b. During 1981, the Food and Drug Administration (FDA) will require a patient
package insert to be dispensed with 10 additional drugs/drug classes. PPI distribution
will be required beginning in May 1981. Table 2-1 shows these 10 additional drugs/drug
classes and the month during 1981 when the distribution of their PPIs will be required.
Drug or Class
Table 2-1. Drugs or drug classes which will require PPIs during 1981.
2-21. INFORMATION REQUIRED ON PATIENT PACKAGE INSERTS
The following information is required on PPIs:
a. The Generic Name of the Drug or Drug Class.
b. Approved Indications of the Drug or Drug Class.
c. Contraindications of the Drug or Drug Class.
d. Adverse Reactions, Potential Hazards, and Clinically Significant
e. Cautions Associated with the Use of the Drug or Drug Class, which this area
includes activities or substances that should be avoided when taking the drug.
f. Information Pertinent to Expectant/Breast-Feeding Mothers in this section
focuses on established risks to the fetus, risks to the expectant mother, and the transfer
of the drug from the mother to the infant in breast milk.