Thursday, February 7, 2013

New Mexico Board of Pharmacy Notice to Non-Resident Pharmacies Licensed within State

New Mexico Regulation and Licensing Department
Board of Pharmacy
5200 Oakland Avenue, NE ▪ Sui te A ▪ Albuquerque, New Mexico 87113
(505) 222-9830 ▪ F a x ( 5 0 5 ) 222-9845 ▪ (800) 565-9102
www. r
January 28, 2013
To: Non-resident pharmacies licensed with the NM Board of Pharmacy
Re: Required licensure/registration and standard of operation
Recent outbreaks of infections linked to contaminated injectable products made
and distributed by non-FDA registered entities have increased awareness of this
issue and the importance of its prevention. In the interest of public health and
safety, this letter is to provide information regarding FDA and NM Board of
Pharmacy registration requirements as determined by pharmaceutical
compounding activities, and required standard of operation.
Simply stated, a pharmacy may compound a patient-specific sterile product
pursuant to a prescription or order for an individual patient. Unless otherwise
exempt {21CFR207.10}, preparation of non-patient specific compounded
sterile product is considered manufacturing, and requires registration with the
FDA and the NM Board of Pharmacy as a wholesaler/distributor. The required
standard of operation for preparation of compounded sterile products is

compliance with USP <797>.
Larry Loring,
Executive Director/Chief Inspector
New Mexico Board of Pharmacy

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