After a thorough review of state regulations, with input from legal counsel regarding Proin, Henry Schein Animal Health - Regulatory Affairs (HSAH RA) has confirmed that there are only five states that consider Proin to be a controlled substance.
Proin contains Phenylpropanolamine or “PPA” and is considered to be a Schedule 3 controlled substance in Oregon
and a Schedule 5 controlled substance in Arkansas
, and West Virginia
For the remaining 45 states that do not classify Proin as a control substance, HSAH RA will only need to validate that the customer has a valid and active DVM license at the time an order is placed.
For those customer that reside in Oregon, Arkansas, Iowa, Louisiana and West Virginia, HSAH RA will verify that those customers have a current and valid federal DEA, state controlled license (if required), DVM license and a DEA Compliance Form (DCF) on file prior to filling Proin orders. Although there are no federal DEA requirements for veterinarians to track their phenylpropanolamine sales, veterinarians are responsible for understanding and following all state regulations.
As of 11/07/2016,
HSAH RA will implement this change going forward. In order to implement this regulatory change there will be two different item numbers for each strength and quantity of Proin. The current set of item numbers will continue to be used for the states that consider Proin to be a controlled substance - Oregon, Arkansas, Iowa, Louisiana and West Virginia. The second set of item numbers will be the non-controlled substance item numbers for Proin. Both sets of item numbers are shown below for your reference.
Existing Proin- CS Item Numbers
New Proin- Non-CS Item Numbers
|25 mg-60 ct
||25 mg-60 ct
|25 mg- 180 ct
||25 mg- 180 ct
|50 mg- 60 ct
||50 mg- 60 ct
|50 mg- 180 ct
||50 mg- 180 ct
|75 mg- 60 ct
||75 mg- 60 ct
|75 m- 180 ct
||75 m- 180 ct
We anticipate that this requirement will provide regulatory relief for customers who wish to purchase Proin from HSAH. This change supports our mission to provide the best customer experience and allow our customers to obtain the products they need in a timely manner. If you have any questions regarding this new process, do not hesitate to contact HSAH Regulatory at SOM@henryscheinvet.com