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QUESTION TO FEDERAL PHARMACY LAW EXAM

Within what period of time of two documented attempts of detoxification does an 18-year-old become eligible for narcotic maintenance treatment?

A. 1 month

B. 3 months

C. 6 months

D. 12 months

E. 18 months

D.

Please view 42 CFR 8.12 - Federal opioid treatment standards. Maintenance treatment for persons under age 18. A person under 18 years of age is required to have had two documented unsuccessful attempts at short-term medical withdrawal (detoxification) or drug-free treatment within a 12-month period to be eligible for methadone maintenance treatment.

Which act or amendment granted the FDA the authority to inspect factories?

A. Pure Food and Drug Act

B. Food, Drug, and Cosmetic Act

C. Durham-Humphrey Act

D. Food, Drug and Insecticide Administration

E. FDA

B.

The Federal Food, Drug, and Cosmetic (FDC) Act of 1938 is passed by Congress, containing new provisions:

  • Extending control to cosmetics and therapeutic devices.

  • Requiring new drugs to be shown safe before marketing-starting a new system of drug regulation.

  • Eliminating the Shirley Amendment requirement to prove intent to defraud in drug misbranding cases.

  • Providing that safe tolerances be set for unavoidable poisonous substances.

  • Authorizing standards of identity, quality, and fill-of-container for foods.

  • Authorizing factory inspections.

  • Adding the remedy of court injunctions to the previous penalties of seizures and prosecutions.

Which of the following acts or amendments was the first to regulate the transportation of adulterated or misbranded drugs in interstate commerce?

A. Pure Food and Drug Act

B. Food, Drug and Cosmetic Act

C. Food, Drug and Insecticide Administration

D. Drug Abuse Control

E. Drug Importation Act

A.

The key to this question is the word "first". The original Pure Food and Drugs Act (by Dr. Wiley) is passed by Congress on June 30, 1906 and signed by President Theodore Roosevelt. It prohibits interstate commerce in misbranded and adulterated foods, drinks and drugs.

Which of the following must be ordered using a DEA Form 222?

  1. Secobarbital Suppository

  2. Pentobarbital Injection

  3. Amobarbital Capsule

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