Tone_Life
Well-known member
Hey all,
Just a heads-up: the FDA's looking for feedback on compounding regulations (deadline's comin' up quick, July 18th!). They seem to be leaning towards stricter rules, and we need to make our voices heard to protect access to compounded meds.
https://www.regulations.gov/searchResults?rpp=25&po=0&s=compounding+pharmacies&fp=true&ns=true
Here's what I sent in, focusing on my work with HIV patients. Feel free to adapt it with your own experiences (TRT, HRT, etc.).
"The FDA should include community representatives when creating guidances for compounding pharmacies. Stricter requirements on 503A and 503B facilities will cut patient options.
High pharma prices are causing huge problems. The focus should be on making affordable compounded medications MORE available, not less.
I appreciate the FDA's safety efforts, but overdoing it will hurt patients.
Many patients think the FDA is controlled by big pharma, which is probably unfair, but more restrictions on compounding will only reinforce that.
A recent report reminded the FDA that compounding pharmacies aren't drug manufacturers. They're state-licensed healthcare providers inspected by state boards. Adding big pharma-like regulations is an unnecessary burden for these small businesses.
Without affordable compounded meds, many of my non-profit's clients would have suffered from HIV wasting and other issues. We often need medications that insurance won't cover, so compounded products are vital for our quality of life.
Please carefully consider the impact of extra burdens on these small businesses, especially since existing sterility guidelines already address the problems caused by a few bad companies."
Here's a letter from Congress about it too:
https://c.ymcdn.com/sites/iacp.site-ym.com/resource/resmgr/DQSA/Stewart_Cuellar_Office_Use_L.pdf
Just a heads-up: the FDA's looking for feedback on compounding regulations (deadline's comin' up quick, July 18th!). They seem to be leaning towards stricter rules, and we need to make our voices heard to protect access to compounded meds.
https://www.regulations.gov/searchResults?rpp=25&po=0&s=compounding+pharmacies&fp=true&ns=true
Here's what I sent in, focusing on my work with HIV patients. Feel free to adapt it with your own experiences (TRT, HRT, etc.).
"The FDA should include community representatives when creating guidances for compounding pharmacies. Stricter requirements on 503A and 503B facilities will cut patient options.
High pharma prices are causing huge problems. The focus should be on making affordable compounded medications MORE available, not less.
I appreciate the FDA's safety efforts, but overdoing it will hurt patients.
Many patients think the FDA is controlled by big pharma, which is probably unfair, but more restrictions on compounding will only reinforce that.
A recent report reminded the FDA that compounding pharmacies aren't drug manufacturers. They're state-licensed healthcare providers inspected by state boards. Adding big pharma-like regulations is an unnecessary burden for these small businesses.
Without affordable compounded meds, many of my non-profit's clients would have suffered from HIV wasting and other issues. We often need medications that insurance won't cover, so compounded products are vital for our quality of life.
Please carefully consider the impact of extra burdens on these small businesses, especially since existing sterility guidelines already address the problems caused by a few bad companies."
Here's a letter from Congress about it too:
https://c.ymcdn.com/sites/iacp.site-ym.com/resource/resmgr/DQSA/Stewart_Cuellar_Office_Use_L.pdf
