The Drug Supply Chain Security Act (DSCSA) tracks medications from the manufacture to the patient. This feature is a safety feature to protect patients from counterfeit medications entering into the supply chain. Currently there is no exemption for sample drug donation programs. A Donation Tracking form or software record may be used for direct donations. Both the pharmacy and the donor retain copies of the transaction.
Required information includes:
- Donor and contact information
- Pharmacy or recipient contact information
- Date of donation
- Drug name, strength, quantity in package(s), lot number, NDC if available, beyond use date (expiration) and quantity of packages
Bulk repackaging (e.g. converting bottle of 1000 to 90s, etc.) also falls under the DSCSA. Bulk repackage medications (sample meds may not be eligible for repackaging) and labeling requirements may be affected by state regulations:
Med name/ Strength/ Quantity in Package
Beyond Use Date (Max. 1 year from packaging)
Beyond Use Date is the actual beyond use date to a maximum of 1 year from packaging. See Example of Bulk Repackaging record.