Pharmacy federal legislation

Which USP chapter sets standards in hazardous drug handling for patients, healthcare workers, and the environment?

USP 800

Enacted in 1990, which law requires pharmacies that fill orders for Medicaid patients to obtain, record, and maintain basic patient information?

Omnibus Budget Reconciliation Act

The Orphan Drug Act was passed to promote research and development of drugs that affect which of these categories?

Rare diseases

Material Safety Data Sheets (MSDS) were mandated after which legislation passed?

Occupational Health and Safety Act

Under the Drug Supply Chain Security Act (DSCSA), pharmacies are required to maintain product tracing documentation for how long?

6 years

Which of these medicines is classified as a Shedule IV controlled substance

Ambien

Which law established the protocol that drugs could be identified and reported using the NDC?

Drug Listing Act

Which organization is responsible for accrediting and certifying healthcare organizations in the US?

TJC

Which legislation placed prescription drug advertising under FDA supervision and required drug manufacturers to register and permit inspections of manufacturing sites?

Kefauver-Harris Amendment

Which law was passed to ensure that medicines are developed in a child protected form?

Poison Prevention Packaging Act

What is the maximum number of refills allowed for Schedule III medications?

5 refills in 6 months

How long must pharmacies retain DSCSA (Drug Supply Chain Security Act) records?

6 years

Which agency enforces DSCSA (Drug Supply Chain Security Act) requirements?

FDA

Which recall class would likely involve contamination with a harmful substance?

Class I

What should a pharmacy do FIRST when notified of a medication recall?

Identify and quarantine affected stock

A medication recall due to incorrect labeling with temporary health risk is classified as:

Class II

Which DEA form is used to document the destruction of controlled substances?

DEA Form 41

Which type of pharmaceutical waste is considered acutely hazardous?

P-listed hazardous waste

Which DEA form is used to report theft or loss of controlled substances?

DEA form 106

How long must pharmacies keep controlled substance records?

2 years

Which DEA form is used to order controlled substances?

DEA form 222