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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US Senator Bennet Joins HELP Committee Colleagues Calling for Senate Passage of Drug Quality and Security Act

Bennet’s Bipartisan Track-and-Trace Bill Included in Proposal

September 30, 2013

Colorado U.S. Senator Michael Bennet joined a bipartisan group of Senate Health, Education, Labor, and Pensions (HELP) Committee senators to applaud the House passage of a bill to track all prescription drugs from the point they are manufactured to the drug store and to provide better oversight of compounding pharmacies.  The senators urged their colleagues to pass a companion measure that passed the House of Representatives on Saturday.

The Drug Quality and Security Act reflects a bicameral, bipartisan effort to address these drug safety and security issues.  The drug supply chain security provisions are based off of Bennet’s Drug Supply Chain Security Act he introduced with Senator Richard Burr (R-NC) in May after working to find consensus over the last two years. The last comprehensive effort to establish safeguards for the drug distribution supply chain was 25 years ago with the passage of the Prescription Drug Marketing Act.

In addition to Senator Bennet, the bill was introduced by HELP Committee Chairman Tom Harkin (D-IA), Ranking Member Lamar Alexander (R-TN), and Senators Al Franken (D-MN), Pat Roberts (R-KS), and Burr.

“If fruit growers in Colorado can track a peach from the tree to the grocery store, we should be able to monitor prescription drugs in a similar way,” Bennet said.  “Whether it is through a stronger supply chain or better oversight for compounded drugs, this commonsense bill will help restore confidence in our prescription drugs and protect our families from any potential health risks.  Now that the House has passed this bill, we will work to get it passed quickly in the Senate and sent to the President for his signature.”

Drug Supply Chain Security

Sen. Bennet, Sen. Burr, Chairman Harkin, and Ranking Member Alexander, have developed track and trace legislation that improves patient safety by replacing today’s patchwork of state product tracing laws with a strong, uniform standard that would ultimately result in electronic, interoperable unit level product tracing for the entire country.  This bipartisan, bicameral draft is the result of several years of work to address the growing problem of pharmaceutical theft, counterfeiting, and diversion.

Among other highlights, the legislation:

• Develops a workable pathway to unit-level tracing in a decade. Over the course of seven years, the major sectors of the pharmaceutical supply chain, such as manufacturers, repackagers, wholesale distributors, and dispensers will all be passing and holding onto key information about each drug’s distribution history.  Within ten years, supply chain stakeholders will participate in electronic, interoperable product tracing.
• Strengthens licensure requirements for wholesale distributors and third-party logistics providers.  Wholesale distributors will have higher standards for their licenses nationwide, and third-party logistics providers will be recognized for the first time as a part of the drug supply chain. FDA will also keep a database of wholesalers that will be available to the public through the FDA’s website, allowing consumers and members of the drug supply chain to identify appropriately licensed wholesalers.
• Establishes nationwide drug serial numbers.  Four years after the date of enactment, manufacturers will serialize drugs in a consistent way across the industry.  This will allow for efficient tracing to respond to recalls and notices of theft and counterfeiting.

Compounding Oversight

One year ago, the meningitis outbreak caused by contaminated compounded drugs from the New England Compounding Center alerted the nation that providers and patients need sources of safe compounded drugs.  Following the outbreak, a bipartisan group of HELP Committee Senators— led by Chairman Harkin, Ranking Member Alexander, Sen. Franken, and Sen. Roberts—developed legislation to help ensure that quality compounded drugs are available to patients who need them.

Among other highlights, the legislation:

• Distinguishes compounders engaged in traditional pharmacy practice from those making large volumes of compounded drugs without individual prescriptions. Compounders who wish to practice outside the scope of traditional pharmacy practice can register as outsourcing facilities, but those who choose to remain traditional pharmacies will continue to be primarily regulated by State Boards of Pharmacy as they are in current law.
• Defines the Food and Drug Administration’s (FDA’s) role in oversight of outsourcing facilities.  Outsourcing facilities would be subject to FDA oversight in much the same way as traditional manufacturers.  FDA will know who these outsourcers are and what they are making, receive adverse event reports about compounded drugs, and have the authority and resources to conduct risk-based inspections.  The legislation will give providers and patients the option of purchasing product from outsourcing facilities that comply with FDA quality standards.
• Offers providers and patients better information about compounded drugs.  The legislation directs FDA to make a list of FDA-regulated outsourcing facilities available on FDA’s website, requires detailed labeling on compounded drugs, and prohibits false and misleading advertising.
• Clarifies current federal law regarding pharmacy compounding.  The legislation strikes unconstitutional provisions in current law, resolving the patchwork of current federal regulation and applying a uniform standard nationwide.

Question of the Day October 1, 2013, Is anyone including Congress, the FDA, and State Boards of Pharmacy, paying attention to what is going on in the compounding pain medication world? The discussion on CafePharma board is very telling.

ny pain reps looking to make 10K to 40K per month on the side?

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With all the connections you Pfizer reps have and are paid so little in comparison to the huge revenue I was just wondering if any of you would be interested in earning an extra 10K to 40K per month? Our company not only has a compounding pharmacy that you can promote but also 2 additional services that our reps promote with one being the industry leader in Genetic DNA testing via oral swab. The need for personalized medicine is growing rapidly and physicians are looking for genetic help to pick which medication is right or wrong for a patient and what dose they should start them on. The third service is a drug testing confirmation lab.
The real money maker for most reps in the compounding pharmacy which is why the industry is exploding right now. Everyone has seen Voltaren Gel promoted in your offices and it only has one active ingredient which is Diclofenac with a 1% concentration. Our pharmacy combines an NSIAD like Diclofenac but with at least a 3% concentration along with many other active ingredients to offer a product that typically offers much better pain reduction and is applicable to many more conditions and patients. Doesn't it make perfect sense that if you take that NSAID along with a muscle relaxer, a neuropathic pain med like Gabapentin, and throw in a topical anesthetic that you could treat a wide range of pain patients? Considering that we have meds to treat wounds and scar and that the aver reimbursement is around $1,800 per script and a rep earning 20% to 24% commission you can see why we had a rep work 4 hours in their first week working just Thursday & Friday and earned $2,500 off of 3 physicians. When they went back on Monday the physician had already written 7 new scripts so they could easily end up earning about 11K this week. If you consider that we pay a commission on every scripts whether it is a new RX or a refill you can see why reps are earning 10K to 40K per month. If you can find 20 physicians to write just 1 script per week you should earn about 28K per month. Keep in mind that those do not have to be new scripts, that could be 10 physicians who wrote 1 script per week last month and those patients got refills and you are right back at 20 scripts per week. When you factor how many scripts you might get in the third month you see why this is so attractive. You are a 1099 rep which means you are your own boss with no reports to turn in, no one micromanaging you, you can be at the beach every day and never make another sales call but if your physicians keep sending in scripts we keep paying you month after month year after year. Let's just say that there are a lot of reps both pharmaceutical and medical device that are finally jumping up in the morning excited about going to work as they finally are getting to work for themselves. Big pharma always talks about taking ownership and running the territory like you own it but they never pay you like you own it. You never have any quotas or sales number to hit and it’s the best residual income you will ever earn. The biggest hurdle reps have it getting past their concern that this is real and not some scam but it doesn't take much research to find out this industry is exploding. If you are interested you can go to our website at www dot SupremeMedSolutions dot com or you can email me at tisley at chartertn dot net. We offer the highest commission in the industry and multiple products you can sell and earn that high residual income on. What have you got to lose in finding out a little more info?

Quoted from CafePharma Board found here

DeGette Lauds House Passage of Compounding Drug Bill

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Editorial: Put teeth back in compounding pharmacy bill-If it walks like “big pharma,” it ought to be regulated like “big pharma.”

By South Jersey Times 
on October 01, 2013 at 5:30 AM, updated October 01, 2013 at 5:37 AM

Amid the weekend jockeying to avoid a federal government shutdown over “Obamacare,” and the eve of the health care law’s enrollment period, lawmakers didn’t completely forget another medical issue.
Saturday’s otherwise unproductive House sessionresulted in passage of a bill for more oversight of “compounding pharmacies” — one of which was said to have caused 750 cases of fungal meningitis last fall and winter, including dozens in New Jersey. Some 64 people died nationwide.
The measure passed on a voice vote. But, it’s only a half a loaf. It would let compounding pharmacies register for voluntary regulation under the U.S. Food and Drug Administration.
These pharmacies are not your corner apothecary or national drugstore chain outlet. They make what is supposed to be customized, low-volume medication that the pharmaceutical giants won’t touch. Compounding pharmacies are necessary, but some are functioning just like the drug giants under full FDA regulation, manufacturing thousands of doses of certain items.
The sites are subject to spotty state licensing and inspection. It was just such a compounding pharmacy, the New England Compounding Center in Massachusetts, that Centers for Disease Control investigators say delivered steroid pain injections that were tainted with the dangerous and sometimes deadly fungus.
In South Jersey, the medicine was administered through sites such as Premier Orthopedic Associates in Vineland and South Jersey Healthcare’s Elmer and Vineland hospitals, now Inspira. Some 48 patients throughout New Jersey had tested positive for fungal meningitis as of January, state officials reported.
Large compounding pharmacies need more than a prod toward voluntary inspection. This watered-down bill now moves to the Senate. Lawmakers don’t want to over-regulate small compounders, but it shouldn’t be hard to separate them from these under-the-radar drug makers who can now get away with shipping thousands of doses made in filthy conditions.
If it walks like “big pharma,” it ought to be regulated like “big pharma.”
quoted from here

National Association of Board of Pharmacies October 2013 Newsletter Now Available--several compounding issues discussed

here