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
Saturday, February 28, 2015
Essential Read for Pharmacists, Lawyers, and Consumers of Compounded and Repackaged Drugs: Copy of Indictment in Med Prep Consulting, along with owner Gerald Tighe and PIC Stephen Kalinoski with charges of introduced adulterated and misbranded drugs into interstate commerce with the intent to defraud and mislead the U.S. Food and Drug Administration and health care providers.
Second Question of the Day February 28, 2015 U.S. Attorney Loretta Lynch recently announced another major criminal indictment in the compounding industry against Med Prep Consulting. Lynch's nomination as the United States Attorney General was approved by a Senate Committee Last Week. Might we see the fraud and criminal activity in the compounding industry become an even higher priority at DOJ in the future?
Quote of the Day February 28, 2015 "The criminal law is a blunt tool to deal with routine industrial practices — even in cases as egregious as the New England one — and its remedies come too late for past victims of abuses. But until opportunistic politicians stop characterizing regulations as "red tape" that "kills jobs" and following Grover Norquist's promise to reduce health and safety agencies to a size where they can be drowned in the bathtub, public health will continue to be compromised." by Rena Steinzor, USAToday, Bad feds, Deadly Meds
Hot Topic! Essential Read! USA TODAY: Bad feds, deadly meds: Column Rena Steinzor 9:06 a.m. EST February 28, 2015 FDA must be equipped to regulate compounding pharmacies.
In December, the Department of Justice indicted 14 people who worked at the New England Compounding Center. The company manufactured drugs in insanitary conditions that produced a fungal meningitis outbreak that killed 64 people and made 751 gravely ill in 2012. One of the owners and a senior pharmacist face charges of racketeering and second-degree murder. more
Question of the Day February 28, 2015 How many state pharmacy boards already have in place a pecentage rule like the one below in Ohio that only allows 5 % of the pharmacy's total dollar amount of sales of patient-specific compounded prescriptions within the past twelve months? Since some states already have this type of law why are compounding pharmacies in such an uproar of the FDA allowing 30%?
A pharmacist may compound a drug pursuant to a request made by a prescriber, or by an agent of the
prescriber, for a drug to be used by the prescriber for the purpose of the direct administration to patients in the
course of the prescriber's practice if the drug is compounded and provided to a prescriber by a pharmacy as an
occasional exception to the normal practice of dispensing drugs pursuant to patient specific prescriptions. The
pharmacy shall only provide those compounded preparations where the total value of those compounded
preparations does not exceed five percent of the pharmacy's total dollar amount of sales of patient specific
compounded prescriptions within the past twelve months, the preparations are not commercially available to a
prescriber, and the preparations are used to treat an emergency situation, an unanticipated procedure for which
a time delay would negatively affect a patient outcome, or for diagnostic purposes.
[OAC Rule 4729-9-25(A)
Subscribe to:
Posts (Atom)