Which set of regulations dictate the appropriate standards for sterile compounding?

Which of these is always true regarding Schedule II controlled substances?

The pharmacist in charge must verify and document the date received on all received CII medications.

CII medications can be ordered with a hand-written DEA 222 form or through the Controlled Substance Ordering System (CSOS). When using an electronic system to order, the DEA 222 form is not required. The pharmacist who is registered with the FDA (the pharmacist in charge) must sign and date all records for CII drugs. Controlled substances may be returned to the supplier. To destroy the medications, the pharmacy or distributor must fill out a DEA 41 form with all appropriate information about the destruction.

This law defined two specific categories for medications: prescription and over-the-counter.

Durham-Humphrey Amendment

Until the Durham-Humphrey Amendment was passed, there was no requirement that any drug be labeled for sale by prescription only. The amendment defined prescription drugs as those unsafe for self-medication and which should therefore be used only under a doctor's supervision.

Which agency regulates the dispensing of radio- pharmaceuticals?

NRC

The Nuclear Regulatory Commission (NRC) is responsible for the dispensing of radiopharmaceuticals

Which federal law introduced a ‘proof-of-efficacy’ requirement?

Kefauver Harris Amendment

The Kefauver Harris Amendment is also known as the ‘Drug Efficacy Amendment.’ It is a 1962 amendment to the Federal Food, Drug, and Cosmetic Act. It introduced requirements for drug manufacturers to provide proof of the effectiveness and safety of their drugs before they could be approved. It also required drug advertising to disclose accurate information about side effects and efficacy of treatments.

Which law resulted in clearly distinguishing an over-the-counter medication from a prescription medication?

Durham-Humphrey Act of 1950

The Durham-Humphrey Act clearly defined legend and OTC medications.

Which resource is not required to be on hand in the pharmacy?

a compounding manual

All pharmacies are required to have a list of all laws, rules, and regulations that impact the pharmacy's practice, a reference on drug interactions, the Orange Book, a reference on natural or herbal medicines, and all references that may be pertinent to meet the needs of the patients the pharmacy serves.

Laminar flow hoods must be certified every ___ months.

6

Laminar flow hoods are used to remove contaminants and provide clean air to the working area.

Which of these sets the standards for keeping pharmacy employees safe while completing tasks associated with pharmacy practice?

the Occupational Safety and Health Administration (OSHA)

The Occupational Safety and Health Administration (OSHA) has standards to protect employees who work with hazardous materials. It also outlines the proper personal protective equipment needed in various pharmacy practice settings such as compounding. HIPAA relates to confidentiality and the PPA governs the practice of pharmacy but does not explicitly cover employee safety. USP 795 focuses only on non-sterile compounding.

Which of the following is a correct DEA number for a Dr. Andrea J. Shedlock, who was Dr. Andrea Costello when she requested her DEA number before she was married?

AC1234563

The first letter of a physician’s DEA number will be A, B, F, or M. The second letter is the first letter of the physician’s last name at the time he or she applied for the DEA number. DEA numbers are required as a result of the Controlled Substances Act.

Which agency oversees the practice of pharmacy?

State BOP

The state boards of pharmacy (BOPs) oversee the practice of pharmacy in their respective states.

For how long is a DEA Form 222 valid?

60 days

The Controlled Substances Act allows a DEA Form 222 to be valid for 60 days after it is signed by the pharmacist in charge or an individual with the power of attorney.

A drug is recalled by the FDA, but the problem is unlikely to cause any adverse health reactions. What type of recall would this be?

Class III

Class I recalls are the most serious type. Class II recalls are for less serious problems, such as temporary adverse health consequences. Class III recalls are for situations in which adverse health consequences are unlikely.

Which law required that all narcotics be labeled “Warning: May Be Habit Forming”?

Food, Drug, & Cosmetic Act of 1938

This law required all narcotics to be labeled "Warning: May be habit forming"

How many refills are allowed on CIII drugs?

5

CIII drugs can have up to 5 refills and are refillable up to 6 months. Some examples of CIII drugs include Vicodin and Xanax.

When a state pharmacy law and federal pharmacy law conflict, which law should be followed?

the more strict law

In the event a state law conflicts with or contradicts a federal law, the law that is more strict is the one that should be followed.

Which set of regulations dictate the appropriate standards for sterile compounding?

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