Unanimous Consent is a procedure prevents any debate, prohibits amendments, and no Senator is forced to go on the record and affirmatively support the bill. The Senate Website does not currently have the bill listed for consideration next Monday but rumors are that is when it may be considered. At least one U.S. Senator, Tom Colburn from Oklahoma, has indicated he will not agree to unanimous consent of the bill. Stay tuned to the blog for more information.
Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Tuesday, July 30, 2013
National Community Pharmacists Association, which claims the proposed legislation is anti-pharmacy
Pharmacists Group Lobbies Against Senate Compounding Bill
Yet another professional organization has found reason to object to the compounding bill moving through the US Senate. The latest group hoping to block its passage is the National Community Pharmacists Association, which claims the proposed legislation is anti-pharmacy and is relying on a parliamentary continue to read here
Imprimis Pharmaceuticals Innovates Back to Basics With Compounding
CHICAGO(TheStreet) -- Although the number of people needing custom medicines and new ways to take them is growing exponentially, there are few pharmaceuticals companies positioned to take advantage of the trend.
The California company has a unique combination of delivery methods and partner that make it worthy of attention as more people worry about the harmful long-term effects of certain mass-produced medications.
For instance, nonsteroidal anti-inflammatory drugs such as Advil, Motrin and Aleve have been shown in studies to cause stomach ailments. "Gastritis, esophageal reflux disease and bleeding ulcers are all problems that can develop from NSAIDs," says Robert Hoffman, chief of rheumatology at the University of Miami's Miller School of Medicine.
Such mass-produced drugs have developed into a multibillion-dollar industry since industrialization became the norm in the 1950s. Imprimis CEO Mark Baum looks to the era before that, though, when it was common for pharmacists to blend custom prescriptions for individual customers. He thinks his company can make strides to revolutionize modern drug compounding, improving their quality and moving them swiftly through Food and Drug Administration approvals.
Imprimis has a drug delivery technology that ensures site-specific treatment via a topical cream preparation, including with Impracor, a drug entering Phase 3 approvals from the FDA in the third quarter of 2013, and a variety of others that "will enable the delivery of drugs intravenously... as well as through the mouth, through the nose, and trans-vaginally, which gives us the ability... to affect men's health, women's health, as well as [avoid] gastrointestinal conditions," Baum says.
The technology could revolutionize the way pharmaceuticals, especially analgesics, are accessed and administered, Baum says.
Imprimis already uses its Transdel technology to deliver an NSAID called ketoprofen via a cream that is rubbed on the skin, where it acts on the underlying tissues to ease pain.
Imprimis' partner in the revolution is the Professional Compounding Centers of America, "the largest player in the compounding pharmacy industry in North America," Baum says. "The PCCA has over 10,000 proprietary compounded drug formulations and ... more than a dozen proprietary drug delivery technologies," and Imprimis has an exclusive relationship with the PCCA to develop and commercialize its library of patented formulations and technologies -- to mine the library for drugs that can be developed internally or through a development partner.
This library has the potential to provide Imprimis with multiple large-market drug candidates annually, Baum says, saving cost and time. Since all the formulations have been used by the PCCA's patients, ample data are available on their performance and safety that Imprimis can use in putting drugs through the federal 505(b)(2) approval pathway.
"These are drug formulations that are typically sold by ... compounded pharmacies all over the country. Imprimis is taking them through a traditional regulated FDA process in order to bring them to the market," Baum says.
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