US Senate Posts Amended Pharma Serialization and Traceability Bill and Compounding Bill--Debated Expected Week of July 8, 2013

Posted by BRIAN DALEIDEN

The United States Senate has just introduced the amended pharmaceutical track and trace bill in preparation for the upcoming full Senate floor debate of the measure.

Entitled the "Pharmaceutical Quality, Security, and Accountability Act", this bill is the result of the merging of the compounding and drug security bills which were passed earlier in June by the Senate HELP committee.

The new consolidated bill includes certain amendments to the drug security bill previous passed by the HELP committee. Highlights include:

• Provisions for Manufacturers to provide transaction history, information and statements in a single document, paper or electronic, to downstream trading partners
• Verification procedures for Manufacturers, Wholesale Distributors and Dispensers in the event of potentially suspect product that should specifically include the standardized numerical identifier when verifying the package starting on or after the respective serialization deadlines for each industry segment

Debate on the bill in the full Senate is expected the week of July 8th. If the bill passes, it will have to be reconciled with the House drug security bill that differs on a few key components.

To hear a detailed breakdown of the serialization, transaction traceability, product verification and other provisions of both the Senate and House bills, you can watch a streaming replay of our analysis here: Federal Pharmaceutical Serialization and Traceability Webinar. Or, drop us a note and we'd love to discuss what the potential national legislation would mean to your business!

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FDA Cracks Down On Online Pharmacies Selling Counterfeit Drugs Posted: June 30, 2013 Author: Jennifer Walker-Journey

The Food and Drug Administration (FDA) and Interpol are cracking down on online pharmacies for selling counterfeit or substandard medication, or selling drugs without appropriate safeguards. To date, 1,677 sites have been shut down and several others have received warnings. Fifty-eight people have been arrested and more than $41 million worth of illegal medications have been seized.

Many of these illegal pharmacies have names similar to legitimate pharmacies. For example, one of the online pharmacies the agencies have closed is Walgreens-Store.com, a play off of the legitimate Walgreens.com website.

Many of these sites advertise popular drugs such as Viagra and Celebrex. However, the drugs actually contain fake ingredients. The agencies say it is difficult to know how many deaths or serious reactions these errant medications have caused.

The National Association of Boards of Pharmacy recently assessed more than 10,000websites for online pharmacies and found that 97 percent fell short of meeting state and federal guidelines, and 88 percent did not require a valid prescription. Nearly half of the pharmacies reviewed sold medications that had not been approved by the FDA.

The National Association of Boards of Pharmacy features an approved list of online pharmacies. If in doubt, consumers can verify the authenticity of a site first, if the website asks for a valid prescription, and secondly if they have a licensed pharmacist available for consultation. The pharmacy should also be located in the United States and licensed in the state where the website is registered.

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Monday, July 1, 2013 Drug Companies Try to Ban Compound RX for Vets Today's Medical Monday deals with a critical issue to pet health care--a Vet's take on need for compounded drugs

Today's Medical Monday deals with a critical issue to pet health care.

My Meds Matter, a medical watchdog site with a specific interest in custom compounded medications, recently posted an alert about a proposal coming before the U.S. Senate. If passed, this proposal would effectively ban pharmacies from compounding medications prescribed by veterinarians to treat dogs, cats, and horses.
According to My Meds Matter, "customized medications can make all the difference is the world when these animals have a health issue.

The most egregious provision under consideration would limit the bulk ingredients that can be used in compounded medications to treat dogs, cats and horses to a positive list developed by the FDA.

There are no similar restrictions for elephants, giraffes, hamsters, other minor species— not even humans!

This could mean the elimination of important drug therapies that dogs, cats and horses depend on."

What's behind this push to ban compounding drugs? Apparently it's sponsored by the Animal Health Institute (AHI), a group created and funded by the big drug companies. Their member directory reads as a Who's Who of the world's major pharmaceutical companies: Abbot Laboratories, Bayer, Merck, Boehringer Ingelheim, Novartis, Zoetis
continue to read here

AMA meeting: Compounding pharmacies need more oversight-■ The recommendations come as some physicians note it is critical for them to have compounded drugs available quickly. By PAMELA LEWIS DOLAN amednews staff — Posted July 1, 2013

Chicago Compounding pharmacies should comply with tighter restrictions, according to a report approved by the American Medical Association House of Delegates.

The house adopted a report with recommendations that compounding pharmacies comply with current U.S. Pharmacopeia and National Formulary compounding regulations concerning uniformity, quality and safety. The report also encourages state boards of pharmacy, which regulate the traditionalcompounding pharmacy industry, to require those pharmacies to adhere to sterile compounding practices. The report further recommends that large compounding pharmacies that introduce drugs into interstate commerce be regulated by the U.S. Food and Drug Administration.

The report, approved at the AMA Annual Meeting in June, was heavily debated during reference committee testimony, as some doctors argued that tighter restrictions could limit their access to compounded pharmacy products, placing patients at risk of not receiving necessary treatments in adequate time.

Compounding refers to the act of combining, mixing or altering pharmaceutical ingredients to prepare a customized medication for a patient. Traditional compounding is done by pharmacists for individual prescriptions. The AMA wants compounding facilities that mass produce compounded products to be recognized as “compounding manufacturers” that are subject to FDA regulations.

The reference committee said the report was prepared in response to widespread concerns about the safety of pharmacy compounding and the extent to which the products were deeply embedded in the U.S. health care system. The issue arose in 2012 when a meningitis outbreak that killed 58 people and sickened 700 others was linked to a compounded injectable product manufactured in Massachusetts.

Ophthalmologists share concerns

According to the FDA, compounding, “if done properly, can serve an important public health need if a patient cannot be treated with an FDA-approved medication.” Several ophthalmologists underscored this point during testimony when they spoke of the need for compounded medications to treat conditions such as macular degeneration, which could lead to loss of sight if treatment is delayed. Physicians buy these drugs to keep on hand in the office for such cases.

Sam Solish, MD, chair of the AMA Ophthalmology Section Council, said the section supported the concept of the report but said compounded drugs are essential to many ophthalmology practices, since some antibiotics needed for the eyes are available only in compounded form. Doctors must have those medications on hand to treat patients at the time of diagnosis, said Dr. Solish, who practices in Portland, Maine.