In February 2013, Washington Post published that IACP’s Executive Vice President David G. Miller stated, “We want to enable and clarify for the FDA that those businesses that are involved in the manufacturing of compounded drugs, regardless of size, be regulated like drug manufacturers.” This was an alleged change of view by IACP regarding industry regulation. However, immediately clarified that the Washington Post story “did not accurately reflect our position.” IACP provided the following statement in response:
I wanted to make sure you were aware that the Washington Post article which appeared on Friday alleging that IACP is now supporting FDA oversight of compounding pharmacy is neither accurate nor reflective of the complete story. In fact, IACP and our PR firm gave the reporter very specific written statements were given a spin by the journalist.
The following is the exact language we gave to the reporter:
1. IACP is supportive of a discussion about the creation of a category of non-traditional manufacturing. A formal position has not yet been taken by the IACP or, to our knowledge, by any other pharmacy organization. This is a concept that we believe needs to be reviewed and discussed in the public arena.
2. For this group of non-traditional manufacturers, if they are manufacturers, we would expect that the FDA would regulate them. The FDA would have to determine if the same criteria would be applied to this category as is applied to traditional manufacturers. Any compounding pharmacy – not a manufacturer, traditional or non-traditional – should continue to be regulated and overseen by state boards of pharmacy.
In short, IACPsupports a policy conversation about regulating manufacturing. We have not endorsed or supported a specific program, design, concept or anything else. Strictly a discussion. That is consistent with IACP’s statements to Congress and state regulatory authorities.
I’d sure appreciate your help in making sure that compounding pharmacists have the whole story.
David G. Miller, R.Ph.
Response taken from PBMAuditLawyers.com. Click here to view original source.