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Board flags gaps in nonresident pharmacy applications; two sterile-focused applicants denied pending updates
Summary
Board members reported improved electronic applications but said Super Saver and FarmCore sterile pharmacy still lack required documentation; the department is also investigating nonresident pharmacies that shipped products into Connecticut without licenses.
At the Aug. 27 meeting the Connecticut Board of Pharmacy reviewed its nonresident pharmacy application caseload and reported an increase in cases involving pharmacies that shipped products into Connecticut without holding a Connecticut nonresident license.
Commissioner Waddington reported that the board's updated electronic application "seems to be working much better," but said several applicants remain incomplete. "We had 1 infusion center that applied and they documented that they received a warning from the FDA and they did not provide that letter to us," Waddington said. The board identified two applicants — Super Saver Pharmacy and FarmCore Sterile Pharmacy — as requiring additional documentation; FarmCore had "numerous sterility violations" on record and was recommended for denial until corrected submissions are provided.
Attorney Ando earlier described one enforcement matter in which a nonresident pharmacy shipped injectable doses into Connecticut without a Connecticut license; that case resulted in a $4,000 voluntary payment and a 30-day restriction on reapplication. Commissioner Waddington told the board she is tracking multiple nonresident matters and that three cases currently are being investigated by drug control for sending compounded products into Connecticut without a license.
The board discussed documentation required for sterile and nonsterile compounding: if an applicant performs sterile compounding, the board expects evidence consistent with USP 797; nonsterile compounding should meet USP 795 standards; hazardous compounding must comply with USP 800. The board also noted the need for current pharmacy licenses in the applicant's home jurisdiction.
Commissioners urged applicants to provide complete records, including inspection reports and any corrective actions, and warned that outstanding sterility violations and expired licenses will delay or prevent approval.
The board accepted motions to approve applications that had met requirements and to deny or continue review of those that had not, instructing staff to notify applicants of missing items and to withhold licensure until documentation is complete.
