January 1 marks the beginning of phased-in implementation of the FDA’s tracking and pedigree regulations for medications, while the first major pharmacy requirements go into effect in July.
Beginning this month, drug manufacturers and distributors must provide pharmacies with specific transaction information. They must provide a transaction history and statement that indicates product shipments down to the lot level. This change is a result of the Drug Supply Chain Security Act of 2013.
The regulations define a transaction as, “the transfer of a product between entities that results in a change of ownership.” As such, transfers of product within an organization or its affiliates are not considered transactions.
As of January 1, to be compliant with FDA regulations, pharmacies are required to have systems in place to help them identify any “suspect” products they may have in their possession. Once identified, they must also have systems in place to quarantine the supply, and conduct investigations to determine if the suspect is legitimate. However, pharmacies are not required to begin accepting suppliers’ transaction information until July 1.
Once the regulations go into effect in July, pharmacies will not be able to accept ownership of any products that do not have a transaction history, transaction information, and a corresponding transaction statement.
The track-and-trace regulations mean that many hospitals will need to train their staff on the systems used to manage product acquisition and tracking. By July 1, pharmacies must be able to capture all of the required transaction information in the drug pedigree, down to the lot level. The must be able to provide the information to certain parties who may request it.
Requests for this sort of information could be related to product recalls, illegitimate drug investigations, or any number of other potential situations. Pharmacies will be required to provide the information to the requesting party within two business days of receiving the request for information. Pharmacies are required to keep the information maintained for at least six years.
Hospitals, pharmacies, and other dispensers do have the option to enter into an agreement with a third party to maintain the necessary tracking information. However, according to regulation, any arrangement with a medication dispenser and a third party must be in writing.
According to FDA regulations implementing the Drug Supply Chain Security Act, pharmacies have at least two definitions of entities, and the definitions affect what the pharmacies are required to do and when they are required to do it.
Under the FDA regulations, a pharmacy may be a dispenser of products affected, as well as an authorized trading partner for other supply chain entities. To be authorized, the pharmacy must have a valid license under state law. Some actions taken by other supply chain entities to ensure compliance may require trading partners and dispensers to respond before the federal deadlines.
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