HB 7077: Non-Resident Sterile Compounding Permits
This bill requires a non-resident pharmacy or an outsourcing facility that is not located in this state to obtain a non-resident sterile compounding permit prior to sending a compounded sterile product into this state. Currently-registered non-resident pharmacies must be permitted by February 28, 2015. Any compounded sterile product shipped, mailed, delivered, or dispensed into this state must meet or exceed this state’s standards for sterile compounding. The bill establishes application and inspection requirements for the nonresident sterile compounding permit as well as responsibilities for the Department of Health and the Board of Pharmacy to develop application forms, fees, and additional procedures to administer the permit. The Department and Board are provided with enhanced oversight responsibility for these entities including authority to inspect a non-resident pharmacy or a non-resident sterile compounding permittee; the cost of which is to be borne by the pharmacy or permittee. The Board is authorized to discipline a non-resident pharmacy for conduct which causes or could cause serious bodily or psychological injury to a human or serious bodily injury to an animal immediately, without waiting 180 days for the resident state to act. The Board is also authorized to discipline non-resident pharmacies and non-resident sterile compounding permittees for specified acts of noncompliance.
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This bill requires a non-resident pharmacy or an outsourcing facility that is not located in this state to obtain a non-resident sterile compounding permit prior to sending a compounded sterile product into this state. Currently-registered non-resident pharmacies must be permitted by February 28, 2015. Any compounded sterile product shipped, mailed, delivered, or dispensed into this state must meet or exceed this state’s standards for sterile compounding. The bill establishes application and inspection requirements for the nonresident sterile compounding permit as well as responsibilities for the Department of Health and the Board of Pharmacy to develop application forms, fees, and additional procedures to administer the permit. The Department and Board are provided with enhanced oversight responsibility for these entities including authority to inspect a non-resident pharmacy or a non-resident sterile compounding permittee; the cost of which is to be borne by the pharmacy or permittee. The Board is authorized to discipline a non-resident pharmacy for conduct which causes or could cause serious bodily or psychological injury to a human or serious bodily injury to an animal immediately, without waiting 180 days for the resident state to act. The Board is also authorized to discipline non-resident pharmacies and non-resident sterile compounding permittees for specified acts of noncompliance.
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