Regulatory Compliance Flashcards

Which DEA form is used to report the theft or significant loss of controlled substances from a pharmacy?

Answer: DEA Form 106

DEA Form 106 must be completed and submitted to report theft or significant loss of controlled substances.

The Risk Evaluation and Mitigation Strategy (REMS) program is administered by which agency?

Answer: FDA

The FDA administers REMS programs to ensure benefits of certain drugs outweigh their risks.

Under the Combat Methamphetamine Epidemic Act (CMEA), what is the daily sales limit for pseudoephedrine products per purchaser?

Answer: 3.6 grams

CMEA limits daily pseudoephedrine sales to 3.6 grams per purchaser and 9 grams per 30-day period.

A nursing facility resident's medication regimen is reviewed and a potentially inappropriate medication is identified per the Beers Criteria. This review is BEST classified as:

Answer: Retrospective drug utilization review

Monthly medication regimen reviews in LTC are retrospective DUR, evaluating medications already dispensed.

Which federal law established the Prescription Drug Monitoring Program (PDMP) grant funding to states?

Answer: Harold Rogers Prescription Drug Monitoring Program

The Harold Rogers PDMP provides federal grant funding to states to establish and enhance prescription drug monitoring programs.

Which CMS condition of participation requires a hospital pharmacy to have a pharmacist available or on call at all times?

Answer: 482.25 - Pharmaceutical Services

42 CFR 482.25 specifies that hospital pharmaceutical services must ensure a pharmacist is available or on call 24/7.

Under the Drug Supply Chain Security Act (DSCSA), pharmacies must be able to trace prescription drug products for how many years?

Answer: 3 years

DSCSA requires pharmacies to maintain transaction documentation and tracing records for 3 years.