Federal Judge Enters Consent Decrees Against Two Compounders

1. Federal judge enters consent decree against compounder PharMedium Services for violations at multiple facilities

U.S. District Judge Virginia M. Kendall for the Northern District of Illinois entered a consent decree of permanent injunction today between the United States and PharMedium Services, LLC, headquartered in Lake Forest, Ill., as well as Scott Aladeen, the company’s president, and Warren Horton, vice president for Quality and Research and Development. The company has four registered outsourcing facilities located in Memphis, Tenn.; Cleveland, Miss.; Sugar Land, Texas and Dayton, N.J.  According to the complaint, despite previous warnings from the U.S. Food and Drug Administration and repeated promises from PharMedium to correct deficiencies, PharMedium continued to violate the law. 

In the complaint, the government alleges that PharMedium manufactured and distributed drugs intended to be sterile such as oxytocin and morphine sulfate, that were adulterated because the drugs were made under insanitary conditions and in violation of current good manufacturing practice requirements under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Drugs prepared, packed or held under insanitary conditions may have been contaminated with filth or may have been rendered injurious to health. The complaint also alleges that PharMedium distributed unapproved new drugs and drugs that were misbranded because their labeling did not bear adequate directions for use. 

Find details at: PharMedium Services consent decree.

2. Federal court enters consent decree against Texas compounder, Pharm D Solutions, LLC to cease the manufacturing of drugs intended to be sterile due to insanitary conditions

U.S. District Judge Keith P. Ellison for the Southern District of Texas signed and entered a consent decree of permanent injunction, ordering a Texas-based company and its owners to stop producing compounded drugs intended to be sterile until the company complies with the FD&C Act and other requirements. According to the complaint, despite previous warnings from the U.S. Food and Drug Administration, Pharm D Solutions, LLC, as well as the company’s owners, Luis R. De Leon and Juan C. De Leon, continued to violate the law, putting patients at risk.

The government alleges that Pharm D Solutions manufactured and distributed drugs, including drugs that were intended to be sterile, that were adulterated because the drugs were made under insanitary conditions and in violation of current good manufacturing practice requirements under the FD&C Act. Drugs prepared, packed or held under insanitary conditions may have been contaminated with filth or rendered otherwise harmful to patients. Additionally, the complaint alleges that some products were adulterated because they had strengths different from what they were represented to possess. According to the complaint, Pharm D Solutions also manufactured and distributed unapproved new drugs because the products did not follow all statutory requirements for outsourcing facilities. Some of Pharm D Solutions’ drugs were also misbranded because they did not include adequate directions for use.

Pharm D Solutions, LLC is voluntarily recalling all sterile compounded drug products within expiry to the consumer level. These drug products are being voluntarily recalled due to concerns that practices at the pharmacy have the potential to pose a risk of contamination to products that are intended to be sterile.

Find details at:

• Pharm D Solutions, LLC consent decree
• Pharm D Solutions, LLC Issues Voluntary Nationwide Recall of All Sterile Compounded Drugs Due to a Potential Lack of Sterility