Drug Quality & Security Act (DQSA)
and the Drug Supply Chain Security Act (DSCSA)
DSCSA Background Information
What are the Drug Quality and Security Act (DQSA) and the Drug Supply Chain Security Act (DSCSA)?
The Drug Quality and Security Act (DQSA) established requirements on compounding safety and security of pharmaceutical products. Title 11 of DQSA, known as the Drug Supply Chain Security Act (DSCSA) applies to us and mandates consistent traceability of pharmaceutical products through the national supply chain from manufacturers to pharmacies. The new federal law negates all state pedigree requirements, implementing a national standard for traceability, and places the industry under the purview of the Food and Drug Administration (FDA).
How will the TI, TH, TS data appear to Pharmaceutics customers?
Customers will need to call the main office (781-449-9200) to obtain the following data:
Transaction Information (TI):
- Product name
- Product strength and dosage form
- Product container size
- Number of containers
- Transaction date
- Shipment date
- Name and address of previous and subsequent business owner
Transaction History (TH):
- Transaction information for each prior transaction, going back to the manufacturer
Transaction Statement (TS):
Statement demonstrating transfer of ownership of the product, verifying that:
- Product is authorized under DQSA
- Product was received from an authorized party
- T1 & TS were received from the previous seller
- Entity did not knowingly ship suspect or illegitimate product
- Entity has systems and processes in place to capture and investigate suspect product
- Entity did not knowingly provide false or altered transaction data
Are all products impacted by DSCSA?
- Not all pharmaceutical products are impacted by the new law.
- The following items fall outside the transactional mandate and are not impacted. TI, TH, and TS data will not be required for these items:
- Over the counter (OTC) products
- blood and blood components intended for transfusion
- radioactive drugs and radioactive biologics
- imaging drug
- intravenous products
- medical gas
- compounded drugs
- dispensing drugs pursuant to a prescription
- medical convenience kits and combination products
- sterile water and products intended for irrigation
Details on Onboarding Pharmaceutics Customers (Pharmacies & Dispensers) to Receive the DSCSA Transaction Data by July 1, 2015
How will Pharmaceutics partner with customers to help them obtain the transactional data as required by DSCSA?
- As of July 1, 2015 customers will need to call our office (781-449-9200) to retrieve the Transaction Information, Transaction History, Transaction Statement (TI, TH, and TS) data from Pharmaceutics.
How do I receive the TI, TH, TS data?
- The data will be available by calling the main office.
What data is available in The Sky?
- The required TI, TH, TS data will be available.
How do I search for the TI, TH, TS data as it pertains to a certain shipment or product?
- You can search by invoice number or date of purchase.
How long does the data need to be stored?
- The data needs to be stored for six years, by mandate of the law.
How does DSCSA affect returns?
- Saleable Returns
- You may return product to Pharmaceutics, if you received the product from us.
- You do not need to provide TI, TH, TS data with a return under the law's requirements.
- If you receive more product than you ordered, please contact Customer Service so they can assist you in obtaining the corresponding TI, TH, TS data.