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
Sunday, June 29, 2014
Saturday, June 28, 2014
Sixth Question of the Day June 28, 2014 Aren't compounding pharmacies, pharmacists and organizations that represent them makeing a very good argument that the FDA should be given total authority over all compounding so that there will be no confusion as they claim still exist? Concurrent jurisdiction with state boards of pharmacy just as criminal illegal drugs are now regulated?
Texas Board of Pharmacy Proposed Rules--Still time to Comment by July 31, 2014
Proposed Rules by the Texas State Board of PharmacyOn June 13, the Texas State Board of Pharmacy proposed rules in seven areas of regulations which, if adopted, will impact pharmacies, pharmacists and pharmacy technicians. Below are excerpts of the rules along with page references from the Texas Register. Click here if you wish to access the actual, detailed set of the proposed rules as published in the Register. TPA will be submitting a comment letter on these proposed rules and will provide the Association’s membership with an analysis of the rules in the next two weeks prior to the July 31 comment deadline.
ØConcerning pharmacy license fees. The rule will decrease pharmacist license fees based on expected expenses. (page 39 TexReg 4596)
ØConcerning definitions; personnel; operational standards; and records for Class A (community) pharmacies. The rules update the reference to advance practice registered nurses; clarify that the requirements for dispensing a prescription are the same for a pharmacist and for an intern and eliminate references to sterile compounding that are no longer necessary. The rules also eliminate the requirement for the pharmacist to notify the prescriber of a substitution of dosage form.(page 39 TexReg 4597)
ØConcerning Class C (institutional) pharmacies located in a freestanding ambulatory surgical center. The rules clarify the labeling requirements for medications provided by ASC pharmacies; remove references to sterile compounding that are no longer necessary; and add tramadol to the record keeping requirements to be consistent with other sections.(page 39 TexReg 4602)
ØConcerning pharmacies compounding sterile preparations. The proposed rules clarify the training requirements for pharmacy technicians in American Society of Health-System Pharmacists accredited programs. (page 39 TexReg 4604)
ØConcerning Class F pharmacies, which are pharmacies located in a freestanding emergency medical care center. The rules clarify the labeling requirements for medications provided by Class F pharmacies; remove references to sterile compounding that are no longer necessary; and add tramadol to the record keeping requirements to be consistent with other sections.(page 39 TexReg 4605)
ØConcerning pharmacist license or renewal fees. The rules will decrease pharmacist license fees based on expected expenses.(page 39 TexReg 4607)
ØConcerning fees. The rules will decrease pharmacy technician and pharmacy technician trainee fees based on expected expenses.(page 39 TexReg 4608)
Comments on these proposed rules should be submitted to Allison Benz, R.Ph., M.S., Director of Professional Services, Texas State Board of Pharmacy, 333 Guadalupe Street, Suite 3-600, Austin, Texas 78701, fax (512) 305-8008. Comments must be received by 5:00 p.m., July 31, 2014.
Click Here to View Proposed RulesComments on these proposed rules should be submitted to Allison Benz, R.Ph., M.S., Director of Professional Services, Texas State Board of Pharmacy, 333 Guadalupe Street, Suite 3-600, Austin, Texas 78701, fax (512) 305-8008. Comments must be received by 5:00 p.m., July 31, 2014.
Texas Pharmacy Association Conference and Expo June 30--
LAST CHANCE for Advance Registration: Cut-off for the 2014 TPA Conference & Expo is June 30th | ||||||||
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Fifth Question of the Day June 28, 2014 If OTC acne medications are causing heath problems and risks, what about all the compounded acne treatments and skin care products that compounding pharmacies are making? And why aren't companies with patents bringing patent infringements?
This is a photo of a Blemish Blaster Acne Wash that a local compounding pharmacy makes. Interestingly, a pharmacy tech mixed it up in less than 30 minutes and promised it was the equivalent to what Proactive makes and includes the same ingredients. In fact, the compounding pharmacy has an entire line of acne products it compounds. The first question is what about Proactive's patent. The second question is with the recent FDA alert regarding acne treatments what is the harm being done by all the compounded skin care treatments, especially acne treatments.
The Drug Shortage Report: Shortage of Saline Has Hospitals on Edge --Salty Water Harder to Make Than One Might Think
Hospitals across the country are struggling to deal with a shortage of one of their essential medical supplies. Manufacturers are rationing saline -- a product used all over the hospital to clean wounds, mix medications, and treat dehydration. Now drug companies say they won't be able to catch up with demand until next year.
That leaves San Francisco General Hospital's materials manager, Reid Kennedy, in a fix. Kennedy is in charge of managing all the gloves, bandages, bedpans, and IV solutions for all the medical floors, emergency room, and operating room.
He first got a call last year from his vendor telling him they might not be able to deliver his full order.
"We were put on notice that it was going to be tight," he said.
Then things got worse in January. The flu season hit much harder than expected, and sick people flooded into hospitals. Saline bags flew off the shelves to treat dehydration, and demand far outstripped supply.
"The flu season knocked us out as an industry," Kennedy said. Though hospital administrators say the shortage hasn't affected the quality of patient care, Kennedy uses the word "crisis" to describe the shortage.
It's Harder to Make Than You Think
But can salty water really be that hard to come by? Kennedy pays $1.57 per bag. Why can't drug companies just whip up some more?
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