Tag: therapeutic equivalence

The Orange Book: How Therapeutic Equivalence Guides Generic Drug Substitution

The Orange Book: How Therapeutic Equivalence Guides Generic Drug Substitution

The Orange Book is the FDA's official guide to therapeutic equivalence, determining which generic drugs can safely replace brand-name medications. It saves billions annually and is used daily by pharmacists, insurers, and regulators.

Documentation Requirements for Recording Generic Substitution Decisions in Pharmacy Practice

Documentation Requirements for Recording Generic Substitution Decisions in Pharmacy Practice

Pharmacists must document every generic drug substitution to ensure patient safety and legal compliance. Rules vary by state, but core requirements include brand name, generic name, manufacturer, lot number, and expiration date. Proper documentation prevents errors, supports audits, and saves lives.