1 Foundations of Federal Pharmacy Compliance Free Online FlashCards

What does the FDA regulate in pharmacy?

The FDA regulates drugs and biologics, including their approval, labeling, manufacturing quality, and safety.

What is the DEA’s role under the CSA?

The DEA administers and enforces much of the Controlled Substances Act (CSA), including registration and controls on handling and dispensing controlled substances.

What factors help determine CSA schedules?

The CSA schedules controlled substances based in part on accepted medical use and abuse potential.

When is a pharmacy generally covered by HIPAA?

A pharmacy is generally a HIPAA-covered health care provider if it conducts certain covered transactions electronically.

What is CMS’s role in pharmacy compliance?

CMS administers Medicare and Medicaid and sets requirements for participating health plans and providers.

What areas can Medicare Part D requirements affect?

Medicare Part D requirements can affect prescription coverage, pharmacy networks, claims, and certain electronic-prescribing rules.

What are key state roles in pharmacy regulation?

State legislatures and boards of pharmacy generally license pharmacists and pharmacies and regulate day-to-day professional practice.

Does federal law automatically displace every state pharmacy rule?

The Supremacy Clause makes valid federal law supreme when it conflicts with state law, but it does not automatically displace every state rule on the same subject.

When does the CSA displace a state requirement?

The CSA preserves state authority unless a state requirement creates a “positive conflict” that prevents federal and state requirements from consistently standing together.

Can state pharmacy rules add compatible controls?

A state may impose additional controls, such as stricter limits or procedures, when they can coexist with federal requirements.

Does the stricter rule always control?

No. The stricter rule is not automatically controlling; express preemption, an actual conflict, or a statute’s specific terms may determine the outcome.

Can state law authorize conduct prohibited by federal law?

State law cannot authorize conduct that federal law prohibits.