News and information useful to Cleveland-Marshall College of Law students, faculty and staff.

Archive for June 10th, 2016


FDA Warning Letter Sent to Ohio-Based Compounding Pharmacy

FDA logoThe U.S. Food and Drug Administration (FDA) recently sent a warning letter to RXQ Compounding LLC in Athens Ohio, finding deficiencies in how the outsourcing facility was producing drugs.  Outsourcing facilities* must comply with Federal Food, Drug, and Cosmetic Act (FDCA; Pub. L. No. 75-717, 6/25/38) provisions, including those on “current good manufacturing practice” [21 CFR 210, 21 CFR 211] and insanitary conditions [21 U.S.C. § 351(a)(2)(A)].  FDA investigators inspected RXQ Compounding from 8/24/15 through 9/21/15, and “observed serious deficiencies in … practices for producing sterile drug products,” as well as the outsourcing facility “failed to meet the conditions of section 503B.”  FDA issued a Form 483 to RXQ Compounding on 9/21/15, and RXQ Compounding sent responses in October and December 2015, but the FDA stated some of the proposed corrective actions “are deficient or could not be evaluated.”  The FDA warned RXQ Compounding that failure to “take prompt action to correct the violations … may result in legal action with further notice, including, without limitation, seizure and injunction.”  For additional information on FDA inspections and enforcement actions, see the FDA Inspections, Compliance, Enforcement, and Criminal Investigations page.         [*See 21 U.S.C. § 353b, created by the Compounding Quality Act (Title I of the Drug Quality and Security Act, Pub. L. No. 113-54, 11/27/13), which added Section 503B to the FDCA.]