Federal Law Practice 2026

Which act/amendment requires labels to contain "Caution: Federal law prohibits dispensing without a prescription"?

a. Prescription Drug User Fee Act
b. Kefauver-Harris Amendment
c. Nutrition Labeling and Education Act
d. Waxman-Hatch Amendment
e. Durham-Humphrey Amendment

Durham-Humphrey Amendment

What is the correct meaning of misbranding?

a. The manufacturer's label is false and misleading.
b. The manufacturer's label is accurate and informative.
c. The medication's strength is the same as the one stated on the label.
d. The medication's strength differs from that on the label.
e. The improper act of making unauthorized changes to a product.

The manufacturer's label is false and misleading.

What is the correct meaning of tampering?

a. The manufacturer's label is false and misleading.
b. The manufacturer's label is accurate and informative.
c. The medication's strength is the same as the one stated on the label.
d. The medication's strength differs from that on the label.
e. The improper act of making unauthorized changes to a product.

The improper act of making unauthorized changes to a product.

All sterile compounding of hazardous compounds should take place in a ____ pressure hood.

negative

A pharmacist receives a prescription for an opioid pain medication. During the verification process, the pharmacist notices that the patient has filled similar prescriptions at multiple pharmacies in the past month.

What is the pharmacist’s most appropriate course of action?

a. Contact the prescribing physician to verify the medical necessity of the prescription.
b. Fill the prescription and document the concern in the patient’s profile.
c. Fill the prescription as written and monitor the patient’s future activity.
d. Refuse to fill the prescription and inform the patient of potential misuse.
e. Report the patient to local law enforcement for suspected drug diversion.

Contact the prescribing physician to verify the medical necessity of the prescription.

A large specialty pharmacy in Pennsylvania seeks to renew its accreditation to maintain access to limited-distribution drugs and contracts with major health plans. An independent evaluation team is scheduled to assess the pharmacy’s medication safety practices, patient care standards, and organizational leadership structure. Based on the findings, the pharmacy can either retain its current accreditation status or be placed on probation pending remediation.

What agency is responsible for evaluating and accrediting this pharmacy?

a. The Agency for Healthcare Research and Quality
b. The American Society of Health-System Pharmacists
c. The Institute for Safe Medication Practices
d. The Joint Commission
e. US Food and Drug Administration

The Joint Commission

A pharmacy computer system must adhere to what pharmacy technological standards? Select all that apply.

a. Ordered medication is safe for a patient.
b. Patient information is not publicly available.
c. Prescription information is transmitted how the prescriber orders it.
d. The right patient is receiving the right medication.
e. Unauthorized users cannot hack into patient information.

Patient information is not publicly available.
Prescription information is transmitted how the prescriber orders it.
Unauthorized users cannot hack into patient information.

Name: RH

Age: 48

Weight: 105 kg

Allergies: Amoxicillin

Presenting Problem: Septic shock

A physician orders a norepinephrine (Levophed) continuous infusion to start at a rate of 3 mcg/kg/min. The norepinephrine infusion is prepared at the bedside for immediate use in this emergency setting.

According to USP <797> guidelines, what beyond-use date (BUD) should be assigned to this preparation?

a. 1 hour
b. 4 hours
c. 12 hours
d. 1 day
e. 28 days

4 hours

Under the previous USP <797>, immediate-use compounded sterile preparations (CSPs) had a ___ BUD. In the revised USP <797>, the BUD for immediate-use CSPs was extended to ___ at controlled room temperature, unless administration starts sooner. This change reflects updated evidence on sterility and practicality in emergency settings.

1-hour; 4 hours

___ applies to CSPs prepared in a segregated compounding area (SCA), assuming ISO Class 5 primary engineering control (PEC) example: ___

12 hours; single-dose containers.

___ applies to a single-dose container punctured outside ISO Class 5 conditions.

24 hours (1 day)

Multi-dose containers beyond use date is ___ after puncture, unless the manufacturer specifies otherwise.

28 days

A pharmacy identifies a discrepancy in the perpetual inventory of oxycodone tablets, showing more tablets dispensed than documented in the system.

What action must the pharmacist take first to address the discrepancy?

a. Conduct an immediate physical count of oxycodone inventory.
b. Implement stricter double-counting procedures for future dispensing.
c. Investigate staff access to controlled substance storage areas.
d. Report the discrepancy to the DEA within one business day.
e. Review recent controlled substance orders and receipts for accuracy.

Conduct an immediate physical count of oxycodone inventory.

What aspects of hazardous drug handling does USP <800> encompass? Select all that apply.

a. Administration
b. Compounding
c. Disposal
d. Manufacturing
e. Storage

Administration
Compounding
Disposal
Storage

A pharmacist is compounding a category 2 CSP to be aseptically processed. All the starting components are sterile, and no sterility testing is required for the final CSP.

What is the assigned refrigerator beyond-use date (BUD) according to USP monograph <797>?

a. 10 days
b. 60 days
c. 90 days
d. 120 days
e. 180 days

10 days

Category 2 CSPs have higher levels of compounding requirements like cleanroom and sterility. BUD is ___ in refrigeration and ___ in frozen state for CSPs that are to be aseptically processed when all the starting components are sterile and no sterility testing is required for the final CSP.

10 days; 45 days

___ is the freezer BUD for category 2 CSPs that require aseptic processing and sterility testing.

60 days

___ is the freezer BUD for category 2 CSPs that are terminally sterilized and have passed the sterility testing.

90 days

___ is the refrigerated BUD for category 3 CSPs that are terminally sterilized and have passed all the tests required for category 3 CSPs, including sterility testing.

120 days

___ is the freezer BUD for category 3 CSPs that are terminally sterilized and have passed all the tests required for category 3 CSPs, including sterility testing.

180 days

A drug is considered to be an orphan drug if it is for rare diseases or conditions that impact fewer than how many people in the U.S.?

a. 2,000
b. 100,000
c. 200,000

200,000

In the case of theft of controlled substances from a pharmacy, which form must be submitted to the DEA?

a. 106
b. 222
c. 397

106

Anabolic steroids are classified under which schedule?

a. Schedule I
b. Schedule III
c. Schedule IV

Schedule III

A pharmacy dispenses and distributes a total of 50,000 doses of controlled substances in a 12 month period. How many doses is the pharmacy able to transfer to another pharmacy without registering as a distributor?

a. 500
b. 1,000
c. 2,500

2,500

A warning stating “Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed” is required on the label for which of the following prescription types?

a. Schedule II only
b. Schedule II-IV only
c. All prescriptions

Schedule II-IV only

Which of the following circumstances would NOT be considered "adulteration" under the FDCA?

a. The product is packaged under unsanitary conditions
b. The company's manufacturing processes do not conform to GMP
c. The product is packaged in a way that does not conform to the requirements of the Poison Prevention Act

The product is packaged in a way that does not conform to the requirements of the Poison Prevention Act

While employed as a hospital pharmacy intern, you routinely repackage commercially available prescription drugs into USP-quality unit-dose containers.

On January 1, 2026, you repackage Sillycillin 200mg that carries an expiration date on the container of January 2, 2028. According to FDA recommendations, which expiration date should you place on the unit-dose packages?

a. January 2, 2028
b. January 1, 2027
c. January 31, 2026

January 1, 2027

Which of the following situations may require a pharmacy to register with the FDA, be subject to FDA inspections, and comply with CGMP?

a. a hospital pharmacy that repackages pills from bulk bottles into unit-dose packaging for that hospital's inpatients
b. a community pharmacy that compounds multiple units of a solution in anticipation of routine prescription utilization at that pharmacy
c. an Ohio community pharmacy that compounds bulk quantities of nebulizer solution and distributes the solution to pharmacies in Michigan

an Ohio community pharmacy that compounds bulk quantities of nebulizer solution and distributes the solution to pharmacies in Michigan

According to the Prescription Drug marketing Act of 1987, no person may sell, purchase, or trade:

a. prescription drug samples
b. OTC drug samples
c. repackaged prescription products

prescription drug samples