This interesting article by Ms. Johnson, the Globe's only science reporter, deserves a follow-up from a reporter knowledgable about government regulation, which the Globe lacks. Going forward, a critical issue arising from the recent medical disaster will be how to prevent another one. --
-------------------------------------------------------------------------------------------------- It's not likely to be nearly as simple as some readers seem to imagine. The FDA has been concerned about so-called "pharmacy compounding" for over 20 years. It issued a "guide" in 1992. [ Manufacture, distribution and promotion of adulterated, misbranded, or unapproved new drugs for human use by state-licensed pharmacies, FDA Compliance Policy Guide 7132.16, May, 1992 ] --
-------------------------------------------------------------------------------------------------- The 1992 guide tried to set limits on "pharmacy compounding" but failed to define a key element, "inordinate amounts"--supposed to differentiate between manufacturing and compounding. Another undefined key element to identify manufacturing was "soliciting business...to compound specific drug products." --
-------------------------------------------------------------------------------------------------- Responding to those concerns Congress enacted, as part of the FDA Modernization Act of 1997, Section 127 of the Act on pharmacy compounding. It exempted compounding by a licensed pharmacy or physician from FDA regulation when a "drug product is compounded for an identified individual patient based on the unsolicited receipt of a valid prescription order," together with other restrictions. --
-------------------------------------------------------------------------------------------------- Among the other restrictions was that "the pharmacy, licensed pharmacist, or licensed physician does not advertise or promote the compounding of any particular drug, class of drug, or type of drug." That was challenged by a group of compounding pharmacies. Based on First Amendment rights, the Supreme Court sided with the pharmacies, invalidating all of Section 127. [ Thompson v. Western States Medical Center, Supreme Court No. 01-344, 535 U.S. 357, decided April 29, 2002] --
-------------------------------------------------------------------------------------------------- Following the Supreme Court ruling, the FDA issued a new "guide" describing limits on pharmacy compounding, still in effect. Similar to the 1992 guide, it uses undefined terms "small quantities" and "commercial scale manufacturing" instead of "inordinate amounts." However, it does not mention prescriptions for "identified patients" or "soliciting business." [ Pharmacy Compounding, FDA Compliance Policy Guide 460.200, 2002, at http://www.fda.gov/OHRMS/DOCKETS/98fr/02D-0242_gdl0001.pdf ] --
-------------------------------------------------------------------------------------------------- Federal regulation of pharmacy compounding is no more capable of preventing another disaster now than it was 20 years ago. Indeed, shortly after the current FDA guide was issued in May, 2002, a disaster similar to the recent one occurred. At least five patients were poisoned by doses of the same injectible steroid drug, made by the former Urgent Care Pharmacy of Spartanburg, South Carolina, and contaminated by a fungus. [ Nationwide Alert Regarding Injectable Drugs Prepared by Urgent Care Pharmacy, FDA, November, 2002, at http://www.fda.gov/ICECI/EnforcementActions/EnforcementStory/EnforcementStoryArchive/ucm095793.htm ]

Excellent article, Carolyn (and comment, Bolons). I suspect that the solution for how to effectively and efficiently regulate compounding pharmacy product safety is fairly obvious for those in the know. That solution just needs to be given a higher priority than profit (this is not rocket science, after all). Time for Congress to step up.

What other areas involving patient safety have inspections that are not unannounced?

I heard a pithy comment the other day about the economic situations in Europe and the US and I'd guess that it applies here. The comment was that, to foster growth: "Europe has the will but not the ways, while the US has the ways but not the will".

By the way, how do those in other states where people are infected or have died feel now about state regulation of compounding pharmacies? Do you feel comfortable about assuming the risk that the potentially more mom-and-pop regulation environment in another state might put your own residents at risk? Or do you want to change the rules and allow only in-state compounding pharmacies to supply state needs?

Under the activist direction of Dr. Margaret Hamburg, during the Obama administration, FDA has increased its efforts to regulate pharmacy compounding--so far with little to show for them. In April, 2010, FDA sought to enjoin Franck's Lab, a compounding pharmacy in Ocala, FL, from preparing drugs for animal use from "bulk substances." In a carefully researched decision, District Judge Timothy J. Corrigan denied the injunction, finding that FDA lacked statutory authority to prohibit compounding from "bulk substances." --
-------------------------------------------------------------------------------------------------- [ United States v. Franck's Lab, U.S. District Court for Florida central district, 816 F. Supp. 2d 1209, decided September 12, 2011, available at http://legaltimes.typepad.com/files/francks_opinion.pdf ] --
-------------------------------------------------------------------------------------------------- This was the first and, so far, the only time since enactment of the Federal Food, Drug and Cosmetic Act of 1938 that FDA has moved to shut down operations of a compounding pharmacy. FDA was surely embarassed by rejection of its fundamental authority. Since then, Franck's Lab was the target of an FDA recall, for fungal contamination in a drug distributed to opthalmologists. Mr. Franck, its owner, subsequently sold business assets to Wells Pharmacy Network of Wellington, FL. FDA is using that event as justification to dismiss the case, but its real motive is probably to avoid creating a legal precedent from a badly constructed case that could undermine FDA regulation. --
-------------------------------------------------------------------------------------------------- [ Opthalmology Times, FDA recalls Brilliant Blue G, Modern Medicine, March 28, 2012, at http://www.modernmedicine.com/modernmedicine/ModernMedicine+Now/FDA-recalls-Brilliant-Blue-G/ArticleStandard/Article/detail/766307 ] --
-------------------------------------------------------------------------------------------------- [ Motion to dismiss, U.S. District Court for Florida central district, filed October 16, 2012, to be argued November 1, 2012, available at http://www.hpm.com/pdf/blog/Francks%20Motion%20to%20Dismiss%20Appeal.pdf ]