REGULATORY REVIEW


program, and be licensed by the states into which the products are shipped. If the state from which the drug distrib- uted by the third-party logistics pro- vider has not established a licensure requirement, it must be licensed by the FDA, but is not required to be licensed by all of the states into which the prod- ucts are shipped.


Product-Tracing Requirements The DSCSA establishes certain require- ments to ensure that all entities in the drug supply chain are able to provide information about a drug and who han- dles it each time it is sold in the US mar- ket. As of November 1, 2015, the FDA will begin enforcing these additional requirements on certain dispensers, primarily pharmacies, with respect to product tracing. This is a delay from the original deadline of July 1, 2015. The FDA noted in the dispenser guidance that trading partners are still required under the DSCSA to provide the sub- sequent purchaser with product tracing information when engaging in trans- actions involving certain prescription drugs. The FDA further noted that the DSCSA also requires trading partners to capture the product tracing informa- tion and to maintain applicable infor- mation for at least six years after the date of the product transaction. It is important for ASCs to know


whether the distributors with whom they work are compliant. They should be collecting transaction information (including lot level information, if avail- able), that could help the FDA inves- tigate suspicious products. They also must be able to transfer this information to subsequent owners of the products.


Product-Verification Requirements The DSCSA also requires certain dis- pensers, primarily pharmacies, to develop systems and processes to verify products. These dispensers must investi- gate suspect products that the dispenser or the FDA has identified as being in the dispenser’s possession or control. The investigation must be coordinated with


ASC FOCUS OCTOBER 2015 31


affected trading partners and include validating the transaction information and transaction history. If a product is illegitimate, dispensers must remove the illegitimate product from the supply chain, and take reasonable and appro- priate steps to assist trading partners in doing the same. This is another require- ment from which ASCs are most likely exempt, but it is important to under- stand the product-verification responsi- bilities that are placed on organizations with which your ASC contracts.


Future Requirements Product-Identifier Requirements The DSCSA requires a unique prod- uct identifier on certain prescription drug packages, for example, using a bar code that can be easily read electroni- cally. DSCSA provides that beginning no later than November 27, 2020, dis- pensers “may engage in transactions involving a product only if such product is encoded with a product identifier.”


Unit-Level Traceability Requirements To enhance drug distribution secu- rity, by November 27, 2023,


the


DSCSA will require dispensers to exchange transaction information and transaction statements in an interop- erable tion


electronic manner. information must include


Transac- prod-


uct identifiers at the package level. Dispensers must have systems and pro- cesses in place that will allow them to respond promptly with transac- tion information and a transaction statement for a product, as well as the information for each transaction going back to the manufacturer, upon a request by the secretary of the US Department of Health and Human Services (or other federal or state officials) in the event of a recall or for the purposes of investigat- ing a suspect product or an illegitimate product.


Kara Newbury is ASCA’s regulatory counsel. Write her at knewbury@ascassociation.org.


WE MAKE ANY PAD FOR ANY TABLE OR STRETCHER EVER MADE.


Any thickness, any size, any density.


Guaranteed best industry cost.


Visit our website for specials promotions.


SALES@ORTABLEPADS.COM • WWW.ORTABLEPADS.COM • 412.519.8728


Page 1  |  Page 2  |  Page 3  |  Page 4  |  Page 5  |  Page 6  |  Page 7  |  Page 8  |  Page 9  |  Page 10  |  Page 11  |  Page 12  |  Page 13  |  Page 14  |  Page 15  |  Page 16  |  Page 17  |  Page 18  |  Page 19  |  Page 20  |  Page 21  |  Page 22  |  Page 23  |  Page 24  |  Page 25  |  Page 26  |  Page 27  |  Page 28  |  Page 29  |  Page 30  |  Page 31  |  Page 32  |  Page 33  |  Page 34  |  Page 35  |  Page 36  |  Page 37  |  Page 38  |  Page 39  |  Page 40  |  Page 41  |  Page 42