Congress did take one important step by amending the drug misbranding provisions under 21 USC 353 to include compounded drugs. Borrowing from the rules governing approved drugs, a compounded drug is misbranded under the FDCA:
if the advertising or promotion of a compounded drug is false or misleading in any particular.
The new Compounding Quality Act will pave the way for increased use of the FDA's 2002 Compounding Policy Guide(CPG) for oversight of the promotion of pharmacy compounding products for both sterile and other compounded products. CPG Sec. 140.100 addresses the circumstances under which the FDA will seize books and other materials that constitute misleading labeling and states:
Printed material that promotes the use of a product is labeling within the meaning of the Act. Notwithstanding certain free speech protections, labeling including books can be regulated if it is false or misleading.
1 comment:
So less ads by compounding pharmacies for HCG diet treatments? Less ads stating "oral/sublingual HCG can be absorbed" even though HCG is 6x bigger than insulin and cannot be absorbed? Less ads for HGH anti-aging treatments?
Perhaps, perhaps not. Ads directed to prescribers and dispensing practitioners might NOT be covered as they aren't directed to the GENERAL PUBLiC. That might be a loophole unethical compounding pharmacies use to tout their wares.
Kenneth Woliner, MD
www.holisticfamilymed.com
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