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At the last conference I went to, the "manufacturing" (i.e. non-traditional compounding pharmacies that do advertise for "national business" for prescriptions to be ordered in distant states from where the pharmacy is located, and to mail compounded medications to physician offices for administration and often further dispensing), were all distributing "fact sheets" saying "your compounding medications are at risk! Oppose this law!". These fact sheets were produced by the IACP, the same trade organization that helped strike down Section 353a of the Federal Food, Drug and Cosmetic Act, causing this "wild west atmosphere" of "non-traditional
compounders such as NECC, Franck's, and Apothecure, etc, engaging in manufacturing and wholesale distributing accross state lines.
In addition, they have convinced some physicians, such as Drs. Hotze and Hoktorf to send e-mail letters to their mailing lists to also gatemher opposition to the law.
In my humble opinion, these doctors, and "patients", who haven't even read the proposed legislation, are being
duped by "Big (Compounding) Pharma". This law will NOT prevent patients from getting compounded meds. If a compounding pharmacy wants to be exempt from the requirements of this law, all they have to do is:
- compound drugs in a "patient-specific manner", the way that was done for the longest time (before they realized they could make mega-bucks from manufacturing drugs in a grand scale without complying with all the safety requirements of a large manufacturer);
- not ship compounded drugs across state lines (also known as inter-state commerce). If they returned to being a "mom and pop" pharmacy serving the local community, the FDA would have no power over them.
Frankly, I believe "you reap what you sow.". IACP didn't self-police their rogue member pharmacies who donated large amounts of PAC money to co-opt the organization
into one that just provided political cover for their illegal (and dangerous/lethal) activities that have tarnished the entire "compoundednding pharmacy business".
Now the chickens have come home to roost. As long as compounding pharmacies "manufacture in bulk (in anticipation of future orders), and then ship these unapproved new drugs accross state lines, they should be regulated by a federal agency such as a (properly funded) FDA. If they don't like it, they could always "downsize" and serve their local community the way pharmacies did in the Jimmy Stewart "A Wonderful
Life" era. They should stop complaining. They should stop deceiving their physicians and patients by spreading misinformation about this law. They should instead stand up and say, "We don't like rogue compounding pharmacies that endanger patient safety."
They won't, of course. The ones who make the most $$$ by skirting the rules are rmtge ones funding the IACP PAC to oppose this law. The "mom and pop pharmacies" that support the law don't have the money to do a mass marketing campaign to support the law, and don't have the political clout in the IACP to get the IACP to stop their misinformation campaign.
Kenneth Woliner, MD
www.holisticfamilymed.com
i wish everyone would read this comment!!!
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