Federal Statutes, Regulations, and Agency Guidance
Who regulates what
Federal law governs the drug product and the closed chain of distribution; the states govern the practice of pharmacy. Knowing which actor a statute addresses is the entire game. The FD&C Act controls approval status, adulteration (cGMP failures, contamination, insanitary handling) versus misbranding (false or misleading labeling, missing required label information, dispensing a prescription drug without a valid prescription). The CSA controls scheduled substances. The PPPA sets child-resistant packaging standards, with narrow exceptions such as a patient or prescriber request. The Prescription Drug Marketing Act governs drug samples and forbids their resale. The DSCSA requires authorized trading partners, product tracing (transaction information, history, statement), verification of suspect and illegitimate product, and proper handling of saleable returns. The CMEA restricts pseudoephedrine sales. OBRA-90 requires prospective drug utilization review and an offer to counsel for Medicaid patients. HIPAA limits uses and disclosures of protected health information.
Traps
The FDA does not license pharmacies or pharmacists and does not regulate how a prescriber chooses therapy: off-label prescribing is lawful. An FDA-approved drug is still misbranded if dispensed without a required prescription. Guidance documents and warning letters are not statutes; guidance is nonbinding. Federal obligations stack on top of state ones rather than replacing them.
Rule of thumb
Ask who the statute addresses. "May this person prescribe, dispense, or counsel?" is state board territory. "Is this product adulterated, misbranded, or properly traced?" is FDA territory. "How must this controlled substance be ordered, stored, and recorded?" is DEA territory.
Worked example
A prescriber writes for an FDA-approved drug for a use not in its labeling. The pharmacist may dispense on a valid prescription; the FDA regulates manufacturer promotion, not the prescriber's practice.