In 2006 the FDA warned consumers about compounded products offered as creams and ointments--

Creams

FDA is also concerned about some compounded products offered as creams and ointments.

Traditional pharmacy compounding is a practice in which pharmacists combine, mix, or alter ingredients to create unique medications to meet specific medical needs of individual patients in accordance with prescriptions issued by patients’ doctors.

Compounded drugs are not reviewed by FDA for safety and effectiveness, and are not FDA-approved. They can expose patients to unnecessary risks when they are used without proper medical supervision.

FDA normally permits traditional pharmacy compounding. By contrast, some pharmacies behave like drug manufacturers, not traditional compounding pharmacies, because they produce standardized versions of products for general distribution.

In December 2006, FDA warned five firms to stop compounding and distributing topical anesthetic creams that were being marketed for general distribution rather than responding to the unique medical needs of individual patients.

Compounded topical anesthetic creams are often used to lessen pain in procedures such as laser hair removal, tattoos, and skin treatments. They are sometimes dispensed by clinics and spas that provide these procedures, or by pharmacies and doctors’ offices.

The compounded topical anesthetics that FDA warned about contain high doses of local anesthetics, including lidocaine, tetracaine, benzocaine, and prilocaine. FDA has warned that when different anesthetics are combined into one product, each anesthetic’s potential for harm is increased.

This potential harm may also increase if the product is left on the body for long periods of time or applied to broad areas of the body, particularly if an area is then covered by a bandage, plastic, or other dressing.

For more information

FDA Warns Five Firms to Stop Compounding Topical Anesthetic Creams

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


quoted from here