Friday, June 28, 2019

Pharmaceutical wholesaler sues owner of Lovelace Drugs in Ocean ...

Biloxi Sun Herald-18 hours ago
When Clark Levi, the owner of Lovelace Drugs, bought out his partners at Alvix ... Federal investigators say conspirators in the scheme compounded drugs for 

Court dismisses 4 counts against former Nephron Pharmaceuticals employee in trade secrets case

Court dismisses 4 counts against former Nephron Pharmaceuticals employee in trade secrets case: ORLANDO — A federal court granted a former Nephron Pharmaceuticals employee who is being sued for allegedly giving trade secrets her motion to dismiss four counts relating to the Florida Uniform Secrets Act (FUTSA).
13 hours ago - ... series, Non-binding Guidance, highlights two recent federal district court decisions implicating enforcement efforts in the stem cell and compounding arenas.

FDA warns patients and health care professionals not to use sterile products from Pacifico National Inc., dba AmEx Pharmacy

FDA is warning patients and health care professionals not to use products intended to be sterile produced by Pacifico National Inc., doing business as AmEx Pharmacy, Melbourne, Florida, due to a lack of sterility assurance. These drugs may pose a safety risk to patients.

Administration of a non-sterile drug intended to be sterile may result in serious and potentially life-threatening infections or death.

Health care professionals should immediately check their medical supplies, quarantine any drugs prepared by AmEx Pharmacy, and not administer or provide them to patients. FDA urges health care professionals, who obtained products from AmEx Pharmacy, to make alternative arrangements to obtain medications from sources that adhere to proper quality standards. Patients who have received any drug produced by AmEx Pharmacy and have concerns should contact their health care professional.

FDA investigators recently inspected AmEx Pharmacy’s facility in May 2019 and observed conditions that could cause AmEx Pharmacy’s drugs to become contaminated or otherwise pose risks to patients.

On June 25, 2019, FDA recommended that AmEx Pharmacy voluntarily recall all unexpired drugs intended to be sterile and cease sterile operations until the company takes adequate corrective actions. However, AmEx Pharmacy has not initiated the recall.

For more details on the alert, please visit: Pacifico National Inc., dba AmEx Pharmacy
For more information, please visit FDA's Human Drug Compounding web site

Thursday, June 27, 2019

How many United States Attorney's Offices will be filing Qui Tam Litigation against Compounding Pharmacies in the future and how much money will be recovered?

21 hours ago - The complaint alleges that the pharmacies improperly included the drug aripiprazole, an atypical antipsychotic drug, in compounded pain creams in order to boost the pharmacies' reimbursement for the prescriptions and that the pharmacies routinely waived patient copayment 
17 hours ago - ... Immediately After Global Settlement Triggers Powerful Remedies · OIG Report Finds a Small Percentage of Hospitals Do Not Obtain Compounded Drugs from ..
18 hours ago - The drugs Roberts prescribed include Adderall, a drug used to treat attention deficit hyperactivity disorders, Suboxone, a drug used to treat opioid addiction, and oxycodone, an opioid.
11 hours ago - FDAnews Announces — Pharmacy Compounding Regulation: A Fresh Look at Guidance, Compliance, Enforcement Webinar, July 11, 2019, 2019 ...