Guidelines – Anesthetics

 

Guidelines for Permanent Makeup Anesthetics

SPCP Guidelines
September 2007

Anesthetics sold by supplier members or vendors cannot be prepared by compounding pharmacies, but rather must be sold to the supplier member or vendor by FDA Manufacturers.

Explanation and Implementation:

Whenever a pharmacy compounds a formula, even at over-the-counter levels, it is considered a prescription drug and cannot be dispensed without a prescription. Also, compounding pharmacies do not fall under FDA scrutiny. This lack of scrutiny has been linked to two deaths and resulted in an FDA Public Advisory.1

As a result of the FDA’s findings, Supplier Members selling topical anesthetics must use FDA Manufacturers and must supply a copy of their lab’s Manufacturing License to the SPCP. This license insures accurate expiration dates and assay testing for safe levels of active ingredients.

The Board of the SPCP understands that this information is proprietary and confidential, but in order to maintain our high professionals standards, it is required for future membership and sales at SPCP sponsored events. If disclosure of confidential information is of concern, a notarized statement from a lawyer stating that the supplier has shown them all information and that they met the standard will be accepted.

 

See Also: http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm079047.htm