They didn't like the answer the FDA provided. If they go to court on the issue and win, Congress or states could turn around and pass very clear legislation overruling the case law and prohibiting office use unless compounds come from an outsourcing facility and they could make it apply to veterinary compounds. If they go to court and lose, they will have no arguments left. I don't see the majority of Congress amending the DQSA because it would make the outsourcing provisions meaningless. If Congress is going to amend it will be to include veterinary compounds in the DQSA or to give the FDA even more authority in light of more and more bad inspections, more and more information coming out showing the dangers of compounded medications and the lack of potency, fraud and abuse etc. in the industry. It will be interesting to see what IACP's next move is. I wonder if they have ever thought their next move should be compliance with the laws and clearning up the industry gone bad- rather than continuing down the same path. That might go along way toward fixing the bad reputation and image of compounding pharmacists. I don't see it happening, however, because of greed and the amount of huge profits compounding pharmacists stand to lose if they actually follow the law and do what is right.
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Where medically necessary, a compounded drug intended for use in an office setting can and should be prescription-based; purchase-order-like transactions involving compounded, unapproved new drugs should be expressly forbidden.
Because compounded drug formulas are sold or otherwise made available without guarantee, and because components, including brokered, purchased, and repackaged active and inactive pharmaceutical ingredients are also sold without guarantee, the prescription is the foundation where fitness for intended use is constructed. This is not a trivial undertaking, given lack of scientific rigor backing formulas in conjunction with the current state of global supply chain security for chemicals reaching the U.S.
Where a medical decision to use an unapproved new drug is made prior to an office procedure and takes the form of medication problem-solving consistent with pharmaceutical care models, there is an opportunity for patients to be included in an informed decision-making process. In the absence of informed decision-making, patient autonomy is breached and patients are denied the basic human right to self-determination and to protect themselves from unnecessary harm involving compulsory treatment with a drug that does not meet national standards.
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