Answer: First letter gives therapeutic equivalence; second letter provides
additional bioequivalence information or dosage form information A:
A-rated products are therapeutically equivalent to the RLD and can be
substituted B: B-rated products are not therapeutically equivalent to the
RLD and cannot be substituted
• All ____ and ____ have NDC numbers.
Answer: Rx AND OTC
• Federal Antitampering Act requirements.
Answer: Required for products available to a patient on a retail shelf Must
have one or more indicators or barriers of entry
• Compounded in an ISO 5 PEC in an SCA category?.
, Answer: Category 1
• What is labeling?.
Answer: Labeling is all labels and written, printed, or graphic material on
the container, containing wrapper, or accompanying the product This
incluides a label, PPI, prescribing information, med guides, etc.
• List I Chemical.
Answer: chemical specifically designated by the DEA that in addition to
legitimate uses, is used to manufacture a CS in violation of the law (often
precursors) Ex. anthranilic acid, ephedrine, ergotamine,
norpseudoephedrine, phenylacetic acid, phenylpropanolamine ,
pseudophedrine
• Abbreviated new drug application.
Answer: The application used by generic manufacturers to show proof of
bioequivalence and proof of cGMP
• Orange Book.
Answer: Therapeutic Equivalence
• Established Controlled Substance categories.
Answer: Controlled Substances Act (CSA) of 1970
• A C-II without a prescriber signature.
Answer: Return to patient to have prescriber fix
• Compounded in an ISO 5 PEC in a cleanroom with additional requirements
(stability/sterility testing) category?.
Answer: Category 3
• Must be stored separately in the pharmacy.
Answer: INDs Expired Drugs Recalled Drugs
• The package insert contains information for the _____.
Answer: healthcare provider
• All 50 states have a _____ to prevent abuse/diversion.
Answer: PDMP