Regulatory Framework and Oversight of Pharmacy Practice
Two sovereigns, one prescription
Pharmacy regulation is a layered system. States exercise police power to protect public health, so the Pennsylvania Board of Pharmacy - housed in the Department of State's Bureau of Professional and Occupational Affairs - defines the practice of pharmacy, sets licensure and operational standards through 49 Pa. Code Ch. 27, and disciplines licensees. Federal agencies regulate products and substances: FDA approves drugs, controls labeling and REMS, and governs manufacturing and advertising; DEA administers the Controlled Substances Act and registers every handler of controlled substances; CMS sets Conditions of Participation for hospitals and long-term care that drive formulary, drug regimen review, and consultant pharmacist duties; USP standards (795, 797, 800) reach compounding through state adoption and accreditation. When rules conflict, separate the question: a state rule cannot make federally prohibited conduct legal, but a state may impose stricter requirements. The "more restrictive rule governs" shortcut works for labeling, recordkeeping, and controlled substance security; it fails where federal law occupies the field, such as drug approval and market withdrawal.
Traps
Assuming an FDA-approved product is legal to dispense without a state license and a valid prescription; assuming DEA registration alone authorizes practice (it never does - the state license comes first); assuming another state's license travels; assuming the Board's reach ends at the pharmacy door (unprofessional conduct, impaired practice, and diversion are regulated wherever they occur); confusing FDA's authority to approve marketing with authority to decide who may prescribe or dispense.
Rule of thumb
Ask three questions in order - Is this a product question (FDA)? A controlled substance question (DEA plus state schedule)? Or a practice question (Board of Pharmacy)? Example: a pharmacist is asked to dispense a Schedule II drug written by a Delaware-licensed physician for a Pennsylvania patient. The pharmacist must first confirm the prescriber's authority to prescribe in Pennsylvania (state) and a valid DEA registration (federal); only then does any dispensing question arise.