Solution
DSCSA - Serialization
DSCSA COMPLIANCE
November 27, 2024, is the FDA's deadline for enforcement of the law
What is the DSCSA?
The FDA's Drug Supply Chain Security Act (DSCSA), enacted on November 27, 2013, requires all dispensers to comply fully by the deadline of 27 November 2024.
DSCSA is the law that requires registered monitoring of the entire supply chain to prevent counterfeit medicines from entering it.
It starts with the manufacturer to the dispenser and ends with the patient.
Why was this law created?
This federal law was created to replace state-level regulations. The main reason for its creation is to retain the upward trend in the projections of the rate of counterfeit medicines in the United States.
What is the objective of DSCSA?
The purpose of the DSCSA Act is to protect the product and the patient by: Increasing the ability to assist and protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated or otherwise harmful, and improving the detection and disposal of potentially harmful medicines.
Who are the "Business Partners" of the DSCSA?
Suppliers.
Manufacturers.
Re-Packagers.
Wholesalers/Distributors.
Third Party Logistics (3PL).
Dispensers (Pharmacy or Hospitals)
Retail pharmacy or hospital pharmacy;
A group of chain pharmacies - do not act as a wholesale Distributor.
Authorized to dispense/administer prescription drugs.
NOT included The dispensing of an approved product for use in animals
It does NOT apply to physicians who use rx drugs in their private practice procedures.
DSCSA Compliance Requirements:
These are the six requirements set out in Section 582(g)(1) by the FDA, for compliance with the DSCSA Act, which will come into effect as of November 27, 2024, for all dispensers:
Authorized trading partners must exchange transaction information (TI) and a transaction statement (TS) in a secure, interoperable, electronic manner
TI must include the product identifier (PI) at the package level for each package included in the transaction.
Authorized trading partners must have systems and processes to verify products at the package level, including the SNI
Authorized trading partners must have the systems and processes to promptly respond with the TI and TS for a product upon a request by the Secretary (or other appropriate federal or state official) in the event of a recall or for the purposes of investigating a suspect or illegitimate product.
Authorized trading partners must have the systems and processes necessary to promptly facilitate gathering the information necessary to produce the TI for each transaction going back to the manufacturer.
Authorized trading partners must have the systems and processes necessary to promptly facilitate gathering the information necessary to produce the TI for each transaction going back to the manufacturer.
Glossary.
TI - Include name or names of the product; strength and dosage form; national drug code number; container size and number of containers; Lot number; date of the transaction; Date of the shipment; Business name and address of the person from whom and to whom ownership is being transferred.
TS - Is a statement by the company transferring ownership of the product that it has complied with the DSCSA.
PI - Is a standardized graphic that carries, among other data, the product's standardized numerical identifier (SNI), lot number, and expiration date..
SNI - Comprises two data points: the National Drug Code and a unique alphanumeric serial number.
Questions and Answers:
In this section we will show you some of the most frequently asked questions through our information form.
-
Wich are the requirements under DSCSA for pharmaceutical dispensers?
Pharmaceutical dispensers, such as pharmacies and hospitals, should also verify the product identifier and certain other information before dispensing medicines to patients. They must also keep records of their transactions for at least six years.
-
Wich are some of the data items that should be tracked under DSCSA?
DSCSA requires tracking of several data elements, including product identification (such as the National Drug Code), lot number, expiration date, unique serial number, transaction dates, and transaction history.
-
What is drug serialization under DSCSA?
Under DSCSA, drug serialization refers to the assignment of a unique identifier to each prescription drug package. The unique identifier consists of a product identifier, serial number, lot number and expiry date.
-
Who must comply with DSCSA?
All trading partners involved in the distribution of prescription drugs must comply with DSCSA, including manufacturers, wholesalers and dispensers.
-
Which are the penalties for not complying with DSCSA requirements?
The penalties for not complying with DSCSA requirements can be severe. Fines may be imposed and companies may also face confiscation or prohibition of sales of products, as well as criminal prosecution.
-
What do I have to do with the transaction information?
As a customer, you are obligated to keep the information for six years. Keeping records will allow you to respond to requests in the event of product recalls or investigations related to suspicious or illegitimate products.
Product that supports this solution:
We present our portfolio of solutions designed to meet your needs in the area of DSCSA Compliance, allowing you to implement quick and specific solutions.
