Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary
Compounding Law; Health Care; Awareness of all Types of Compounding Issues;
Pharmacy Benefit Managers (PBMs), Outsourcing Facilities
Food and Drug Administration and Compliance Issues
Thursday, January 28, 2016
Must Read: Federal Criminal Charges Filed Against Two Pharmacists for Adulteration of Drugs in Connection with Alabama--based Compounding Pharmacy
Department of Justice
Office of Public Affairs
FOR IMMEDIATE RELEASE
Thursday, January 28, 2016
Federal Criminal Charges Filed Against Two Pharmacists for Adulteration of Drugs in Connection with Alabama-Based Compounding Pharmacy
A criminal Information was filed today in the U.S. District Court for the Northern District of Alabama against David Allen, former pharmacist-in-charge of the now-defunct compounding pharmacy Advanced Specialty Pharmacy doing business as “Meds IV,” and William Timothy Rogers, a pharmacist and the former president of Meds IV, the Department of Justice announced today. Allen and Rogers were charged in connection with the distribution of adulterated drugs, which were compounded at the Meds IV facility and distributed to Birmingham, Alabama-area hospitals in 2011.
“The compounding of sterile drug products requires significant care, and the distribution of contaminated drug products can cause serious harm to patients,” said Principal Deputy Assistant Attorney General Benjamin C. Mizer, head of the Justice Department’s Civil Division. “This criminal case demonstrates the Justice Department’s commitment to protecting consumers and patients, and making sure pharmaceutical drugs are safe and effective.”
Allen, 60, of McCalla, Alabama, and Rogers, 48, of Hoover, Alabama, have signed plea agreements, in which both individuals have agreed to plead guilty to two misdemeanor violations of the federal Food, Drug and Cosmetic Act (FDCA) as charged in the Information. Following today’s filing of the criminal charges; the U.S. District Court will schedule an arraignment, where the defendants will be formally advised of the charges against them. Another hearing will then be set in which the defendants can enter their guilty pleas to the Court.
As alleged in the Information, Meds IV compounded various drugs for human use, including an intravenous drug known as Total Parenteral Nutrition (TPN). TPN is liquid nutrition administered intravenously to patients who cannot or should not receive their nutrition through eating. The information alleges that beginning in or around February 2011, Meds IV compounded its own amino acid solution, which it then mixed with other ingredients to form TPN.
As charged in the information, amino acid used in compounding the TPN was adulterated in the following ways: it consisted in whole or in part of a filthy, putrid, or decomposed substance, namely Serratia marcescens (S. marcescens) and it was prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth or rendered injurious to health. S. marcescens is gram-negative bacteria that can cause bloodstream infections if introduced into the bloodstream through contaminated medications. These infections can cause serious medical complications, including death, because S. marcescens is resistant to many antibiotics.
“Meds IV was in the business of compounding drugs and IV nutrition that was supposed to help patients heal,” said U.S. Attorney Joyce White Vance for the Northern District of Alabama. “Instead, because of unsanitary procedures in the mixing of liquid nutrition, contaminated IV fluid was sent to Birmingham area hospitals and a number of patients developed serious bloodstream infections. I thank the FDA and its Office of Criminal Investigations for their diligence in helping us prosecute those responsible for the failings at Meds IV which contributed to significant harm.”
According to the charging document, the amino acid was prepared by Meds IV outside a laminar airflow workbench and was kept unrefrigerated, in a room that was not sterile, in a large pot sitting on the floor, sometimes overnight, before it was sterilized and used.
As alleged in the information, between March 5 and 15, 2011, nine patients at various Birmingham-area hospitals who developed bloodstream infections caused by S. marcescens died, and several other hospital patients developed S. marcescensbloodstream infections but survived. According to the charges, all of these patients had been given TPN that was compounded and distributed by Meds IV. As alleged in the information, while a number of the patients who died had underlying conditions which may have contributed to their deaths, medical records of some patients suggest that the S. marcescens bloodstream infections were also a significant factor.
According to the information, Meds IV was notified on March 14, 2011, by a hospital in the Birmingham area, that four patients receiving TPN had tested positive for S. marcescens. The information alleges that the TPN was compounded and distributed by Meds IV and that this notification was the first time Meds IV was informed of a link between its TPN and patients testing positive for S. marcescens. The information alleges that on or around March 16, 2011, Meds IV began notifying some customers that compounding of TPN was suspended until further notice.
As noted in the information, during an inspection at Meds IV starting on March 22, 2011, investigators from the U.S. Centers for Disease Control and Prevention (CDC) found S. marcescens that was indistinguishable to the outbreak strain on a tap-water faucet, in an open container of amino acid powder and on the surface of mixing equipment that had been used to make TPN. According to the charging document, the U.S. Food and Drug Administration (FDA) and CDC investigators linked theS. marcescens to TPN that had been compounded by Meds IV.
“Americans expect and deserve drugs that are safe, effective, and that meet appropriate standards for quality, yet Meds IV contaminated and distributed drug products that resulted in serious harm to patients,” said Acting FDA Commissioner Stephen Ostroff, MD. “Such conduct cannot be tolerated, and the FDA will continue to work with the Department of Justice to pursue aggressive enforcement actions against those who place American patients at risk.”
As alleged in the Information, Allen supervised all compounding at Meds IV, was specifically responsible for reviewing and approving TPN formulations, and was also responsible for filling the individual prescriptions Meds IV received for patient-specific TPN products. The information alleges that Rogers was ultimately responsible for overseeing all of the day-to-day operations of Meds IV. Both defendants have agreed to plead guilty to two misdemeanor counts, representing the two lots of amino acid which were determined to be adulterated in violation of the FDCA. For each count, the defendants face a statutory maximum sentence of up to one year in prison, a fine of up to $250,000, or both, and a term of supervised release after any imprisonment for up to one year.
The case is being prosecuted by Trial Attorney Heide L. Herrmann of the Justice Department’s Consumer Protection Branch and Assistant U.S. Attorney Henry Cornelius of the Northern District of Alabama. They were assisted by Associate Chief Counsel Shannon M. Singleton of the Food and Drug Division, Office of General Counsel, Department of Health and Human Services. The case was investigated by the FDA’s Office of Criminal Investigations.
A criminal Information is merely an allegation and every defendant is presumed innocent until proven guilty beyond a reasonable doubt.