Idaho Board of Pharmacy Reminder that All Compounding in State Must be Patient Specific and Not Office Use

Compounding

As stated in the March 2014 Board Newsletter, pharmacies

must dispense compounded drug product pursuant to a patients pecific

prescription drug order. Compounded drug product that

is distributed in the absence of a patient-specific prescription drug

order is rendered as manufactured. In other words, both federal

and state law prohibit pharmacies from distributing compounded

drug products for “office use.” Federal law allows for a new

category of drug outlet to meet “office use” needs: the outsourcing

facility. You may access a list of Food and Drug Administration

 

registered

outsourcing facilities at the following link: www

 

.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/

PharmacyCompounding/ucm378645.htm. The Board has been

enforcing such law on a priority basis and will immediately begin

enforcement of such law for all sterile compounded drug product.

All sterile compounded drug product must be dispensed by a

pharmacy pursuant to a patient-specific prescription drug order

and not distributed by a pharmacy for “office use.” Prescribers and

hospitals are required to obtain “office use” sterile compounded

drug product from federally registered outsourcing facilities.

quoted from here