Whats the difference between a Compounder and a Manufacturer? A Prescription Silly! hhahahha The FDA didn’t seem to get this one!
Purpose The purpose of this site is to raise both awareness and funds to support the legal struggle against the Food and drug Administration. Ten pharmacies joined together in September 2004 and sued the FDA in Federal Court in Midland Texas. This action was forced by the FDA’s stated thoughts, ambiguous enforcement and downright hostile inspections. Unless we stand up and fight for our rights the FDA (and Big Pharma) will continue to assert that all compounding is illegal. This is our best chance to finally put an end to the FDA’s hostile actions toward compounding. Please show your support by making a financial contribution today.
The FDA’s unrestrained inspections are specifically prohibited by statute under 21 USC 374(a)(2)(A).State Boards of Pharmacies are charged with the oversight of State Licensed Pharmacies. If FDA wants to inspect they must work through state boards.
That FDA”s position that all compounds are essentially “new drugs” and thereby being produced illegally is categorically false.Again, 21USC clearly states that compounding custom preparations is legal and goes on define what a new drug is.
Compounding from Bulk Active Ingredients for non food animals is okay.We contend this is merely a tactic used by FDA to limit a Veterinarians options to only branded drugs.
The Compliance Policy Guide which the FDA relies on for enforcement action was created without the proper input from industry as required by their own rules making guidelines. This CPG therefore cannot be mandated.The FDA admits that this is only a guideline and not law but they think we should be forced to follow it anyway.
We would like to thank Terry Scarborough, our lead attorney and his associate on the suit, Matthew T. Slimp for their hard work and dedication to this case. This Coalition (and all compounders) are fortunate to have a legal team with the skill, knowledge and energy this team has demonstrated.
We would also like to recognize the briefs presented by IACP and AAPS on behalf of the Midland Coalition. They were able to offer an outside perspective that undoubtedly carried sway with the Judge Junell in his most recent rulings. Thanks for going through the effort and expense of helping us earn this historic victory. We look forward to working closely together in the many battles that lay ahead.
The Cost To date, the ten pharmacies, at great sacrifice, have paid out almost one million dollars in attorneys and expert witness fees. We have paid the Hance Scarborough Law Firm over $410,000 and the Duane Morris Law Firm more than $540,000 and $40,000 to expert witnesses. We are about halfway through the fight and now that we have proven we can win, please donate what you can to keep the fight going.
