What does this mean for Empower?

[Bryan_K77]

https://www.fda.gov/media/130590/download

 

[Jason Sypolt]

The bulks list changed. There are lists of products and substances that they are allowed to produce and other lists that they are not allowed to produce. They have more regulation because they are a 503B which puts them roughly on par with a big pharma manufacturer in terms of quality/consistency They made the products for patients as long as they could until they were forced to stop making some of them after repeated warnings such as the GHRP's, Gaba, Calm.

 

[Dcalicotte03]

Im not sure on the details but I just talked to them today on the phone. They said some pharmacies won’t be able to make hcg and fsh but they aren’t one of them and they can continue to make them

 

[Jason Sypolt]

Im not sure on the details but I just talked to them today on the phone. They said some pharmacies won’t be able to make hcg and fsh but they aren’t one of them and they can continue to make them

The HCG and FSH problems are really separate now and apply to nearly every compounding pharmacy. There was a law passed in 2009, the BPCIA which is only now taking effect (on March 23rd). The FDA classified HCG and FSH as biologics (because they are). Biologics are derived from living tissue or DNA and HCG was derived from urine. The FDA did not consider the tiny compounding industry 10 years ago and so there was no commenting period to oppose the change. The law is actually intended to lower prices of biologics like HCG, FSH, and HGH but the net effect is that now it is going to harm most compounders. No one is allowed to produce biologics without a BLA license. The license application costs hundreds of thousands of dollars and it can take 18 months to obtain. Most pharmacies - the small 503A's, can't even get it because you have to have a cGMP facility to meet new quality and safety standards.

Here is more info: The FDA and hCG