FDA'S Crackdown on Compounded Drugs.

[ru4cats]

This came across my email inbox this morning and wondered if anyone knew how this would affect some of the compounded drugs people with MS have been relying on for years, i.e. 4-ap and LDN.

http://www.raps.org/Regulatory-Focus...ailable-Drugs/

Anybody want to hazard a guess?

[jreagan70]

The article is very clear that the guidance documents it's referring to affect only "Compounded Drug Products that are Essentially Copies of Approved Drug Products," meaning essential duplicates of commercially available or approved drugs.

4-AP by itself isn't an approved or commercially available drug, so these two FDA guidance documents don't apply to 4-AP and won't affect the availability of the compounded product.

Naltrexone in higher doses is commercially available and approved, but not in the low-dose form. Since the low-dose form is not commercially available and has to be compounded, these two guidance documents shouldn't affect LDN, either.

The FDA may take action against compounders and compounded drugs later for other reasons, but for now, MSers taking 4-AP and LDN shouldn't have any trouble continuing to get them from compounding pharmacies.
“Compounded Drug Products That Are Essentially Copies of Approved Drug Products” - See more at: http://www.raps.org/Regulatory-Focus....U39PTBNc.dpuf
“Compounded Drug Products That Are Essentially Copies of Approved Drug Products” - See more at: http://www.raps.org/Regulatory-Focus....U39PTBNc.dpuf

“Compounded Drug Products That Are Essentially Copies of Approved Drug Products” - See more at: http://www.raps.org/Regulatory-Focus....U39PTBNc.dpuf

[ru4cats]

Thanks for the reply, jreagen70. I've been on Ampyra for six years, but once I go on Medicare in February, I lose the subsidized cost of only $40 a month. I'd like to try 4-ap to see if I get the same results at the same cost. I thought Ampyra was just 4-ap turned into an extended time release formula. But from what you said, 4-ap is different enough from Ampyra to not fit in this category described in the release as an "essential copy."

[jreagan70]

Hi ru4cats:

You're right that Ampyra is basically 4-AP in a time-released version. But it's the chemicals and the formulation causing it to be time-released that make it a "commercially available and approved" drug. 4-AP by itself -- not in the time-released formulation -- doesn't fit that category. So unless and until the FDA restricts compounding in another way, you should be good to go with compounded 4-AP.

[ru4cats]

Whew! Thanks. Next stop my neurologist's appointment next month.