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, October 31, 2013
State Senate compounding bill exempts hospital pharmacies By Chelsea Conaboy | GLOBE STAFF OCTOBER 31, 2013
The state Senate passed a bill Wednesday requiring compounding pharmacies that custom-mix sterile drugs to obtain a special license from the state pharmacy board, submit to annual inspections, and report more information about their operations. But, unlike the plan approved last month by the House, it temporarily exempts a large segment of the industry: hospital pharmacies.
Instead, the bill would create a commission to review oversight of hospital pharmacies and make recommendations by July 2015. If no change is made by then, the hospitals would become subject to the same rules as other compounding pharmacies.
“A hospital is a very different setting from a manufacturer's setting,” said Anuj Goel, vice president of legal and regulatory affairs at the Massachusetts Hospital Association. He noted that hospitals monitor their drug quality and are subject to outside reviews conducted by accreditation boards and the Centers for Medicare & Medicaid Services, which are not done at wholesale drugmakers. “Hospitals have always been and continue to be regulated.”
But federal site visits to hospital pharmacies happen irregularly, and state inspections are done as part of overall hospital licensing. The state pharmacy board now has no role in inspecting the hospital pharmacies, though it does license their pharmacists.
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Senate has adjoined; Schedule for Monday November 4, 2013
We prepare a Daily Summary with each day's expected Senate schedule.
Senate Floor Schedule for Monday, November 4, 2013
The Senate stands adjourned until 2:00pm on Monday, November 4, 2013. Following any Leader remarks, the Senate will resume consideration of the motion to proceed to S.815, the Employee Non-Discrimination Act. During Thursday’s session of the Senate, cloture was filed on the motion to proceed to S.815. At 5:00pm, the Senate will proceed ...
November 4, 2013
The Senate stands adjourned until 2:00pm on Monday, November 4, 2013. Following any Leader remarks, the Senate will resume consideration of the motion to proceed to S.815, the Employee Non-Discrimination Act. During Thursday’s session of the Senate, cloture was filed on the motion to proceed to S.815. At 5:00pm, the Senate will proceed ...
November 4, 2013
FDA outlines plan to combat drug shortages Toni ClarkeReuters Facebook Twitter LinkedIn GooglePlus Email 41 minutes ago
The Food and Drug Administration released a strategic plan for preventing drug shortages Thursday and proposed a rule to require drug and biotechnology companies to promptly notify the agency of potential disruptions to the supply of medically important drugs.
The plan and proposal come in response to a 2011 order from President Barack Obama to solve the problem of drug shortages. Between 2005 and 2011 the number of new shortages quadrupled to 251. That figure declined to 117 in 2012 but there were still more than 300 ongoing shortages at the end of the year.
The 2012 Food and Drug Administration Safety and Innovation Act called for the FDA to improve its response to imminent or existing drug shortages and to address the underlying causes. The act also gave the FDA new authority to require drug manufacturers to notify it of potential supply disruptions.
KUDOS to Michigan AG: Home Metro Michigan October 31, 2013 at 10:41 am Michigan AG seeks license suspension for South Lyon pharmacy Lauren Abdel-Razzaq The Detroit News
The Michigan Attorney General’s Office is seeking a license suspension for a South Lyon pharmacy recently linked to the distribution of tainted injections.
An administrative complaint was filed Tuesday against pharmacist Kenny R. Walkup Jr., and his operation Specialty Medicine Compounding Pharmacy. Attorney General Bill Schuette filed the complaint in conjunction with Steve Arwood, the director of the Department of Licensing and Regulatory Affairs.
Schuette also moved to suspend Walkup’s controlled substance license.
According to the complaint, Henry Ford Hospital notified the Food and Drug Administration on Oct. 17 after they found multiple vials of unexpired dextrose injections, which were a green and brown color. Tests showed the injections contained two types of mold and fungus.
“There is the potential that products received by Michigan facilities have been contaminated,” the complaint says. “Respondent allowed an adulterated product to be shipped to Michigan health facilities leading to an imminent public health threat in the State of Michigan as it is unknown how many products were contaminated and administered to patients.”
Because of the amount of the drug produced, it is believed Walkup was producing the drugs before his manufacturing license had been approved, court documents say. The complaint also questions whether Walkup’s facility is a sterile environment.
Walkup issued a voluntary recall of the tainted products on Oct. 19. The products were distributed to hospitals and individual consumers across the state beginning July 1. For a complete list of the recalled products, visit http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts.
“Michigan citizens trust pharmacists to follow the laws designed to keep consumers safe,” Schuette said in a statement. “As soon as the tainted drugs were reported, we moved swiftly to protect public safety and welfare, and we have launched an official investigation to determine whether additional civil or criminal action is warranted.”
The complaints come amid a massive review of state regulations for compounding pharmacies after a meningitis outbreak linked to New England Compounding Center in Massachusetts.
The pharmacy is alleged to be behind 264 infections and 19 deaths in Michigan, according to the most recent data available from the Centers for Disease Control and Prevention and the Michigan Department of Community Health.
lrazzaq@detroitnews.com
(313) 222-2127
(313) 222-2127
From The Detroit News: http://www.detroitnews.com/article/20131031/METRO06/310310091#ixzz2jK7k3cWW
AG calls for suspension of compounding pharmacy's license : Specialty Medicine Compounding Pharmacy Oct. 31, 2013 11:19 A
State Attorney General Bill Schuette is calling for the suspension of a South Lyon compounding pharmacy's license following a precautionary recall of the pharmacy's injected products.
Schuette announced this morning he was filing a complaint against Specialty Medicine Compounding Pharmacy seeking the suspension of the pharmacy's license, as well as the suspension of pharmacist-owner Kenny Walkup Jr.’s pharmacist and controlled- substance licenses.
The Department of Licensing and Regulatory Affairs has confiscated all controlled substances at the facility in South Lyon, and Specialty Medicine Compounding Pharmacy has been forced to cease operations.
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Track & Trace: Are We Talking Mars Flight When We Can't Get to the Moon?
Hedley Rees, Managing Consultant, PharmaFlow
Wednesday, October 30, 2013 11:00 EDT
This interview appears in CPhI's Annual Report, Part 2, which was formally released last week at CPhI 2013 in Frankfurt.
Wednesday, October 30, 2013 11:00 EDT
This interview appears in CPhI's Annual Report, Part 2, which was formally released last week at CPhI 2013 in Frankfurt.
CPhI: What impact do you expect the EU Falsified Medicines Act and US FDASIA to have on the industry?
HR: The EU was first to legislate on adulteration and counterfeit issues in 2011. The subsequent consultation on the associated GDP/GMP tightening was fraught with issues raised by supply chain actors that would be impacted.
For example, one area of confusion was the requirement to apply for a wholesale dealer license for any company storing materials for more than 24 hours, and in the case of cold chain, licenses would be required if they were handled at all. The ensuing uproar (especially from the third party logistics providers) resulting in that requirement being abandoned, as happened to a number of the initial proposals.
Even now, there are still practical issues with the new regulations, such as the requirement for materials sourced from third countries (outside EU) to assure EU GMP equivalence. That is still a moving feast, as is the requirement to assure transparency of materials right the way up to original source -- how many Pharma companies can claim they have that?
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FDA Sets New Rules to Combat Drug ShortagesThe agency will require more notification of impending supply changes.
October 31, 2013
The Food and Drug Administration is taking measures to further address the problem of drug shortages, The Wall Street Journal reports.
The FDA will share a new federal rule and plan on drug shortages on Thursday, which will add to an order signed by President Obama in 2011 and passed by Congress in 2012
The law will require companies to let the FDA know about any temporary manufacturing situations that would endanger drug supply, or of any plans to cease production of drugs in short supply. The agency would then find alternate manufacturers to make the drug.
The number of notifications of coming shortages by companies to the FDA increased sixfold since the presidential order in 2011, but doctors and researchers say there is much still to do.
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Mass. Senate OKs compounding pharmacy crackdown AP / October 31, 2013
BOSTON (AP) — The Massachusetts Senate has unanimously backed stricter regulations on drug compounding pharmacies like the one blamed for a deadly nationwide meningitis outbreak.
The Senate bill establishes sterile compounding and complex non-sterile compounding specialty licenses to be issued by the Board of Registration of Pharmacy. It also requires inspectors to conduct planned and unplanned inspections of pharmacies.
The vote follows passage of a similar measure by the Massachusetts House earlier this month.
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Senate Hotlines Compounding Bill After Agreeing To Vote On Vitter's Exchange Subsidies Amendment
Senate leaders Wednesday (Oct. 28) hotlined floor action on compounding legislation and as part of the move will vote on Sen. David Vitter's (R-LA) amendment that would bar members of Congress and cabinet officials from getting federal subsidies to help pay for health insurance on the exchanges.
from Inside Policy Health.com Note Wednesday was October 30, rather than the 28th.
Piqua Compounding Pharmacy Issues Press Release Announcing Is First Worldwide to Add High-Tech Mixing System to Ensure Accuracy, Efficiency
PRWEB) October 31, 2013
The Piqua Compounding Pharmacy in Piqua, Ohio is the first compounding pharmacy in the world to add a Resodyn LabRAM resonant acoustic mixing system.
The system, manufactured in Butte, Montana, is routinely used in the pharmaceutical, cosmetics, and ceramics industries.
The use of the LabRAM will help the pharmacy ensure that prescription dosages contain the exact amounts of active pharmaceuticals needed for individual patients in the 98 to 102 percent range.
This technology is 30 to 50 times more accurate than other compounding pharmacies and rivals pharmaceutical manufacturers, said Jeff Hogrefe, Piqua pharmacy owner.
The pharmacy has partnered with Resodyn Corporation since August of 2012 to develop an expertise in using the high-tech equipment. The United States Pharmacopeial Convention (USP), national oversight agency for compounding pharmacies, requires that compounded products attain accuracy in the 90 to 110 percent range.
There are 36,000 family-owned compounding pharmacies in the United States
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Wednesday, October 30, 2013
So if no amendments affecting compounding to HR 3204 then that will mean the legislative intent is to exclude veterinary compounding from the Federal legislation at this point. So if pharmacy only sells veterinary compounds no impact as far as outsourcing etc. If pharmacy does both human and veterinary, then only human part impacted if voluntarily register. Thoughts, ideas, arguments???
HR 3204 Bill Will Most Likely be Voted on by US Senate Tomorrow, October 31, 2013
IACP is reporting that Senator Reid has requested unanimous consent to bring HR 3204 to floor vote with one amendment requested that does not relate to compounding.
Comment regarding repackaging
It appears that Dr. Kliger, an ophthalmologist, wants to have repackaged compounded drugs (such as Avastin) included in this bill, to ensure that non-patient specific doses of compounded Avastin could be in his clinic, so he could inject them on any day, rather than waiting for a compounding pharmacy to send him a patient-specific prescription. There are a few flaws in Dr. Kliger's argument, however. 1. Perhaps "the best compounding pharmacy" for ophthalmic drugs, Leiter's, is located in his state of California. Prescriptions from a pharmacy in his state could arrive within one day, two days max, if expedited shipping is used. For chronic conditions such as macular degeneration (the condition that Avastin and Lucentis is used for), there is no urgency to inject "right away". It does make it more convenient to both the doctor and patient to have these drugs "on hand" in the doctor's office, and less expensive too (less shipping fees and/or waste due to unused product), but it is not a on Interesting article says drug safety bill puts urgent treatment in jeopardy. I thought bad compounders like necc who refuse to follow the rules cause far greater jeopardy
Kenneth Woliner, MD
Kenneth Woliner, MD
Who Is and Was the Alliance for Natural Health (American Association for Health Freedom); View there most Recent IRS Form 990--the author of this blog acknowledge that she has previously worked at the IRS in the Exempt Organization Division but to her knowledge never did any work related to this organization. and in any event here role at the IRS was to work with and grant or deny 501(c)(3) status
About Us
The Alliance for Natural Health USA (ANH-USA)* is part of an international organization dedicated to promoting sustainable health and freedom of choice in healthcare through good science and good law. We protect the right of natural-health practitioners to practice and the right of consumers to choose the healthcare options they prefer. Since 1992, we have worked to shift the medical paradigm from an exclusive focus on surgery, drugs, and other conventional techniques to an “integrative” approach incorporating functional foods, dietary supplements, and lifestyle changes. We believe this is the way to improve health and extend lives while reducing the costs of healthcare back to a sustainable level.
ANH-USA is committed to sustainable health, the recognition that our environment and our physical health are inextricably related. If we run out of clean water to drink, pure air to breathe or nutritious and uncontaminated food to eat, or if through our prescription drugs and vaccines we are poisoned by mercury or phthalates, our physical health will suffer.
Sustainable health also applies the environmental ethic of conservation to our bodies. It urges us to live as nature intended us to live. Diet , dietary supplements, exercise, and the avoidance of toxins are especially important tools in building and maintaining health.
Sustainable health is also about financial sustainability. Ever higher healthcare costs lead directly to higher unemployment and lower standards of living, both of which lead to more illness.
Today, preventive medicine is too often defined as taking more and more drugs at an earlier and earlier age, even in childhood. The concept of sustainable health is real preventive medicine and will dramatically reduce healthcare costs.
ANH-USA ensures your right to choose a sustainable and preventive approach to health along with nutritional and “integrative” healthcare. We lobby Congress and state legislatures, act as a government watchdog, file comments on proposed rulemakings, and educate the public, press and other decision-makers.
You may view our most recent IRS Form 990 here.
* ANH-USA was formerly the American Association for Health Freedom.
quoted from here
WellPoint Excluding Some Compounded Drugs From Coverage
As of November 1, 2013, WellPoint will no longer pay for compounded medications that are made from bulk ingredients. WellPoint plans include Anthem Blue Cross and Anthem Blue Cross Blue Shield.
For a compound drug to be covered it must contain at least one ingredient/drug that requires a prescription to obtain. Additionally, that ingredient/drug must also be approved by the Food and Drug Administration (FDA). Drugs impacted include:
- Compounded bulk powders (not FDA approved)
- Pharmaceutical Adjuvants (compounding vehicles, not FDA approved)
Letters were mailed to all groups and individuals that will be affected by this change. Individuals that are impacted by this change will need to talk with their doctor about changing to a covered medication, or pay the entire cost.
Interesting article says drug safety bill puts urgent treatment in jeopardy. I thought bad compounders like necc who refuse to follow the rules cause far greater jeopardy
There are a lot of illness for which there are no treatments or cures so I am not sure I am completely convinced with this argument although I am sure there will be some such cases. What is the solution if not what is proposed? Is there a way to fix the current draft without having to start over? There have been issues with the eye med named in article. I guess it comes down to a balancing and weighing. No legislation will be perfect. Just as there never has been assess to meds for every person for every illness... harsh but true.
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Drug Safety Bill Puts Urgent Treatment in Jeopardy
By Craig H. KligerOct. 30, 2013, 3:30 p.m.We all remember the scenes in the film “Willy Wonka & the Chocolate Factory” where Gene Wilder nonchalantly warns, “Stop. Don’t,” as various characters try unknown products and experience unanticipated effects. Of course, each instance ends with predictably unfortunate results.Congress’ attempt to regulate compounded medications poses a Wonka-esque scenario in which potentially well-intentioned legislation may have the unintentional side effect of harming patients and adding unnecessary costs to the health care system.
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10/29/13 - PDA/FDA Joint Regulatory Conference: Great Place to Learn From Regulators
| 10/29/13 - PDA/FDA Joint Regulatory Conference: Great Place to Learn From Regulators |
BETHESDA, Md., Oct. 29, 2013 /PRNewswire-USNewswire/ Many of the nearly 1,000 people who attended the 23rd Annual PDA/FDA Joint Regulatory Conference said the event provided them the opportunity to hear directly from regulators on the issues that affect them most, and from industry experts on how they are responding to these same issues.
(Logo:http://photos.prnewswire.com/prnh/20130226/DC66667LOGO) Co-sponsored and co-planned by the PDA and the FDA, and held in Washington, D.C., the annual conference has become the place where those working in the pharmaceutical industry can join in discussions with representatives of the Food and Drug Administration to gain their perspectives. There were more than 45 FDA speakers, including Janet Woodcock, M.D., Director, CDER, FDA. Attendees come from across the globe. Many say the conference gives them more than in depth knowledge to take back to their firms. "In addition, for me as a lawyer, the many opportunities to hear directly from the FDA officials on what their current line of thinking is and what their visions on their expected policy changes are," said Daike Van de Putte, from GSK. "It was very insightful for me to learn the reasons behind such changes." Other attendees, who supply the pharmaceutical industry, said the conference helped them better understand their customers. "I came away with a deeper understanding of our customers' needs and challenges, along with critical information that enables us to become a better partner," said Ross. W. Acucena of EMD Millipore. "The 2013 PDA/FDA Joint Regulatory Conference was, as always, a priceless venue to connect with colleagues and FDA representatives," said Veronica Cruz, Ph.D., of Johnson & Johnson. The 2014 PDA/FDA Joint Regulatory Conference is scheduled for September 8-10. There is a workshop, entitled2014 PDA Drug Shortage Workshop on September 10-11. About PDAThe Parenteral Drug Association (PDA) is the leading global provider of science, technology and regulatory information and education for the pharmaceutical and biopharmaceutical community. Founded in 1946 as a nonprofit organization, PDA is committed to developing scientifically sound, practical technical information and resources to advance science and regulation through the expertise of its more than 9,500 members worldwide. PDA's Annual Meeting will be held April 7-9, 2014 in San Antonio, Texas. For information, visit www.pda.org and follow PDA on LinkedIn. Press ContactAmelia Townsend Director of SOURCE Parenteral Drug Association quoted from here |
IMPORTANT! Passage Of Compounding Safety Bill Positions TherapeuticsMD In Hormone Therapy Market Oct 30 2013, 13:58 | about: TXMD
Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. (More...)
We continue to remain positive on TherapeuticsMD Inc. (NYSEMKT:TXMD) shares, a specialty pharmaceuticals company developing advanced-stage pharmaceutical hormone replacement therapy (HRT) products. Shares of TXMD have been on the rise after the House of Representatives passed a compounding safety bill - The Drug Quality and Security Act. While the passage of the bill has surprised many, we had predicted in a previous article that the bill would likely be passed. Although the bill still has to pass through the Senate, its passage in the House is crucial having been seen as a major hurdle. Earlier in the week, the company also announced achievement of significant proof-of-concept in phase 1, first-in-class soft gel vaginal formulation TX12-004HR. In addition, the company also hired a clinical expert. Before discussing what kind of impact these developments could have on TherapeuticsMD, let us just recap what the House bill is in essence about.
Making HRT safer
As we discussed in the previous article, drugs that address a single hormonal issue or monotherapies do not work well in hormone therapy. This is due to the fact that when a drug suppresses one problem hormone, the levels of another problem hormone increase. This issue created a need for developing combination therapies for HRT. Currently, the only drugs for HRT that have been approved by the FDA are monotherapeutic bio-identicals. As a result, doctors have been forced to send women needing HRT to compounding pharmacies that create over-the-counter hormone therapies by compounding non-FDA approved synthetic drugs. These therapies unfortunately have severe side-effects such as cancer.
Medscape Medical News FDA Report Outlines Approach to Personalized Medicine Miriam E. Tucker October 29, 2013
SILVER SPRING, Maryland — In a detailed new report, the US Food and Drug Administration (FDA) has outlined its approach for regulating new personalized therapies and devices.
The report, Paving the Way for Personalized Medicine: FDA's Role in a New Era of Medical Product Development, outlines the fundamental ways in which the FDA has modified its traditional approaches to drug and device regulation in the new era of products that are tailored toward specific patient subtypes, rather than broad diagnostic groups.
"We're very, very excited about this report because I think it captures the broad context of what's happening in science and medicine today and the role of the FDA as we enter the era of personalized medicine, and for us, personalized medical product development," FDA commissioner Margaret A. Hamburg, MD, said in a press briefing held at the FDA headquarters Monday.
Dr. Hamburg noted that the European Union's definition of personalized medicine, "Providing the right treatment to the right patient, at the right dose at the right time," has always been medicine's goal.
"Now, with the advance of science and technology and the understanding of both the underlying mechanisms and the human response to disease, we have so many more opportunities to target therapies in exciting ways and really improve the care that we can offer and the effectiveness of treatments," she said
Starting in 1998 with the approval of trastuzumab (Herceptin, Genentech) for the treatment of HER2-positive breast cancers, the FDA has approved more than 100 drugs that contain specific information about biomarkers in the labeling. Sometimes that information is added postlicensure.
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[C’s Discount Pharmacy, Inc. et al. v. Louisiana CVS Pharmacy, LLC, No. 13-2989 Section “C”(3), E.D. La., 2013 U.S. Dist. LEXIS 140939]--
Here are the facts: Plaintiffs in Louisiana sold two pharmacies to CVS. Part of the agreement purchase and sales agreement included a non-competition clause prohibiting sellers from competing within 10 miles for a period of 5 years. CVS paid a stated $1.1 million for the benefits of the non-competition agreement. The agree also included a provision for a $1 million “holdback” to assure payment of the seller’s indemnification obligations. The holdback was to be paid on March 30, 2013. CVS refused, however, to pay the holdback, claiming that plaintiffs had, contrary to the non-competition agreement, competed by directing former customers of theirs to pharmacies other than CVS. Plaintiff sued to demolish the agreement.
Be sure and read this case or the summary if you are a member of ASPL and receive their e-news.
American Society for Pharmacy Law (ASPL) is accepting nominations for the Joseph L. Fink, III, Founders Award.
Joseph L. Fink III Founders Award
The American Society for Pharmacy Law (ASPL) is accepting nominations for the Joseph L. Fink, III, Founders Award. The Founders Award was established in 2004 to recognize sustained and outstanding service and contributions to the professions of pharmacy and law. The award is named for Joseph L. Fink, III, who founded ASPL in 1974 and served as the Society’s first president.
Any ASPL member may nominate a person for the Award. The nominee need not be a current ASPL member. The Award may be awarded annually, but if no person nominated meets the criteria, the award will not be given.
The award consists of a perpetual plaque kept in the ASPL office with the names of each of the past recipients, as well as an individual award for the recipient.
The award will be presented at the ASPL Annual Meeting held in conjunction with the American Pharmacists Association (APhA) Annual Meeting & Exposition to be held March 28 - 31, 2014 in Orlando, FL.
To nominate an individual for the award, please submit a nomination form and all supporting documentation to ASPL by January 17, 2014. A nomination form may be downloaded from the ASPL website here. Nomination Form (PDF).
To nominate an individual for the award, please submit a nomination form and all supporting documentation to ASPL by January 17, 2014. A nomination form may be downloaded from the ASPL website here. Nomination Form (PDF).
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