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, May 1, 2014
A Modern Approach to Compounded Medications--
Pharmacy Journal of New England, Winter 2013 - publishing
Indiana Passes National Uniform Medication And Penalty Reforms May 01, 2014 -
Indiana on Wednesday became the latest state to adopt all of the national uniform medication rules, penalties and testing reforms developed by the Racing Medication and Testing Consortium (RMTC) and adopted as model rules by the Association of Racing Commissioners International (RCI). Home to Indiana Grand Racing and Casino (which conducts Thoroughbred and Quarter Horse racing) and Hoosier Park (Standardbreds), Indiana is set to implement the new rules on May 15.
The medication schedule and penalties—formally known as the Controlled Therapeutic Medication Schedule and the Model Medication Violations Penalties System, respectively—were unanimously approved at Wednesday’s regular monthly meeting of the Indiana Horse Racing Commission. Indiana’s regulations currently meet or exceed the RCI model rule requiring third-party administration of furosemide (commonly known as Lasix) - a key aspect of the reforms - through their longstanding Integrity Program instituted in 2006. Also, Indiana recently entered into an equine drug testing agreement with RMTC-accredited LGC Sports Science Laboratory in Lexington, Ky.
Also on Wednesday, three additional equine drug testing laboratories received full accreditation by the RMTC. The labs receiving accreditation were Truesdail in Tustin, Calif., Industrial Laboratories in Wheat Ridge, Colo., and the Ohio Department of Agriculture laboratory in Columbus, Ohio. RMTC accreditation is based on protocols established by the World Anti-Doping Agency (WADA), considered the gold standard in human drug testing.
RMTC-accredited laboratories are now responsible for the testing of samples for 23 of the 34 racing jurisdictions in the United States, including Ariz., Ark., Calif., Colo., Del., Idaho, Ind., Ky., Maine, Mass., Md., Minn., N.D., Neb., N.J., N.M., Nev., Ohio, Okla., Ore., Va., Wash. and Wy. The University of California, Davis Kenneth L. Maddy Equine Analytical Chemistry Laboratory and the LGC Sports Science Laboratory were accredited in 2013.
“We applaud the state of Indiana and the Indiana Horse Racing Commission for joining the growing number of states that have adopted these important reforms in their entirety,” said NTRA President and CEO Alex Waldrop, who also chairs the RMTC. “Along with the recent RMTC accreditation of three national testing laboratories, this represents another important step toward our goal of national adoption and implementation of uniform rules, penalties and testing standards.”
The entire set of National Uniform Medication Reforms are accessible online at /feeds/testingrules.html and a current list of nearly 60 major industry organizations that have urged their adoption can be viewed at http://ntra.com/lg/IndustrySupporters.html.
- See more at: http://www.ntra.com/en/news-media/press-releases/2014/5/1/indiana-passes-national-uniform-medication-and-penalty-reforms/#sthash.DAMqtqNF.dpufAction on Federal Bills Appears Longshot
- By Tom LaMarra,
American Horse Council president Jay Hickey, who has been based in the nation's capital since 1993, said a lack of consensus in various industries makes passage of legislation difficult.
The Interstate Horseracing Integrity and Safety Act, which calls for the United States Anti-Doping Agency to regulate equine medication use and gives the agency power under the Interstate Horseracing Act, which governs interstate simulcasts, has had one hearing, Hickey said.
"Most of the (racing) industry supports uniform model reforms," Hickey said in reference to the National Uniform Medication Program. "It's a very complicated issue, and feelings are running high. We'll see if Congress and others will step in.
Read more on BloodHorse.com: http://www.bloodhorse.com/horse-racing/articles/84780/action-on-federal-bills-appears-longshot#ixzz30V7hQWAb
State Senator Michael Rush Visits Sullivan's Pharmacy
Sullivan’s Pharmacy and Medical Supply owner Greg Laham recently welcomed state Sen. Michael F. Rush (D-West Roxbury) to tour the pharmacy and discuss pending legislation related to compounded prescriptions and pharmacy audits.
During the April 11 visit, Laham described the tremendous growth of the neighborhood pharmacy, which now provides a comprehensive compounding center, prescription services for assisted-living facilities and hospice care, in addition to traditional prescriptions for the community.
“We were honored to host Senator Rush at the pharmacy,” Laham said. “He was very interested in learning more about how we compound medications to meet our patient’s individual needs. He also listened to our concerns about how audits by third-party pharmacy benefit managers are impacting independent pharmacies.”
quoted from here
During the April 11 visit, Laham described the tremendous growth of the neighborhood pharmacy, which now provides a comprehensive compounding center, prescription services for assisted-living facilities and hospice care, in addition to traditional prescriptions for the community.
“We were honored to host Senator Rush at the pharmacy,” Laham said. “He was very interested in learning more about how we compound medications to meet our patient’s individual needs. He also listened to our concerns about how audits by third-party pharmacy benefit managers are impacting independent pharmacies.”
quoted from here
The latest Health Policy Brief from Health Affairs and the Robert Wood Johnson Foundation examines the Compounding Quality Act, a law signed by President Obama in November 2013, which seeks to fill the gaps in the Food and Drug Administration’s (FDA’s) inspection and enforcement oversight of compounding pharmacies.
This law was enacted in the wake of a 2012 fungal meningitis outbreak, linked to a Massachusetts drug compounding company. The outbreak caused more than 700 people to become ill and left sixty-four dead. Before the new law was passed, compounding pharmacies were primarily regulated by states, not the FDA.
more information found here
This law was enacted in the wake of a 2012 fungal meningitis outbreak, linked to a Massachusetts drug compounding company. The outbreak caused more than 700 people to become ill and left sixty-four dead. Before the new law was passed, compounding pharmacies were primarily regulated by states, not the FDA.
more information found here
Hospira makes progress on plant problems, reports improved financials
In the past, Hospira ($HSP) competitors have been able to take advantage of the drugmaker's absence from a market because of its plant problems, filling the void and their pockets as well, at Hospira's expense. More recently it has been Hospira's chance to live large off of the quality issues of others. The company's improved Q1 earnings were, in part, due to "off contract" prices.
continue to read here
continue to read here
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