Friday, November 23, 2012
Exemed Pharmaceuticals to buy UCB Indian production facility
Published 23 November 2012
India-based Exemed Pharmaceuticals, a manufacturer of active ingredients, is planning to buy UCB's production facility in Vapi, Gujarat, India.
The deal, which is in line with UCB's strategy on bringing new drugs to patients and less on mass manufacturing, includes a multi-year supply agreement between both the companies.
The Vapi plant, upon completion of acquisition, will focus on the production, packaging and distribution of some of UCB's mature drugs for the Indian market.
In addition to the acquisition which brings long-term growth prospects, Exemed is planning to bring new business to the site.
The financial details of the deal have not been disclosed.
Source found here
Close gaps in drug regulation
2:47 AM, Nov 23, 2012
In a time of sharp resentment toward government regulation in this country, the meningitis outbreak that has hit Tennessee and other states with devastating force provides a clear example that there are cases in which strong and comprehensive oversight of industry is absolutely vital.
A report by The Tennessean published Nov. 18 detailed how Colorado state inspectors knew of problems with New England Compounding Center’s interstate business practices in 2011. While they notified the U.S. Food and Drug Administration, neither the FDA nor (until a year later) the Colorado officials spoke to the Massachusetts Board of Registration in Pharmacy, which licensed NECC and presumably would have taken action against the drug compounder quickly.
Why the lapse in what would seem to be a logical chain of communication? According to a spokeswoman for the Colorado regulatory board, “We historically have not reported actions to other state boards, because in most states the registrants are required to report the actions (themselves).”
Amazing. And yet, all too common. In America, we expect oil companies to self-report about carelessness that could lead to spills, and banks to self-report when improper lending practices have been detected.
Expect the logical extension of this brand of thinking soon: In future, armed robbers must turn themselves in to authorities, or else face a stern reprimand. Police forces could be cut by half.
So far, 13 people have died and 82 been sickened in Tennessee, and 34 dead and 490 sickened nationwide, because NECC was able to continue manufacturing and shipping contaminated drugs though individual state and federal authorities were aware of problems with the company. Those numbers are expected to grow, as health officials continue to find potentially dangerous injection-site infections.
But at least there is no onerous government regulation of the drug-compounding industry.
It is hard to imagine that anyone who works in health care ever thought self-reporting was a good idea. The decision-makers at NECC had two goals: make money, and don’t get caught. Self-reporting? That would be counterproductive.
Those who argue so loudly for across-the-board deregulation should have to sit down for a talk with someone whose husband, wife or child received a steroidal injection for back pain, only to develop deadly fungal meningitis.
Afterward, perhaps they would join this newspaper in calling for Congress to establish a national data center for information on disciplinary actions involving licensed pharmacies, with requirements that state pharmacy inspectors communicate not only with the FDA, but with pharmacy boards in states where the cited company has operations.
It is not regulators who committed these crimes of malice or negligence; it was the drug makers. But we cannot waste any more lives while we wait for them to police themselves.
Source found here
CDC to release new report on meningitis outbreak
The CDC is set to release a new report on the fungal meningitis outbreak.
The death toll continues to climb with the latest deaths coming out of Michigan and Indiana.
The Michigan Department of Community Health said two more people have died bringing the death toll to 10 and a sixth person has died in Indiana.
Source found here
Current Version of Statute and Regulations in Arkansas Board of Pharmacy
to view the November 2012 version click here
Dispensing Drugs, Manufacturing Drugs, and Compounding Drugs
Question
What is a compounding pharmacy and how is it regulated?
| Response from James L. Lindon, PharmD, PhD, JD Director, Pharmacy Law and Intellectual Property, Lindon & Lindon, LLC |
It is easy to differentiate between your local community pharmacy and a large pharmaceutical manufacturer. The pharmacy is viewed as dispensing medications to particular patients with prescriptions from a licensed provider. In contrast, the pharmaceutical manufacturer makes large batches of drug products to be distributed to pharmacy hospitals and other resellers and users of these products.
But there is another entity that falls between these: the compounding pharmacy. To be more precise, the distinctions may best be understood as different types of activities -- dispensing drugs, manufacturing drugs, and compounding drugs -- rather than merely different types of businesses. A pharmacy, which is considered a terminal distributor of dangerous drugs, may be actively dispensing, manufacturing, and compounding.
To understand why we have compounding by pharmacies, we should first understand some of the problems that patients encounter when getting prescription medications. Consider that a patient may need, for example, 15 mg of a particular medication to treat a condition. The pharmaceutical manufacturer of the medication may make only 10-mg and 20-mg tablets. To obtain a 15-mg dose, the patient may buy 10-mg tablets, cut them in half, and take 3 of the halved (5 mg) tablets. Although the math works out just fine, many patients resist this approach; they may not want to cut tablets in half or may not be able to cut tablets in half. Furthermore, splitting tablets can lead to imprecise dosing.
So, why doesn’t the pharmaceutical manufacturer make a 15-mg tablet? One reason may be money. Although a few patients may require a 15-mg dose, most patients may be treated just fine with a 10-mg or 20-mg dose; there may simply not be enough demand to justify mass production of a 15-mg tablet. At some point, the manufacturer has to draw the proverbial line and produce those products and doses that make economic sense to them.
Seeing this as an opportunity, a compounding pharmacy may begin to prepare the 15-mg tablets -- and do so in a profitable manner which the manufacturer could not or would not do. To use another example, a compounding pharmacy may prepare medications without a particular ingredient to which some patients are allergic, such as coloring agents and dyes. Without the compounding pharmacy, some patients may find themselves "stranded" and unable to obtain the medications they need.
Who Regulates Compounding by Pharmacies?
State boards of pharmacy typically regulate compounding by pharmacies, but federal legislation also plays a role. In the state of Ohio, for example, compounding is defined as preparation, mixing, assembling, packaging, and labeling of 1 or more drugs pursuant to a prescription issued by a licensed health professional authorized to prescribe drugs. [1,2]
Ohio state law also allows compounding in anticipation of orders for drugs pursuant to prescriptions based on routine regularly observed dispensing patterns. This means that a pharmacist may compound medications even though the pharmacist does not yet have a written prescription in hand for those medications, provided that the pharmacist reasonably anticipates receiving prescriptions in the future. This allows the pharmacist to make batches of medications. This is important because compounding can require significant amounts of time to complete and it may be difficult to make very small quantities of particular medications. Under Ohio law, a pharmacy may not sell a compounded drug to another pharmacy or a wholesaler. In Ohio, compounded drug preparations must be assigned beyond-use dates that are based on stability and sterility. [1,2]
State boards of pharmacy can and do enforce regulations pertaining to pharmaceutical compounding. For example, in 2006, the Ohio State Board of Pharmacy took action against Home Medical Enhancement Services, Inc. [3] The Board alleged that the company prepared subpotent medications and did not properly sterilize some compounded medications. The Board alleged that there was fungal contamination in some of the company's pulmonary products. State boards of pharmacy also can and do promulgate and enforce sterile compounding standards. [4]
Renewed Regulatory Interest
The matter of regulating compounding pharmacies (or compounding by pharmacies) and manufacturers recently gained renewed attention when an operation in Massachusetts allegedly prepared and distributed corticosteroids that were administered to patients who subsequently developed serious fungal infections. Some of these patients died. According to reports from the Centers for Disease Control and Prevention, the New England Compounding Center and its sister company Ameridose were involved in the production and eventual recall of methylprednisolone acetate (MPA) and other products in September 2012. [5] The methylprednisolone was particularly prone to sterility concerns because it was produced without antimicrobial preservatives, a common practice for medications injected into the fluid of the central nervous system.
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