Re: FDA WARNS AGAINST COMPOUNDED ANESTHETIC CREAMS (aka lidocaine, etc.)

[Guest guest]

I have never heard of anybody from these lists

compounding more than one anaesthetic in their

creams--just different secondary ingredients like emu

oil, etc. Do you suppose this is the truth or some

kind of turf war and nastiness? I guess it doesn't

matter. Weirdness afoot again.

Arline

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[Guest guest]

I think your message subject is a

little misleading, Dee. The FDA did

NOT warn anyone about the compounded creams themselves; they were warning the

compounders themselves, NOT the general public, nor the members of this

list.

The basis of the warning appears

to be that they are making a “general” product, that competes with

commercially available products, when in fact they are only licensed to make

products that are tailored to meet the specific medical needs of individual

patients.

I suspect that a closer examination

of this list and its messages will reveal that there are some major deficiencies in the “standard”

commercial products, which the compounders are trying to overcome. The FDA probably doesn’t even

realize that lidocaine is being used intravaginally by many patients with

vulvodynia, and they didn’t expect to find some many similar orders from

people like those on this list.

I hope those with direct

connections with compounders will get more information and help provide

documentation to them to ensure that our access to the compounded product is

not interrupted! They

need to know that we can muster hundreds of letter-writers who will tell the

FDA that they NEED products that are made with less irritating bases. People who need these compounded

products should gather notes about their personal experience with the limited formularies

of the commercially available products.

, PhD

From: VulvarDisorders

[mailto:VulvarDisorders ] On Behalf Of DeeTroll

Sent: Monday, December 11, 2006 5:40 PM

To: Dee Troll

Subject: FDA WARNS AGAINST COMPOUNDED ANESTHETIC CREAMS (aka

lidocaine, etc.)

Oh oh...

FDA News

FOR IMMEDIATE RELEASE

P06-192

December 5, 2006

FDA Warns Five

Firms To Stop Compounding Topical Anesthetic Creams

The Food and Drug Administration (FDA) is warning five firms, Triangle

Compounding Pharmacy, University Pharmacy, Custom Scripts Pharmacy, Hal’s

Compounding Pharmacy, and New England Compounding Center, to stop compounding

and distributing standardized versions of topical anesthetic creams, which are

marketed for general distribution rather than responding to the unique medical

needs of individual patients. Firms that do not resolve violations in FDA

warning letters risk enforcement such as injunctions against continuing

violations and seizure of illegal products. To read More.....

or go to...

http://www.fda.gov/bbs/topics/NEWS/2006/NEW01516.html

[Guest guest]

I think your message subject is a

little misleading, Dee. The FDA did

NOT warn anyone about the compounded creams themselves; they were warning the

compounders themselves, NOT the general public, nor the members of this

list.

The basis of the warning appears

to be that they are making a “general” product, that competes with

commercially available products, when in fact they are only licensed to make

products that are tailored to meet the specific medical needs of individual

patients.

I suspect that a closer examination

of this list and its messages will reveal that there are some major deficiencies in the “standard”

commercial products, which the compounders are trying to overcome. The FDA probably doesn’t even

realize that lidocaine is being used intravaginally by many patients with

vulvodynia, and they didn’t expect to find some many similar orders from

people like those on this list.

I hope those with direct

connections with compounders will get more information and help provide

documentation to them to ensure that our access to the compounded product is

not interrupted! They

need to know that we can muster hundreds of letter-writers who will tell the

FDA that they NEED products that are made with less irritating bases. People who need these compounded

products should gather notes about their personal experience with the limited formularies

of the commercially available products.

, PhD

From: VulvarDisorders

[mailto:VulvarDisorders ] On Behalf Of DeeTroll

Sent: Monday, December 11, 2006 5:40 PM

To: Dee Troll

Subject: FDA WARNS AGAINST COMPOUNDED ANESTHETIC CREAMS (aka

lidocaine, etc.)

Oh oh...

FDA News

FOR IMMEDIATE RELEASE

P06-192

December 5, 2006

FDA Warns Five

Firms To Stop Compounding Topical Anesthetic Creams

The Food and Drug Administration (FDA) is warning five firms, Triangle

Compounding Pharmacy, University Pharmacy, Custom Scripts Pharmacy, Hal’s

Compounding Pharmacy, and New England Compounding Center, to stop compounding

and distributing standardized versions of topical anesthetic creams, which are

marketed for general distribution rather than responding to the unique medical

needs of individual patients. Firms that do not resolve violations in FDA

warning letters risk enforcement such as injunctions against continuing

violations and seizure of illegal products. To read More.....

or go to...

http://www.fda.gov/bbs/topics/NEWS/2006/NEW01516.html

[Guest guest]

I think your message subject is a

little misleading, Dee. The FDA did

NOT warn anyone about the compounded creams themselves; they were warning the

compounders themselves, NOT the general public, nor the members of this

list.

The basis of the warning appears

to be that they are making a “general” product, that competes with

commercially available products, when in fact they are only licensed to make

products that are tailored to meet the specific medical needs of individual

patients.

I suspect that a closer examination

of this list and its messages will reveal that there are some major deficiencies in the “standard”

commercial products, which the compounders are trying to overcome. The FDA probably doesn’t even

realize that lidocaine is being used intravaginally by many patients with

vulvodynia, and they didn’t expect to find some many similar orders from

people like those on this list.

I hope those with direct

connections with compounders will get more information and help provide

documentation to them to ensure that our access to the compounded product is

not interrupted! They

need to know that we can muster hundreds of letter-writers who will tell the

FDA that they NEED products that are made with less irritating bases. People who need these compounded

products should gather notes about their personal experience with the limited formularies

of the commercially available products.

, PhD

From: VulvarDisorders

[mailto:VulvarDisorders ] On Behalf Of DeeTroll

Sent: Monday, December 11, 2006 5:40 PM

To: Dee Troll

Subject: FDA WARNS AGAINST COMPOUNDED ANESTHETIC CREAMS (aka

lidocaine, etc.)

Oh oh...

FDA News

FOR IMMEDIATE RELEASE

P06-192

December 5, 2006

FDA Warns Five

Firms To Stop Compounding Topical Anesthetic Creams

The Food and Drug Administration (FDA) is warning five firms, Triangle

Compounding Pharmacy, University Pharmacy, Custom Scripts Pharmacy, Hal’s

Compounding Pharmacy, and New England Compounding Center, to stop compounding

and distributing standardized versions of topical anesthetic creams, which are

marketed for general distribution rather than responding to the unique medical

needs of individual patients. Firms that do not resolve violations in FDA

warning letters risk enforcement such as injunctions against continuing

violations and seizure of illegal products. To read More.....

or go to...

http://www.fda.gov/bbs/topics/NEWS/2006/NEW01516.html