PTCB Federal Requirements

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

• Pharmacist

• Nurse

• Pharmacy Technician

• Physician

Answer explanation

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

Explain Schedule I substances

• Have accepted medical use in the US and is not addictive

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

• Are legal substances with low potential for abuse

• Are substances that can be prescribed by doctors

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.

Which Act designates 5 controlled drug classes and specifies the type of medications that are in each?

• Prescription drug marketing act

• Controlled substance act

• Federal food, drug and cosmetic act

• Poison prevention packaging act

How long do all records need to be maintained and readily available?

• 1 year

• 2 years

• 3 years

• 5 years

What is a Class II Recall?

• Recall of an item that is slightly less serious to a Class I and unlikely to cause serious concerns.

• Recall of an item that poses a significant risk of serious health problems or death.

• Recall of an item that is not likely to cause any adverse health consequences.

• Recall of an item that is voluntarily removed from the market by the manufacturer.

In terms of severity and level of danger of a manufactured drug with defects, what is the order of reporting from greatest harm to least harm?

• Class II, Class III, and Class I

• Class I, Class II, and Class III

• Class III, Class II, and Class I

• Class IV, Class III, Class II, and Class I

While working in a compounding pharmacy, you notice that a bottle of disinfectant is leaking and spreading all over the floor. When you report to the pharmacist, he asks you to take care of it. What would be the first step in appropriately cleaning the spill?

• consult the MSDS for handling chemicals

• use a mop to clean the spill

• ignore the spill and continue working

• call for a janitor to handle it

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

• Controlled Substance Act

• Drug Enforcement Administration Act

• Substance Abuse Prevention Act

• Addictive Substance Regulation Act

DEA Takeback program

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

• Dispose of medications in household trash.

• Return medications to the pharmacy where they were purchased.

• Flush medications down the toilet.

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.

What is the STEPS program?

• System for Thalidomide Education and Prescribing Safety

• Standardized Treatment Evaluation and Prescription System

• Safety Training for Emergency Procedures and Services

• Systematic Evaluation of Therapeutic Practices and Standards

Answer explanation

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