WASHINGTON — It’s been five years since Congress gave the Food and Drug Administration sweeping authority to regulate compounding, but lawmakers — many of whom wrote that law — still don’t think the FDA is properly regulating the growing industry. The problem is, lawmakers can’t seem to agree on the tack the agency should take.
And they’re not the only ones pulling the FDA in different directions.
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Proposterous! And misleading at best. How long will you constantly be pivoting for your self interests all the while attempting to maintain a semblance of neutrality? Compounders are the hidden gems and an essential in the world of alternative/designer preparations for those out of the box clinicians who want to travel the extra mile in service to the needs of the patient instead of simply towing the party line with the commercial interests. The vast majority of compounders and their labs are scrutinized by the FDA and state boards at rates far higher than existing big pharma labs to ensure compliance levels above and beyond reproach. This ‘ramping up business’ is self-delusional, politics, cronyism and indulgent reproachful feeding at the troughs of pig pharma.
Most FDA approved drugs could kill me due to corn and milk allergens in them, so I need compounds without the allergens. Two of the drugs I take do not have appropriate doses or forms and must be compounded. There are no FDA-approved drugs for 2 of the conditions I have, but some of the 503a and 503b bulk compinfing substances can help me, though the FDA is trying to ban them…and then there will be notning to take.
I need compounds. Even my insurance company agrees I do. There are laws that cover safety today. I use compounders my doctor and I trust.
The FDA has no business getting between me and my doctor and keeping me from getting substances that treat my serious illness. They have already banned multiple substances that are useful in my care without eben considering the conditions my doctor is prescribing them for.
I am scared that there will not be compounds available to treat me and I could die as a result.
I have almost 40 years experience in pharma manufacturing and qc. There are few controls governing batch uniformity and dose uniformity, particularly for capsule dosage forms. My recent experience with a tricomponent antibiotic-antimicrobial-antifungal customer compounding was disastrous.
What happened?