Pharmacy licensing, medication procurement to destruction, professional collaborations, nonprofit status, and more are all highly regulated both on a state and federal level. The pharmacy should comply with federal laws unless the state law is more restrictive, in which case, the state law is followed. A legal partner with expertise in healthcare and general business matters is essential to maintaining best practices.
- Federal Law
- Nonprofit Status – See 501(c)3 Nonprofit Status
- Prescription Drug Manufacturing Act (PDMA) – See Donation of Prescription Drug Samples from Licensed Practitioners
- Drug Supply Chain Security Act (DSCSA) – See DSCSA – Track and Trace Legislation
- Other Food and Drug Administration (FDA) rules and regulations
- (if applicable) Drug Enforcement Agency (DEA) regulations for dispensing narcotics or controlled substances, both federal and state specific.
- (if applicable) Centers for Medicare and Medicaid Services (CMS) regulations for accepting Medicare or Medicaid payment, both federal and state specific.
- State Law
- Boards of Pharmacy rules and regulations
- Nonprofit Status and Charitable Solicitation rules (may need to review attorney general rulings)
- (if applicable) Department of Public Health rules for drug reclamation/donation programs. Some states have drug reclamation/donation rules under Board of Pharmacy.
- Local Law
- Local/County Business Codes
TIP: “Phone a Friend” – make contact and consult with State Board of Pharmacy before beginning a charitable pharmacy to ensure all requirements will be met.
States vary widely on how detailed their regulations are for charitable pharmacies, medication reclamation, and collaborative practice.
Refer to state board of pharmacy state regulations in Appendices\Regulatory\Board of Pharmacy state regulations 1.2017.xlsx.For more up-to-date information, check the individual state board of pharmacy website.
Governing law or contracts with vendors, donors or manufacturers will likely dictate:
- Who is qualified to receive medications (patient eligibility)
- Whether any charge may be made for dispensing
- Any specific requirements on storage, record-keeping, segregation, etc.
In some instances, these regulations may be very detailed and onerous. It is important to keep track of requirements and follow accordingly. Policies and procedures, staff training and use of software help make processes more manageable and trackable. See Manufacturer Bulk Patient Assistance Programs. Tips for an audit are below under Auditing.