PTCB Federal Requirements

Front

What is the STEPS program?

Back

System for Thalidomide Education and Prescribing Safety

Answer explanation

Mandatory counseling, pregnancy testing and registration are required before patients can receive their first prescription.

Front

Was enacted in 1970 by the US Congress to regulate manufacture, sale and prescribing of addictive substances

Back

Controlled Substance Act

Front

Who has the authority to fill out a DEA 222 form?

Back

Pharmacist

Answer explanation

Can be filled out electronically or on paper. Must be stored and easily accessible during an inspection. Retain for 2 years.

Front

Who regulates the proper disposal of pharmaceutical waste?

Back

Environmental Protection Agency

Answer explanation

EPA under the guidelines set forth by the Resource Conservation and Recovery Act

Front

What is reverse distribution?

Back

When controlled substances expire and are transferred to the distributor to determine if a credit can be given.

Answer explanation

Pharmacies can dispose of unused or expired controlled substances by using a reverse distributor registered with the DEA.

Front

DEA Takeback program

Back

Drop off unused medications to the police department. Controlled substances only.

Answer explanation

This program is a national event where pharmacies, community partners, and law enforcement agencies support collection sites. Used to return expired or unused medications for proper disposal. These items are picked up by local DEA representatives.

Front

What is a material safety data sheet (MSDS)?

Back

Contain info about chemicals, compounds, including what to do if there's an exposure or spill.

Front

What is the Drug Enforcement Agency?

Back

Implement laws around drug use, abuse, and fight drug trafficking

Front

Explain Schedule I substances

Back

Have no accepted medical use in the US and is highly addictive

Answer explanation

Schedule I substances do not have accepted medical use in the US but can be used by researchers who've obtained special permission by the FDA.

Front

What is MedWatch?

Back

Allows healthcare professionals and consumers to report adverse reactions.

Answer explanation

MedWatch is the FDA program that allows healthcare professionals and consumers to report adverse reactions to and safety concerns regarding products regulated by the FDA. These products include: medications, medical devices, supplies and dietary supplements.