Drug Reclamation/Donation Regulations

At a global level, the World Health Organization has developed international drug donation guidelines for humanitarian relief as a basis for national and institutional guidelines. At the federal level, the US Food and Drug Administration and other federal regulators such as the Drug Enforcement Agency have not developed regulations specific to drug donation programs. As a result, state drug donation or reclamation programs are largely governed at the state level and vary greatly from state to state. In general, enabling legislation must be passed by a state legislature, and participating entities such as a community pharmacy or wholesale drug distributor are regulated by their respective State Board of Pharmacy. Specific administrative rules for a drug donation program are often developed by the state’s Department of Public Health, Department of Health, or Board of Pharmacy. 

Most state programs have substantial restrictions on who can donate and what types of prescription products or supplies may be donated. For example, some states only allow certain classifications of medication, such as anti-cancer medications to be donated. In addition, very strict patient safety rules apply to ensure the integrity of medications distributed, as well as income and insurance (or lack of) guidelines to ensure donated medications are provided to the state’s most indigent or vulnerable populations.

Most state programs have a number of common provisions including:

  • No “controlled substance” medications may be accepted or transferred.
  • All prescription drugs or over the counter medications must be inspected by a pharmacist prior to being distributed or dispensed. 
  • No adulterated, misbranded or mislabeled medication may be accepted or transferred.
  • No expired medications may be accepted or transferred. (Many states require a minimum of 6 months beyond use dating)
  • All medications must be unopened and in original, sealed, tamper-evident packaging.

Some differences in provisions across states include:

  • Classes of medication accepted for redistribution. (Such as prescription-only, over the counter, or disease-specific such as anti-cancer)
  • Eligible donors (Such as pharmacies, health providers, individuals) 
  • Eligible recipients (Such as a clinic, pharmacy, or direct to patient)
  • Patient eligibility (Income standards, uninsured, or underinsured status)
  • Protocol for transfers and repackaging
  • Dispensing fee for donated medications (Allowed or not allowed, monetary cap)
  • Centralized/decentralized (One statewide entity versus local programs)
  • Program funding (State assistance provided or strictly charitable)

Drug donation programs are quickly being established by states. They function as practical channels to connect patients in need of assistance with unused prescription medications, and ensure that obsolete medications are appropriately disposed of. As more states move to make drug donation programs operational, it is imperative that program leaders and stakeholders work with state and federal regulatory agencies to ensure drug donation and reclamation programs flourish.

See the Appendix for state drug donation rulesadopted by specific states. See Appendices\Regulatory\Sample State Regulations.

Direct Donations from Manufacturers

See Manufacturer Bulk Replacement.