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Texas Officials Weigh in on Compounding Pharmacy Regulation

David Turnbull3 years ago

Dallas Morning News reports that the U.S. Food and Drug Administration has published warnings to doctors to stop issuing NuVision Pharmacy modified compounded drugs. 

Compounding pharmacies have been under increased scrutiny in recent months, after a meningitis outbreak caused from contaminated steroids from a compounder near Boston, 64 patients in the United States died as a result and hundreds of other patients became sick.

Concerns over compouding pharmacy regulations were further heightened when contaminated IVs from Specialty Compouning near Austin, Texas resulted in blood stream in fections in a number of Corpus Christi patients.

Increased Federal Overreach Upon Drug Manufacturers

  • U.S. Representative Joe Bartion (R), of Arlington, Texas, believes that more federal oversight would have prevented the contamination from the New England Compounding Center that caused the meningitis outbreak.  
  • According to the U.S. Centers for Disease Control and Prevention, the outbreak has been linked to 750 cases of infection and 64 deaths.
  • The International Association of Compounding Pharmacies states that the current bill SB 959 provides “broad and unprecedented power” to the FDA and is not an advocate of the FDA reviewing local pharmacies.

Opposition Believes Federal Standards Do Not Align with Industry Standards

  • The compounding industry, based largely out of Houston, Texas, claims that state regulators including the Texas State Board of Pharmacy are more qualified to review small pharmacies than the FDA. 
  • Furthermore, NuVision president Kristi Kubosh states that the FDA’s standards being used for drug manufacturers are not analogous to the standards used for drug compounders or pharmacies. Of 6,500 pharmacies in Texas, only 600 answered a voluntary survey stating that they were compounders. 
  • The Enforcement Chief for the Texas State Board of Pharmacy, Carol Fisher states that only 100 pharmacies were inspected in 2013 so far, with seven inspectors conducting the reviews. 
  • According to the Ms. Fisher, the State of Texas does not have enough resources to inspect all it’s pharmacies each year due to budget constraints.
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