Nonsterile Compounding
As mentioned in a previous Newsletter article, during the
April 18-19, 2013 Board meeting, the Board removed the section
allowing for compounding of nonsterile pharmaceuticals
for practitioner’s office use (16.19.30.9 NMAC).
During the October 17-18, 2013 Board meeting, this regulation
was clarified. Veterinarians within New Mexico were
asking for a waiver to this rule. The Board stated within the
regulation:
(4) Compounding veterinarian products.
(a) Products for animals may be compounded
based on an order or prescription from a duly
authorized veterinarian.
(b) These products are to be handled and filled the
same as the human prescriptions.
The intent of this regulation revision is to allow pharmacists
to compound veterinary products for the veterinarian to use
in his office. Therefore, a pharmacist may compound a nonsterile
product for veterinarian use.
On November 27, 2013, H.R. 3204 – Drug Quality and
Security Act, was passed by Congress and signed into law by
the president. The revision allows pharmacies to compound
medications for bulk sale to licensees. The pharmacy, known
as an outsourcing facility, must be registered with FDA. These
outsourcing facilities are expected to comply with FDA rules
with certain exceptions.
A list of facilities to be registered as Human Drug Compounding
Outsourcing Facilities with FDA can be found
on the FDA web page at www.fda.gov/drugs/guidance
complianceregulatoryinformation/pharmacycompounding/
ucm378645.htm. No pharmacy registered in New Mexico
has registered. However, this would be allowed. Pharmacies
on this list may sell to New Mexico licensees if they license
with the Board as a wholesaler.
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