Are 503A compounding pharmacies about to end?

[HealthMan]

I just received this from a compounding pharmacy I have used in the past.

https://www.savemycompounds.com/

Are 503A compounding pharmacies coming to an end?

 

[TLR]

I always love it when the bureaucracy comes to the rescue for our own good.....

 

[xqfq]

I signed the letter.

Does anyone know if this would apply to Empower Pharmacy, which is a 503B pharmacy?

 

[xqfq]

Reading the website, there is this quote:

"There are several differences between the 503A and 503B operations.503B outsourcing facilities are entities that can produce a large volume of sterile compounded medications and are under the direct regulation of the FDA.Save My Compounds is most concerned with the traditional practice of pharmacy compounding and will focus on the regulatory framework for 503A entities, which are primarily regulated by state boards of pharmacy."

Places like Empower are 503B and are, according to this, directly regulated by the FDA. It seems the proposed changes involve only 503A pharmacies. The proposed changes here pertain to how these pharmacies must report to state boards of pharmacy (some kind of "MOA" to be signed), and so it would follow that 503B pharmacies would not be at risk here?

 

[HealthMan]

503B are ok but there are not many out there

 

[Nelson Vergel]

503 A will remain in operation. They will have to upgrade equipment to comply with FDA regs on injectables. Orals and creams will be OK.

Empower Pharmacy is a 503 b.

Interview with Compounding Product Expert Shaun Noorian from Empower Rx Pharmacy- Part 1 - ExcelMale

Interview with Compounding Product Expert Shaun Noorian- Part 2

 

[xqfq]

One of the articles made it seem like the major problem will be the pharmacies won’t be able to ship across state lines anymore. I suspect this would stop a lot of business.