Tuesday, May 28, 2013
Markey Proposed Federal Legislation v. Senate HELP Committee Version
The two bills are compared in this news article, U.S. lawmaker would give FDA more oversight of drug compounding
Iowa Administrative Code Relating to Pharmacies and Compounding
new link to the code updated as of 5/28/2013 found here
A prolonged stay: The reason behind the slow pace of executions
By Raymond Bonner, special to ProPublica
States that impose the death penalty have been facing a crisis in recent years: They are short on the drugs used in executions.
In California, which has the country's largest death row population, the chief justice of the state supreme court has said there are unlikely to be any executions for three years, in part due to the shortage of appropriate lethal drugs. As a result, state prosecutors are calling for a return of the gas chamber.
Ohio, which is second only to Texas in the number of executions carried out since 2010, said it will run out of the drug it uses in executions, pentobarbital, on Sept. 30. The state has two men scheduled for execution in November, and eight more set to be killed after that. Every state's supply of pentotbarbital, which has been the principal execution drug, expires at the end of November.
The shortage has forced death penalty states to scramble on two fronts: They are hunting for new suppliers or different drugs to use, and enacting changes to public records laws to keep the names of suppliers and manufacturers of those alternative drugs secret.
continue to read here
A Day in the Life of this Blog: Where The Blog Is At Today
The blog has now reached over 127,000 views. The blog is close to having folks in 100 countries reading it. And soon the 4000th blog entry will be added. The blog has been called the "gold standard" in compounding resources. Pharmacy board members have written to tell me they suggest all the board members read the blog and some have implemented some of the suggested changes such as adding people other than pharmacists to their boards.
Congressional Consensus on Compounding Reform Stuck in Neutral After three hearings on the pressing issue, House lawmakers have not reached a consensus on how to reform federal oversight of compounding pharmacies, casting doubt on whether Congress will be able to pass legislation the FDA says it wants. Drug Industry Daily
read more here
A NEW SPIN ON THE PROPOSED LEGISLATION--MUST READ: Proposed legislation compounds pharmacy risks If passed, the bill to reform compounding medicines could create opportunities to some pharmacies. By AlphaVN.com 9 hours ago
The pharmacy industry is likely to undergo a number of changes over the next few years with the implementation of the Affordable Care Act. The industry has had to deal with a number of major legal issues surrounding prescription security for opioids like Oxycontin. This issue has still not been fully addressed. Another issue relates to compounded medicines.
Just last week news broke of yet another contamination scare of compounded steroids made at a pharmacy in Tennessee that sickened patients. Last year, a breakout of fungal meningitis was linked to the same compounded steroid. And now, a bill to change compounding practices is heading to the Senate floor. This could create risks as well as opportunities to companies in the industry.
Pharmaceutical compounding is the customization of medications to fit a particular patient's needs. These meds, often manufactured by compounding companies on which the U.S. Food and Drug Administration has only limited oversight.
All of the major pharmacy chains like Walgreen (WAG -1.06%) and CVS Caremark (CVS +1.71%) offer compounding services. Walgreen recently inked a partnership with major drug compounding companyAmeriSourceBergen (ABC -0.13%) in what looks like a move that anticipates these legislative changes. Walgreens Specialty Pharmacy, LLC. is a subsidiary of Walgreen that carries out this part of the business. It generated $419 million in revenue in 2012.
The proposed legislation, which has made it out of the Senate committee, is up for a vote some time this summer. The bill will expand the FDA's oversight of the entire compounding supply chain and likely result in the closing of a number of small compounding pharmacies. Legislation like this, if passed by Congress, will almost certainly raise the costs of compounding. Larger companies like Walgreen will benefit directly from these changes in a classic barrier to entry effect, further rolling up revenue of prescription drug distribution to large chain pharmacies and away from independent ones.
Between this scare over quality of compounding medicines and the increased need for prescription chain-of-custody security for highly-demanded street drugs, pharmacies, especially independent ones, will have to specialize if they want to find opportunities for growth as the major chains move into more traditional roles of community or local pharmacies.
The effect of the proposed compounding legislation and other drug-oversight legislation at the state level will create new niches for pharmacies to fill and from which to build client lists. For niches like these it makes more sense for the major players to partner with local service providers rather than compete directly with them. However, we see this drive to greater legislative oversight continuing, and the risks associated with that for small companies quite high.
quoted from here
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