Thursday, March 6, 2014

New Mexico Board of Pharmacy Removes Section allowing for compounding of nonsterile pharmaceuticals for office use

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.
quoted here

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