Former FDA Inspector’s Crystal Ball: Cloudy With a Chance of Inspected Meatballs OCTOBER 1, 2013 BY PATRICK STONE

The FDA’s “Food Police” will be in full force to secure budget funds for food safetyinitiatives for FY 2014 as mandated by congress. More than half of the operating funds will be earmarked for food work. International food inspections will surely be a focus area for the coming year. The inspection goals/FTEs will be set low enough for the field staff to meet or exceed expectations. This again will ensure a steady flow of billions for operating costs. In recent years large chunks of the FDA budget were set for new facilities completion and the dreaded infrastructure technology (IT) upgrades which barely seem to keep up with private industry.

Opioid labeling rules newly penned will assist in identifying and tracking legal drugs, however Internet and backstreet sales will continue to plague the market. Insurance fraud is making it easier for mail-order diversion and out right second hand sales of the legally obtained opioids. So until the insurance scams are tapered this effort will only increase operating cost for the opioid manufacturers.

A medical device tax and new user fees will be required for doing business in our domestic market. It seems that every few years the fee structure increases and becomes more complex. Maybe this is part of the reason our health care cost are always going up exponentially. What will they think of next to add to the user fee list?

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FDA Finds Fungus in Nasal Solution

Tue, 10/01/2013 - 2:31pm

The U.S. Food and Drug Administration is alerting patients and health care providers that budesonide solution, which is used for nasal irrigation, from The Compounding Shop in St. Petersburg, Fla., may be contaminated and should not be used or administered to patients.

 

FDA observed a 1000 mL bottle of budesonide solution from The Compounding Shop that contained visible, white, floating material. FDA identified that material as a fungus and is concerned that contamination may be present in other budesonide solution products from The Compounding Shop that may currently be on the market.

 

Drug products that are for oral inhalation— such as the budesonide solution from the Compounding Shop, which is labeled “for inhalation only”— are required to be sterile. Contaminated drug products, whether used by inhalation or otherwise, put patients at risk for infection. Patients and health care providers who have this product on hand should not use it.

 

The budesonide solution from the Compounding Shop is also labeled for nasal irrigation, which may be confusing to consumers.

Congress Speaks Up for Community Pharmacies’ Compounding Services Published October 1, 2013

By Kevin Schweers

Three days before today’s government shutdown produced by partisan gridlock, Republicans and Democrats came together to approve drug safety legislation and re-affirm their support for compounding services provided by independent community pharmacies.

On a voice vote, the House of Representatives approved H.R. 3204, The Drug Quality and Security Act, legislation endorsed by NCPA, that responds to the tragic 2012 meningitis outbreak and adopts supply chain protections. The legislation is currently awaiting approval by the Senate. In the debate preceding the vote, lawmakers discussed how the bill protects community pharmacies’ ability to continue to compound drugs for their patients and asserted their intent to monitor its implementation to ensure it does not inadvertently infringe upon long-accepted compounding pharmacy practices.

“Mr. Speaker, this bill upholds the current section 503(a) of the law, and provides it with the clarity that FDA needs by eliminating the unconstitutional provisions,” said House Energy and Commerce Committee Chair Fred Upton (R-Mich.). “The bill also requires FDA to engage in meaningful communication with State boards of pharmacy. Further, under this bill, entities engaged in sterile drug compounding can voluntarily register with FDA and operate under FDA regulation. Finally and importantly, this bill protects traditional pharmacy compounding that occurs in community pharmacies across the country. That’s why the bill has the support of the National Community Pharmacists Association, and I would like to thank them for working with us so closely.”

Health Subcommittee Chair Joe Pitts (R-Penn.) opened his remarks noting that, “First, the bill would protect traditional pharmacies and clarify laws related to human drug compounding in response to last year’s nationwide meningitis outbreak – one of the largest public health crises in recent memory.” He also cited NCPA as one of the bill’s supporters, among other industry groups.

From the Democratic side of the aisle, Health Subcommittee Ranking MemberFrank Pallone (D-N.J.) added that, “The bill will permit compounders who wish to practice outside the scope of traditional pharmacy to register as outsourcing facilities, but those who choose to remain traditional pharmacies will continue to be regulated as they are under current law.”

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HRT Risks May Vary by Type of Estrogen Drug Published: Sep 30, 2013 | Updated: Oct 1, 2013

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From the FDALAW Blog--September 30, 2013 National Rx Track and Trace System Could Soon Be a Reality – House Passes HR 3204 By William T. Koustas & Jessica A. Ritsick –

With California’s electronic pedigree requirement set to take effect in 2015, we have been following recent efforts by Congress to enact a national prescription drug track and trace system (see our previous posts here, here, here, and here).  The House passed a bill in June, H.R. 1919, that would create a national pedigree system and the Senate Committee on Health, Education, Labor, and Pensions (“the Senate Committee”) passed a similar bill, S. 959, in May.  Then, late on September 25, 2013, leaders from the Senate and House committees overseeing health care policy announced that they reached an agreement on bipartisan and bicameral legislation (“bicameral legislation”) that would amend the Federal Food, Drug, and Cosmetic Act (“FDCA”) to address compounding pharmacies and incorporate a national prescription drug track and trace system as well as national standards for prescription drug wholesale distributors (“wholesalers”) and third-party logistics providers (“3PLs”).  The House passed the bicameral legislation, the Drug Quality and Security Act (H.R. 3204), on September 28, 2013 by voice vote.  A detailed outline of the bicameral legislation prepared by Hyman, Phelps & McNamara, P.C. can be found here.

The track and trace system (i.e., pedigree) set forth in the bicameral legislation would preempt state pedigree requirements and eventually create a national interoperable electronic prescription drug track and trace system.  While the bicameral legislation is in many respects similar to the Senate Committee’s bill, it contains some significant differences.

The bicameral legislation provides specific track and trace requirements for manufacturers, wholesalers, repackagers, and dispensers (e.g., pharmacies) of prescription drugs.  Unlike the Senate Committee’s bill, it does not require 3PLs to be responsible for pedigrees.  Under the bicameral legislation, manufacturers would be required to include a product identifier number on each “package and homogeneous case” of prescription drug product they produce within four years of enactment, while repackagers would be required to include it within five years.    In the meantime, the bicameral legislation requires manufacturers, wholesalers, repackagers, to provide and/or receive pedigree by January 1, 2015, while dispensers are required to do so by July 1, 2015.  In addition, wholesalers would be required to accept and distribute only those prescription drug products that include product identifiers within six years, while dispensers would be required to only receive proscription drug products with a product identifier within seven years.  As such, other than for 3PLs, the timelines for incorporating and distributing drug products with a product identifier for manufacturers, wholesalers, dispensers, and repackagers remains unchanged from the earlier Senate Committee’s bill.

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