Federal and Virginia Statutory and Regulatory Framework
Two layers, one answer
Every Virginia question involves at least two layers of law. Federally, the Food, Drug and Cosmetic Act governs approval status, adulteration, misbranding, labeling, and the prescription/OTC line; the Controlled Substances Act and DEA regulations (21 CFR 1300–1321) govern scheduling, registration, ordering, security, and recordkeeping; DSCSA, the Poison Prevention Packaging Act, and HIPAA add supply-chain, packaging, and privacy duties. In Virginia, the Drug Control Act (Va. Code § 54.1-3400 et seq.) and the Board's regulations (18VAC110-20) supply licensing, dispensing, counseling, and PMP rules.
The idea to internalize
Federal law sets a floor; a state may be stricter but may not authorize what federal law prohibits. Virginia maintains its own schedules, so a substance can be controlled in Virginia even if DEA has not scheduled it, and Virginia may place a drug differently than the federal schedule. When rules conflict on how permissive conduct may be, satisfy both sets of requirements and follow the more restrictive one.
Traps
- Assuming "not federally scheduled" means "not controlled" in Virginia.
- Forgetting that DEA registration is location-specific and separate from the state pharmacy license.
- Missing that the PMP is a state program with its own query and reporting mandates, independent of federal rules.
Worked example
A product contains a substance Virginia lists in Schedule IV but DEA does not control. A Virginia pharmacy handling it follows Virginia controlled-substance documentation and inventory rules, but no DEA registration number appears on the prescription because no federal control attaches. When both governments control a drug, both paperwork regimes apply.