Compounding Pharmacy’s License Suspended

The Vermont Board of Pharmacy suspended a compounding pharmacy’s license after finding that the “beyond-use” dates on the drugs exceeded regulations.

Penro Specialty Compounding in Colchester, VT, and its pharmacist manager, Neal Pease, RPh, compounded drugs with beyond-use dates ranging from 90 to 180 days for drugs that should be stored no more than 45 days, the Board said in the order suspending the pharmacy’s license.

Pease’s license was also suspended.

“Mr. Pease produced a list of 550 compounds which has been compounded and dispensed and which did not conform to the standard ‘beyond-use’ date for high-risk sterile compounds,” the Board said in the order. The compounded medications included injectables and ophthalmic compounds.

Related article: How the NECC Case Changed Compounding Pharmacy

Pease based the beyond use dates on the stability of the ingredients, he told Board representatives during an October 20, 2017, visit to the pharmacy. During an October 18, 2017, inspection by the Board, Pease also made it clear that he did not do sterility assurance testing on his compounded medications, the order said.

“Because the high-risk sterile drugs were dispensed with improperly long beyond-use dates, there was a risk that patients would suffer infections or even death,” the Board said.

The Board recommended that all drugs that had been dispensed with the inappropriate dates should be recalled, and Pease said he complied with the request.

Pease acknowledged he was “confused” by the beyond-use sterility regulations, and urged the Board not to suspend his license.

“Given the clear rules concerning sterile compounding for high-risk compounds, the Board finds the confusion by Mr. Pease to be incredible, or a gross breach of professional duty,” the Board said.

Penro, which compounds both human and veterinary compounds, employs one pharmacist, several pharmacy techs, and pharmacy interns.