Labeling and Packaging Requirements

Question 1

Board of pharmacy labeling requirements

Answer 1

state boards of pharmacy specify the requirements for the content of prescription labels

Question 2

poison prevention packaging act of 1970

Answer 2

this law required the use of child-resistant packaging for prescription drugs, over-the-counter (OTC) drugs, household chemicals, and other hazardous materials that could be considered dangerous for children

Question 3

Label components

Answer 3

• name and address of the dispenser or pharmacy
• telephone number of the pharmacy
• prescription number
• current date of its filling or refilling
• name of the prescriber
• name of the patient
• directions for use, including precautions, if any, as indicated on the prescription
• drug name and strength and quantity; if generic, the name of the manufacturer
• the phrase “use by” followed by the product’s use by date, if dispensed in any packaging other than the manufacturer’s original packaging
• all auxiliary labeling as recommended by the manufacturer and/or as deemed appropriate in the professional judgement of the dispensing pharmacist
• initials or name of the dispensing pharmacist

Question 4

some of the main products that are exempted from the PPPA include the following:

Answer 4

• powdered unflavored aspirin and effervescent aspirin
• effervescent acetaminophen
• sublingual nitroglycerin
• oral contraceptives
• hormone replacement therapy
• powdered iron preparations