FREE Multistate Pharmacy Jurisprudence Federal Questions and Answers
Which legislation stipulated that new medications must first be deemed secure and efficient for the intended use?
According to the Kefauver-Harris Amendment of 1962, new medications had to be demonstrated to be both safe and effective for the intended application. Additionally, it established reasonable manufacturing procedures for producing pharmaceuticals and granted the FDA control over the promotion of prescription medications.
Which schedule does anabolic steroid classification fall under?
A restricted drug under Schedule III is anabolic steroids.
Advertising for over-the-counter (OTC) medications is controlled by:
The Federal Trade Commission regulates OTC medicine advertising (FTC). The Food and Medicine Administration oversees prescription drug advertising (FDA).
A pharmacy dispenses and distributes 50,000 doses of restricted drugs in a calendar year. The pharmacy can transfer how many doses to another pharmacy before signing up as a distributor.
According to the 5% rule, a pharmacy is exempt from registering as a distributor with the DEA if the total amount of controlled drugs distributed throughout 12 months does not exceed 5% of the total amount of controlled substances prescribed and distributed during that time.
If included in a product, which of the following substances must have particular labeling requirements?
Federal rules provide particular labeling requirements on several components, including FD&C Yellow No. 5, aspartame, wintergreen oil, mineral oil, salicylates, sulfites, ipecac syrup, and alcohol. The product must warn about the possibility of an allergic response in some sensitive individuals in the "precautions" section and declare the presence of FD&C Yellow No. 5.
When a patient is brought to the hospital, she cannot identify the prescriptions she takes at home. To get a list of prescriptions, the hospital pharmacist calls the patient's outpatient pharmacy. Which statement is accurate?
HIPAA permits the use of protected health information (PHI) for treatment purposes. This information can be given to anyone involved in the patient’s care, and does not require written or verbal consent.