Multiple Choice
The Kefauver-Harris Amendment of 1962 required manufacturers to provide __________________.
proof of both safety and efficacy before marketing
The ___________________ allowed for quicker introduction of lower-cost generic drugs.
Hatch-Waxman Act of 1984
The largest number of patients are in _________________ of clinical drug testing.
Phase III
The sale of exempt narcotics is limited by home many dosage units is limited by how many dosage units can be sold in any given ______________ period.
48 hour period
Drugs in DEA Schedule I have no accepted medical use
TRUE
The _____________________ requires pharmacists to dispense most prescription drugs in child proof packaging.
Poison Prevention Packaging Act of 1970
It is the responsibility of the __________________ to provide proof that a drug is safe and effective.
The Waxman-Hatch Act provided for up to ___________ year extensions of patient protection beyond the 17 years for a drug patent.
5 year
Emily's Law defines qualified pharmacy technicians in ____________.
Ohio
Exempt narcotics are in DEA Schedule III
The _____________________ provides incentives to promote research, approval, and marketing of drugs needed for the treatment of rare diseases.
Orphan Drug Act of 1983
Clinical trials involve ___________________.
testing drugs on people
Drug products that contain identical amounts of the same active ingredients in the same dosage form are _________________.
pharmaceutical equivalents
The first set of numbers in the NDC indicates _______________________.
The Manufacturer
Anabolic steroids are in DEA Schedule III
TRUE
The ___________________ requires pharmacist to offer counseling to Medicaid patients receiving prescriptions.
Omnibus Budget Reconciliation Act of 1990
An inactive substance given in place of a medication is a/an ____________.
placebo
Under the Combat Methamphetamine Epidemic Act, the pharmacy or store that sells pseudoephedrine-contain products must maintain written or electronic records of the transactions for a period of ______________.
two years
The second set of numbers in the NDC indicates _______________.
the drug name, strength, and dosage form
FALSE
The _____________________ provides regulations for the transfer of patient health information.
Health Insurance Portability and Accountability Act of 1996 (HIPPA)
The main purpose of phase II clinical drug testing is ________________________.
efficacy
Exempt narcotics can be sold by a pharmacist to persons at least ______________ years of age.
18 years of age
The third set of numbers in the NDC indicates _______________________.
the package size
Copy 2 of DEA Form 222 is eventually kept by the DEA
TRUE