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.
1
http://www.fda.gov/cder/drug/advisory/topical_anesthetics.htm
SPCP Anesthetic Guidelines 09/07
