A Tennessee state senator has been named in court papers as the physician who injected a victim of the fungal meningitis outbreak with the tainted spinal steroid that led to her lengthy illness.
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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
Wednesday, October 2, 2013
With the federal government shutdown, officials said regulators from the CDC who oversee compounding facilities are currently not on the job. "It shows why we need our government there in many aspects of our lives," says Dr. William Schaffner with Vanderbilt University's Medical Center.
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State House in Mass to Debate Tougher Pharmacy Regulations October 2nd, 2013
BOSTON (AP) — Massachusetts House lawmakers are planning to debate a bill that would clamp down on compounding pharmacies like the one blamed for a nationwide meningitis outbreak last year.
House lawmakers released the latest version of the bill on Monday and are scheduled to meet in formal session on Wednesday to debate the measure.
It’s not the only legislation aimed at increasing oversight of the pharmacies that mix customized drugs.
The U.S. House on Saturday approved legislation that would give the federal Food and Drug Administration clearer oversight of the pharmacies.
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Jan. 15 Is New Bar Date For Injury Claims Against Bankrupt Compounding Pharmacy
BOSTON - Claimants alleging injury from or contribution by bankrupt compound pharmacy New England Compounding Pharmacy Inc. (NECP) have until Jan. 15 to submit proofs of claims under a Sept. 27 order in the U.S. Bankruptcy Court for the District of Massachusetts (In Re: New England Compounding Pharmacy, Inc., No. 12-19882, D. Mass. Bkcy.).
California Pharmacist Provider Status Bill (SB 493) heads to the governor
California provider status bill heads to governor
California’s pharmacist provider status bill (SB 493) passed the state Assembly in a unanimous vote on September 11. The state Senate completed final approval September 12. Gov. Jerry Brown of California has until October 13 to act on the bill.
Introduced on February 21 by state Sen. Ed Hernandez, OD (D-24), SB 493 would declare pharmacists as health care providers with the authority to provide health care services.
“We are excited by the Legislature’s action [on September 11] to recognize pharmacists as integral members of the health care team and give them appropriate authorities consistent with their expertise,” Pat Person, BSPharm, President of the California Pharmacists Association (CPhA), said in a statement. “Thanks to Senator Hernandez’s leadership, California’s nearly 40,000 pharmacists stand ready to serve and provide greater access to quality health care.”
“We have high hopes that the governor will sign this important bill,” Jon R. Roth, CAE, CPhA CEO, told Pharmacy Today.
The state Senate approved the bill in May. All organized opposition to the bill was dropped after several amendments were made to the bill addressing some organizations’ concerns. The California Medical Association and other physician groups became “neutral” on the amended version.
The California pharmacist provider status bill is part of a package of bills introduced by Hernandez, an optometrist. Bills for nurse practitioners and optometrists did not pass out of Assembly committees, according to news reports.
SB 493 would authorize all licensed pharmacists to administer drugs and biologics by injection when ordered by a prescriber; provide consultation, training, and education about drug therapy, disease management, and disease prevention; participate in multidisciplinary review of patient progress, including appropriate access to medical records ; and order and interpret tests to monitor and manage the efficacy and toxicity of drug therapies, in coordination with the patient’s prescriber.
SB 493 would also authorize all licensed pharmacists to furnish self-administered hormonal contraceptives under a statewide protocol; furnish travel medications not requiring a diagnosis; furnish prescription-levelnicotine replacement drugs for smoking cessation under a statewide protocol; and administer immunizations to patients 3 years and older without a physician protocol.
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New Bill Would Perpetuate FDA-State Compounding Confusion
By Greg Ryan
Law360, New York (October 01, 2013, 9:47 PM ET) -- A bill aimed at revamping the regulation of compounded drugs is poised to sail through Congress, but attorneys say that by allowing manufacturers to decide whether they want to be overseen by federal or state authorities, the bill fails to clear up the very confusion that prompted its creation.
The legislation, unveiled last week, comes after nearly a year of wrangling in Washington over the best way to strengthen the oversight of compoundingpharmacies in the wake of a deadly meningitis outbreak in October 2012. At...
The legislation, unveiled last week, comes after nearly a year of wrangling in Washington over the best way to strengthen the oversight of compounding
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Alliance for Natural Health Still Urging "Urgent Action" With No time to Lose in contacting Senators and indicates if bill passes they may challenge parts of it in court
On Saturday the compounding bill passed the House by voice vote on motion to suspend the rules. The Senate could vote on it as early as today. URGENT Action Alert!
As we reported last week, the compoundingpharmacy bill we had been warning you about was scrapped because of the outcry from consumers like you. The new bill,HR.3204, the so-called Drug Quality and Security Act, was passed by the House of Representatives in a voice vote.
This means of course that there is no record of anybody’s specific vote. The chances of changing it in the Senate now are very low, but they could take up the bill under unanimous consent and voice vote as soon as today or perhaps tomorrow, so please write your senators one more time—and phone them as well!—because miracles do sometimes happen.
Let’s keep in mind the reasons why this bill, despite numerous improvements, is still so bad:
- The new bill contains sections that would ban doctors from prescribing compounded nutrients delivered intravenously unless they are on a pre-approved list, have a USP monograph, or are components of FDA-approved drugs. Imagine: your doctor cannot give you an IV containing natural vitamins and minerals unless these ingredients happen to be in some FDA approved drug! Moreover, such IVs are some of the best tools that integrative doctors have.
- The language about needing to have a USP monograph or being components of FDA-approved drugs came from an old section of the Food, Drug, and Cosmetics Act that had been deemed invalid by federal courts, so in 47 states,
physicians have recently had the freedom to prescribe and dispense compounded nutrients of their choice by IV. If the new bill passes, this will become illegal in all 50 states, at least until another legal challenge can be mounted. - The bill makes the falsification of a compounded prescription a federal criminal act. The trouble with this is that states are supposed to have jurisdiction over the practice of medicine. This will take the federal government even further into the doctor’s office.
- Also in this new bill, compounded “copies” of FDA-approved and marketed drugs would still be considered illegal. This would enable drug companies to raise
prices on some drugs to astronomical levels.
As the Senate prepares to pass this, these very bad provisions notwithstanding, we should
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