Table 1.

Regulating Medicine: Federal vs. state policy strategies

Regulation	Federal	State
Drug indication	FDA approval; off-label use permitted	Requires qualifying disease/symptom to be eligible for MM (27 states, 96%)
Drug efficacy	Animal and human clinical trials required for FDA approval	N/A
Drug safety	Animal toxicity testing, mandatory safety reporting to FDA during all phases of human testing and post-approval safety monitoring period	Mandates product safety testing for all MM products prior to sale (18 states, 64%)
Patient privacy	HIPAA	All states protect MM patient privacy to some degree
Patient discrimination protection	Americans with Disabilities Act prohibits discrimination based on physical impairment	Explicitly protects MM patients from discrimination (14 states, 50%)
Restricted use locations	N/A	Prohibits MM use in specified locations/facilities/situations (26 states, 93%)
Grounds for denying treatment	N/A	States explicitly authorize permit revocation (24 states, 86%)
Site safety features	Controlled Substances Act addressing supply chain security	Explicit site structural requirements (24 states, 86%)
Product dispensary restrictions	Controlled Substances Act addressing supply chain, storage and reporting of purchases and sales	Number of dispensaries per state (18 states, 64%), location (21 states, 75%), stock amount (11 states, 39%)
Product supply source	FDA secure supply chain regulations under Controlled Substances Act	Regulates dispensary supply source (25 states, 89%)
Product labeling	Requires adherence to FDA label requirements	Explicitly regulates MM product labels (23 states, 82%)
Product packaging	FDA packaging regulations	Explicit package requirements and/or restrictions (21 states, 75%)
Medical waste (unused medicine)	Controlled Substances Act regulating disposal of unused medication	Explicit waste protocols (21 states, 75%)