Virginia Bill to Implement Stricter Inspection Requirements for Nonresident Compounding Pharmacies Under Consideration

Stricter inspection requirements for nonresident compounding pharmacies and a clarification that distinguishes compounding from manufacturing are among the statutory changes included in House Bill 2312 currently being considered by the Virginia Legislature. If the bill passes, nonresident pharmacies will be required to submit to the Virginia Board of Pharmacy documentation of an inspection conducted within the past six months for new applicants and within the past two years for renewals. The inspection must be conducted by the regulatory agency of the jurisdiction in which the pharmacy is located and must comply with Virginia requirements, including compliance with US Pharmacopeia standards for compounding. The Board may also accept inspection reports from another entity that is satisfactory to the Board. The bill would also add to a list of prohibited practices “the compounding of inordinate amounts of any preparation” when “there is no observed historical pattern of prescriptions and dispensing to support an expectation of receiving a valid prescription for the preparation.” Under the bill, this practice would constitute manufacturing. A senate amendment to the bill requires that the pharmacist-in-charge or owner of a nonresident pharmacy notify the Board if it intends to dispense or otherwise deliver sterile compounded drug products. The bill would also authorize the summary suspension of a pharmacy permit without a hearing if the Board finds that there is a substantial danger to the public health or safety. In such cases, the Board would be required to simultaneously initiate proceedings for a hearing. As of February 19, 2013, the bill had been passed by the Virginia Senate and was placed on the calendar of the Virginia House of Delegates.