Free Multistate Pharmacy Jurisprudence Federal Questions and Answers — Questions and Answers
Question 1: If included in a product, which of the following substances must have particular labeling requirements?
- FD&C Yellow No. 5 (Correct answer)
- Gelatin
- Sorbitol
- High fructose corn syrup
- Xanthan gum
Correct answer: FD&C Yellow No. 5
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.
Question 2: 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.
- 10,000 doses
- 2,500 doses (Correct answer)
- 1,000 doses
- 5,000 doses
- 500 doses
Correct answer: 2,500 doses
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.
Question 3: Advertising for over-the-counter (OTC) medications is controlled by:
- Consumer Product Safety Commission
- None of the Above
- Federal Trade Commission (Correct answer)
- Food and Drug Administration
- Drug Quality and Security Commission
Correct answer: Federal Trade Commission
The Federal Trade Commission regulates OTC medicine advertising (FTC). The Food and Medicine Administration oversees prescription drug advertising (FDA).
Question 4: Which legislation stipulated that new medications must first be deemed secure and efficient for the intended use?
- Kefauver-Harris Amendment (Correct answer)
- Durham-Humphrey Amendment
- Prescription Drug Marketing Act
- Drug Quality and Security Act
- Food, Drug, and Cosmetic Act
Correct answer: Kefauver-Harris Amendment
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.
Question 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?
- This is not a HIPAA violation because the information is being given to the hospital pharmacy for treatment purposes (Correct answer)
- This is a HIPAA violation unless the patient has given signed consent for the information to be given to the hospital pharmacy
- This is a HIPAA violation unless the patient has given verbal consent for the information to be given to the hospital pharmacy
- This is a HIPAA violation unless the patient has given written and verbal consent for the information to be given to the hospital pharmacy
- This is not a HIPAA violation because HIPAA does not apply to patients being treated in a hospital setting
Correct answer: This is not a HIPAA violation because the information is being given to the hospital pharmacy for treatment purposes
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.
Question 6: Which schedule does anabolic steroid classification fall under?
- Schedule II
- Schedule I
- Schedule IV
- Schedule III (Correct answer)
- Schedule V
Correct answer: Schedule III
A restricted drug under Schedule III is anabolic steroids.
Free Multistate Pharmacy Jurisprudence Federal Questions and Answers
If included in a product, which of the following substances must have particular labeling requirements?