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  5. Drug Supply Chain Security Act (DSCSA)
  6. Pharmacists: Utilize DSCSA Requirements to Protect Your Patients
  1. Drug Supply Chain Security Act (DSCSA)

Pharmacists: Utilize DSCSA Requirements to Protect Your Patients

DSCSA Requirements for Pharmacists

Pharmacists, or “dispensers” as referred to under the Drug Supply Chain Security Act, have responsibilities to protect patients from receiving harmful drug products. DSCSA includes requirements that pharmacies must follow to protect patients from receiving harmful drugs, such as counterfeit or other illegitimate drugs.

DSCSA creates a tighter, closed prescription drug supply chain to:

  • prevent harmful drugs from entering the supply chain 
  • detect harmful drugs if they do enter the supply chain
  • respond rapidly and effectively when harmful drugs are found

Confirm the Entities you do Business with are Licensed and Registered

To help determine whether trading partners who you do business with (manufacturing, repackagers, wholesale distributors, third-party logistics providers and pharmacies) are licensed or registered:

  • Check the registration of manufacturers and repackagers
  • Check the licensing of wholesale distributors and third-party logistics providers
  • Check the licensing of pharmacies through the respective state authority

Receive, Store and Provide Product Tracing Documentation

The law requires drugs to be traced as they move through the supply chain, and pharmacies must:

  • Only accept prescription drugs that are accompanied by product tracing documentation. If the trading partner you purchased the drugs from does not provide all this documentation, work with them to promptly get it.
  • Store the product tracing documentation you receive for six years.
  • Generate and provide all product tracing documentation with the transaction if you sell a prescription drug to a trading partner. You do not need to provide this information when you dispense a prescription drug to a patient or if you sell to a pharmacy for dispensing to a specific patient.

Investigate and Properly Handle Suspect and Illegitimate Drugs

Pharmacies must have a process to investigate and handle suspect and illegitimate prescription drugs, which includes drugs that may be or have evidence that it is counterfeit, diverted, stolen, intentionally adulterated or unfit for distribution, including steps to:

  • Quarantine and investigate suspect prescription drugs to determine if they are illegitimate; and
  • If they are illegitimate, pharmacies should work with the manufacturer and take specific steps to ensure patients do not receive the illegitimate drugs. Pharmacies must also notify FDA and the trading partners they bought the drug from and sold the drug to.

FDA offers a free 45-minute continuing education course for pharmacists to help explain DSCSA requirements.

Visit FDA's small dispensers assessment for more information.

 
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