Wednesday, July 31, 2013
Senate should act efficiently on drug compounding bill
A Senate vote for legislation that would put some compounding pharmacies under the FDA's regulatory oversight would be a crucial step even if it's not yet clear how the House will act, according to this editorial. The bill's approval would show Congress is ready to help prevent events similar to last year's fungalmeningitis outbreak tied to the New England Compounding Center.
Rep. Cummings and Tierney Release GAO Report on Drug Compounding
FOR IMMEDIATE RELEASE
Members Urge Action on Legislation to Protect Nation’s Drug Supply
Washington, DC (July 31, 2013)—Today, Rep. Elijah E. Cummings, the top Democrat on the House Committee on Oversight and Government Reform, and Rep. John Tierney, Ranking Member of the Subcommittee on National Security, Homeland Defense and Foreign Operations, released a report from the Government Accountability Office (GAO) on the oversight of pharmaceutical drug compounding.
Cumming and Tierney requested the report last year after a fungal meningitis outbreak from a contaminated compound drug led to more than 50 deaths and hundreds of illnesses.
Members Urge Action on Legislation to Protect Nation’s Drug Supply
Washington, DC (July 31, 2013)—Today, Rep. Elijah E. Cummings, the top Democrat on the House Committee on Oversight and Government Reform, and Rep. John Tierney, Ranking Member of the Subcommittee on National Security, Homeland Defense and Foreign Operations, released a report from the Government Accountability Office (GAO) on the oversight of pharmaceutical drug compounding.
Cumming and Tierney requested the report last year after a fungal meningitis outbreak from a contaminated compound drug led to more than 50 deaths and hundreds of illnesses.
You may read the full report on the Oversight Committee website by clicking here.
Congress should consider clarifying FDA's authority over compounding, GAO says--FDA officials said they had to obtain 11 warrants to gain access to drug compounders' facilities that had challenged FDA's inspection authority.”
Posted: July 31, 2013 - 7:15 pm ET
Congress should think about clarifying the Food and Drug Administration's authority to oversee drug compounding, the Government Accountability Office concluded in a report released on Wednesday.
A deadly outbreak of fungal meningitis linked to contaminated compounded drugs in 2012 led to a series of federal hearings on Capitol Hill last fall. In those heated discussions, FDA Commissioner Dr. Margaret Hamburg implored lawmakers for more clarity on her agency's authority over compounding, a process in which a pharmacist combines, mixes or changes ingredients to create a drug that is tailored to an individual's needs.
A deadly outbreak of fungal meningitis linked to contaminated compounded drugs in 2012 led to a series of federal hearings on Capitol Hill last fall. In those heated discussions, FDA Commissioner Dr. Margaret Hamburg implored lawmakers for more clarity on her agency's authority over compounding, a process in which a pharmacist combines, mixes or changes ingredients to create a drug that is tailored to an individual's needs.
Read more: Congress should consider clarifying FDA's authority over compounding, GAO says | Modern Healthcare http://www.modernhealthcare.com/article/20130731/NEWS/307319946#ixzz2agWCkXAQ
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Follow up to The Thriving Compounding Pharmacy Industry In Tampa Bay Post
Thank you to Kenneth N. Woliner, M.D., A.B.F.M for the following information:
1. Previous post entitled The Thriving Compounding Pharmacy Industry In Tampa Bay is a press release. It was put out by Father David, LLC d/b/a "Maxcare Pharmacy" (http://ww2.doh.state.fl.us/
1. Previous post entitled The Thriving Compounding Pharmacy Industry In Tampa Bay is a press release. It was put out by Father David, LLC d/b/a "Maxcare Pharmacy" (http://ww2.doh.state.fl.us/
| FATHER DAVID, LLC | ||
| LICENSE NUMBER: PH25823 | Printer Friendly Version | |
2. The supervising pharmacist is Rita Shoukry, R.Ph. She has only had a license since October 6, 2011. Not exactly years and years of experience.
3. Dr. Scott Gottleib has nothing to do with this pharmacy. He might be surprised that they are using his name (and quotes from him, supposedly from a Forbes magazine article), as a way of promoting their pharmacy. Shouldn't he be "paid" for being a spokesman for this company? If I found out that a private company was using quotes from me in this manner, I would have my lawyer send them a "cease and desist" letter, telling them to stop, and to remunerate for the false use of my name.
4. Father David, LLC d/b/a MaxCare Pharmacy is actually owned by its supervising pharmacist. This is RARE IN FLORIDA. Florida is one a few states that doesn't prohibit unlicensed persons from owning medical clinics (such as the pain clinics that have been pumping out Oxycontin, Oxycodone, Xanax and Soma - creating addicts from Florida to Kentucky to Ohio ...; such as "Rejuvination Clinics" that pump out steroids (testosterone) and Human Growth Hormone (HGH) to Major League Baseball Players such as Alex Rodriguez and Ryan Braun; such as diet clinics that pump out HCG and Phentermine ... etc. http://search.sunbiz.org/
5. The reason why I bring up the "corporate practice of ____" (medicine, pharmacy, etc) - is that Florida is a hotbed for criminal activity because unlciensed businessmen (a.k.a. the mafia) will start these clinics and pharmacies as an easy way to do Medicare/Medicaid fraud, and/or prescribe/dispense drugs without medical justification. Florida is the laughing-stock of the country. 6. Regardless, this pharmacy wants to break into the compounding pharmacy business because it is so lucrative, and because regulation and enforcement is so lax. Hopefully, the U.S. Congress will not water down the Senate Bill going through the sausage-making machine. Hopefully, Florida's Legislature will pass stricter laws, but actually enforce the laws they have. I'm not as hopeful for Florida doing its part. We don't have a good track record, and there are so many probems I've uncovered at the Florida Department of Health's Bureau of Enforcement (that are not being addressed), that I feel that Florida will feed poisonous drugs to the nation for a long time to come (just look at Franck's Compounding Lab, Signature Pharmacy, etc.). | ||
California Board of Pharmacy Webcast, Agenda and Meeting Materials for July 30-31, 2013
| July 30-31, 2013 Webcast 7/30/13 Webcast 7/31/13 | Department of Consumer Affairs 1625 N. Market Blvd. 1st Floor Hearing Room Sacramento, CA 95834 | Agenda | Meeting Materials | ||
Healthy Life Chemistry Supplement Product Contains Anabolic Steroids, FDA Warns
quoted from NABP
FDA is warning consumers not to use a product marketed as a Vitamin B dietary supplement due to the presence of potentially harmful anabolic steroids. The product, Healthy Life Chemistry by Purity First B-50, was found to contain methasterone, a controlled substance, and dimethazine, ingredients which are not listed in the product’s labeling and should not be in a dietary supplement, indicatesFDA. This product is sold online and in retail stores and FDA notes that the company, Purity First Health Products, has declined to voluntarily recall the product or to warn consumers about the potential for injury. The agency has received reports of 29 adverse events associated with use of the products, including reactions such as “fatigue, muscle cramping, and myalgia (muscle pain), as well as abnormal laboratory findings for liver and thyroid function, and cholesterol levels. Females who used this product reported unusual hair growth and missed menstruation, and males who used the product reported impotence and findings of low testosterone.” FDA advises that anyone experiencing such symptoms should consult a health care provider and warns that use of products containing anabolic steroids may cause acute liver injury and other serious long-term consequences. FDA advises health care providers to ask patients about their use of dietary supplements, particularly if patients are exhibiting symptoms that may be associated with the use of steroids or steroid-like substances. Adverse reactions should be reported to FDA’s MedWatch program either by completing and submitting an online report or by downloading, completing, and faxing the form to 800/332-0178.
Deceptive Practices By Illegal Online Drug Sellers Give Consumers a False Sense of Legitimacy and Safety, Reports NABP
Quoted from NAPB--
National Association of Boards of Pharmacy® (NABP®) recently issued a report emphasizing the deceptive practices that illegal online drug sellers use to make consumers believe that they are legitimate, safe, and trustworthy. As detailed in the Internet Drug Outlet Identification Program Progress Report for State and Federal Regulators: July 2013 (PDF), NABP discovered numerous examples of Web sites falsely claiming to be accredited through the Association’s VIPPS® (Verified Internet Pharmacy Practice SitesCM) accreditation program, sites selling counterfeit versions of brand-name drugs, and sites claiming to be Canadian that dispense prescription drugs without any prescription and sell counterfeit versions of brand-name drugs.
NABP reviews and monitors Web sites selling prescription drugs to patients in the United States and its findings are also presented in the report released last week – of more than 10,000 Web sites analyzed, nearly 97% operate out of compliance with pharmacy laws and practice standards established to protect public health in the US and many other developed countries.
Consumers in the US tend to be particularly trusting of online drug sellers purporting to be Canadian pharmacies, many of which sell drugs that are neither approved by Health Canada nor legal to sell in Canada or the US. In the last quarter alone, NABP discovered a cluster of so-called Canadian “pharmacy” sites that also offer counterfeit versions of brand-name drugs and offer to dispense prescription drugs without any prescription. NABP’s findings are supported by a July 2013 report from the US Government Accountability Office on Internet pharmacies that stated, “Many rogue Internet pharmacies seek to take advantage of this perception [of safe drugs obtained at an affordable price] by purporting to be located in Canada, or sell drugs manufactured or approved for sale in Canada, when they are actually located elsewhere or selling drugs sourced from other countries.” Furthermore, some of the medicines being sold on these Web sites may be too strong, too weak, fake, expired, stolen, diluted, or impure.
To help consumers in the US find the safest sources for purchasing medicine online, NABP developed the VIPPS accreditation program. Consumers are encouraged to look for the VIPPS Seal on an accredited site and check NABP’s list of accredited sites on its consumer protection Web site,www.AWARErx.org. The Web site is part of the AWARxE® Consumer Protection Program, provided by NABP and the state boards of pharmacy to help educate the public about the risks of Internet drug outlets, and includes news, tips, and links to relevant NABP resources.
The full news release is available in the Newsroom section of the NABP Web site.
Domperidone Not FDA Approved, Should Not be Marketed in the US, FDA Stresses
Quoted From NABP
Food and Drug Administration (FDA) stresses that domperidone is not an FDA-approved drug, and that it may not be legally marketed in the US. In June 2004, FDA warned compounding pharmacies and firms that supply domperidone for use in compounding that it is illegal to compound domperidone. In addition, FDA put into place an import alert permitting FDA personnel to detain domperidone shipments of bulk ingredients and shipments of finished drug products offered for importation without an active investigational new drug application. These actions resulted from FDA's concern about the potential health risks associated with the use of domperidone in lactating women. These risks include cardiac arrhythmias, cardiac arrest, and sudden death.
Although domperidone is not FDA approved, FDA recognizes there are some patients with severe gastrointestinal motility disorders that are refractory to standard therapy who may benefit from the use of domperidone and in whom the benefits of the drug may outweigh its risks. Domperidone is available to these patients through an Expanded Access to Investigational Drugs program. Under this program, domperidone may be obtained only from certain specified suppliers and authorization must be obtained prior to the importation, interstate shipment, and administration of the drug. According to FDA, currently the only authorized supplier of the drug is Dougherty’s Pharmacy in Dallas, TX.
Boards observing that an entity may be obtaining or compounding domperidone under circumstances not in compliance with FDA regulations are encouraged by the agency to report any concerns. Pharmacists may direct any questions to the FDA Division of Drug Information by sending an e-mail todruginfo@fda.hhs.gov or by calling 855/543-3784 or 301/796-3400.
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