Federal Regulations of Dispensing: Dispensing Slides Exam 1

Question 1

Durham-Humphrey Amendment

Answer 1

• Establishes criteria for distinguishing prescription drugs from OTC drugs
• Legally establishes oral prescriptions and refills
• Although the amendment did not contemplate electronic prescriptions, other federal and state laws permit them.
• Specifies the minimum information that a dispensed Rx label must contain
• Expiration or beyond-use dating on dispensed Rx label required pursuant to state laws
• made it okay to have an rx label that is different from the manufacturer label

Question 2

How can Rx drugs be switched to OTC drugs?

Answer 2

– SNDA: product-specific switch
– Petition: product-specific switch
– Adding or amending an OTC drug monograph; affects all products in the class

Question 3

Third Class of Drugs

Answer 3

• Behind-the-Counter and Nonprescription Under Conditions of Safe Use
• Refers to creating a class of drugs that can only be sold from the pharmacy department

Question 4

Conscientious Objection

Answer 4

• Refers to whether a pharmacist has a right to refuse to dispense prescriptions when a moral or religious objection exists
• pharmacist cannot obstruct a patient’s legal right to receive medications

Question 5

Off-label Indications

Answer 5

• legal under FDCA

- requires professional evaluation of risk vs. benefit

Question 6

Compounding Quality Act

Answer 6

• Passed as part of Drug Quality and Security Act
• Reinstated § 503A, minus unconstitutional provisions, thus stripped FDA of its perceived new drug authority
• Allows compounders of sterile products to voluntarily register as “outsourcing facilities.” Products exempt from misbranding provisions.

Question 7

Orange Book

Answer 7

• Evaluates pharmaceutically equivalent products on the basis of bioequivalence
• Pharmacists must comply with state law when substituting and exercise professional judgment substituting B-rated products.

Question 8

Pharmaceutical equivalence

Answer 8

products contain same active ingredients and are identical in strength and dosage form

Question 9

Bioequivalent pharmaceutical equivalents

Answer 9

enerally presumed therapeutically equivalent— having same clinical safety and efficacy

Question 10

Prescription Drug Marketing Act

Answer 10

• Requires state licensing of wholesalers
• Bans reimportation of Rx drugs except by manufacturer
• Bans sale, trade, or purchase of Rx drug samples
• Mandates requirements for Rx drug samples
• Prohibits resale of Rx drugs purchased by hospitals or healthcare facilities
• Pedigree requirement established for secondary wholesalers

Question 11

Poison Prevention Packaging Act

Answer 11

• Administered by the Consumer Product Safety Commission

* The law establishes the standards for childresistant containers.

Question 12

What are exemptions to the Poison Prevention Packaging Act?

Answer 12

– Prescriber requests
– Patient requests
– Institutionalized patients
– Certain drug products such as SL nitroglycerin and SL and chewable isosorbide dinitrate
– For manufacturer: May market one size in noncompliant package with appropriate statement