This article has been updated to clarify the BioCorRx’s role in the program.

The Louisiana Department of Corrections is working with BioCorRx (OTC:BICX) to offer soon-to-be-released inmates an opioid addiction treatment implant that has not been approved by the FDA.

The implant, which contains a compounded form of naltrexone, is one of several medication-assisted options being offered to 10 inmates as part of BioCoRx’s recovery program, according to the Anaheim, Calif.-based company. That program typically includes the company’s proprietary cognitive behavioral therapy, peer support and patient tracking in addition to the multi-month naltrexone implant. Inmates’ participation must be approved by prison medical staff.

The voluntary program has drawn praise from corrections officials and concern from prisoner advocates and some medical professionals, according to a report in The Advocate, a Baton Rouge, La. newspaper.

Dr. Jody Rich, co-director of the Rhode Island-based nonprofit The Center for Prisoner Health and Human Rights, wondered why the Louisiana Department of Corrections would offer prisoners an implant that does not have FDA approval.

“Consent is always problematic (in prison),” Rich told The Advocate. “The least we can do is the gold standard of medical approval … to make sure they’re safe.”

The naltrexone implant is formulated by a compounding pharmacy, which is governed by FDA regulations, according to BioCoRx. The company said it is participating in the Louisiana program to demonstrate the effectiveness of its program for those with alcohol and/or opioid use disorders while illustrating the cost and societal benefit of using the program in lieu of incarceration.

Naltrexone implants have been used worldwide for about 20 years in countless individuals, according to the BioCoRxcompany. The FDA has approved naltrexone for administration orally or by injection.

“Compounded implants have been used in the U.S. under state and federal compounding guidance for more than (two) decades,” a company spokeswoman said in an email to Drug Delivery Business. “This has been well established. Furthermore, naltrexone has been approved several times in various forms by the FDA.”

“We are passionate about individuals overcoming addiction and have seen demonstrated results from our BioCorRx recovery program nationwide,” said  BioCorRx president & CEO Brady Granier in a news release announcing the prison pilot program. “We are proud to partner with the Louisiana Department of Corrections to showcase the effectiveness of sustained-release naltrexone combined with structured behavioral therapy and peer support.”