503B Consent Decree

One of the tools FDA has to enforce laws and regulations are injunctions which may leed to a consent decree.  These tools are goverened by FDA Policy. Injunctions are managed through the Office of the Chief Counsel (OCC) per FDA policy.  Of note – under 6-2-2 General Guidelines –  “If a firm has a history of violations, and has promised correction in the past, but has not made the corrections, the injunction is more likely to succeed.”  Injunctions and consent decree are typically a method of last resort to obtain compliance as the FDA expects firms to make corrections and implement corrective action to prevent reoccurance of the observation. Actions the FDA may take include but are not limited to:

  • Temporary Restraining Orders (TRO) are court enforced orders entered to control an emergency
    situation. A TRO seeks immediate, temporary relief (for a period of 10 days, which may be extended for 10 additional days) prior to the hearing for preliminary injunction.
  • Preliminary Injunction a Motion for Preliminary Injunction is subject to a full hearing in which (1) evidence by affidavit, or (2) testimony of witnesses is presented, depending on the practice of the court. Once the motion is granted, or the defendants consent to the entry of a decree, the preliminary injunction is in effect.
  • Permanent Injunction A Decree of Permanent Injunction may be entered at any time after the complaint is filed, either following a hearing or as a result of a negotiated settlement. Defendants in an injunction proceeding may consent to a Decree of Permanent Injunction just as they consent to a Consent Decree of Condemnation in a seizure action.  Should the defendant not consent to such a decree, a trial is held in which, to prevail, the  government must prove each element of its case by a preponderance of the evidence. As its name implies, a Decree of Permanent Injunction remains in effect until it is dissolved by an order of the court.

Per 6-2-4 an injunction may be considered for any significant out-of-compliance circumstance, but
particularly when a health hazard has been identified.

My impression is that the 503B community often does not understand the ramifications when communicating to FDA concerning corrections and corrective actions post inspection.  Repeat observations espically when a corrections/corrective action has been promised indicates a lack of follow-through by the firms quality department and senior managment and can set the stage for more serious actions by FDA.

Thus far in 2018 two 503B firms have received a consent decree.

The first is the Cantrell Drug Company FDA press release, DOJ press release. and the Plaintiff Brief. The inspection history of Cantrell is documented on the FDA webpage Compounding: Inspections, Recalls, and other actions reproduced below:

Cantrell Drug Company, Little Rock, AR

The second Company is Delta Pharma, FDA press release , DOJ press release, and the full Plaintiff Brief.

The inspection history of Delta Pharma is documented on the FDA webpage Compounding: Inspections, Recalls, and other actions reproduced below:

Delta Pharma, Inc., Ripley, MS


Pharmacies that chose to register as a 503B Outsourcing Facility must comply with the cGMPs.  As described by FDA:

CGMP refers to the Current Good Manufacturing Practice regulations enforced by the US Food and Drug Administration (FDA). CGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. Adherence to the CGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations. This includes establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories. This formal system of controls at a pharmaceutical company [outsourcing facility – added by author], if adequately put into practice, helps to prevent instances of contamination, mix-ups, deviations, failures, and errors. This assures that drug products meet their quality standards.

To put it simply if you do not comply with the cGMPs you are producing adulterated drugs and depending on the significants may result in voluntary (VAI) or Official (OAI) action required follwoing your inspection.

Have a question on the cGMPs in a 503B outsourcing facility?  Need help with a correction or corrective action implementation?  Contact Rick Van Doel, or use our Contact Us page and one of PVs cGMP experts will respond.

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