Disciplinary record on judicial review. Creates § 151.075. Requires the court to seal the administrative record, except for the final decision. board’s Records of prescriptions. Amends § 151.211. Subd. 1. Retention of prescription drug orders. Requires prescription drug orders to be retained at the location from which the drug was dispensed for at least two years. Subd. 2. Refill requirements. Allows drug orders to be refilled with the consent of the prescriber and in accordance with laws and rules. Requires the date of refill to be noted and initialed by the pharmacist, intern or practitioner who refills the prescription. Creates § 151.251. Compounding. Provides that Subd. 1. Exemption from manufacturing licensure requirements. a pharmacist in a pharmacy or a practitioner who are engaged in extemporaneous or anticipatory compounding or compounding not done pursuant to a prescription order are exempt from manufacturing license requirements. Subd. 2. Compounded drug. Allows a pharmacist or practitioner to compound a drug product under specified conditions: the drug product must be compounded from bulk drug substances that meet listed requirements; ingredients, other than bulk drug substance, must comply with specified standards; the drug products do not appear on the federal DHHS list of drug products withdrawn or removed from the market; the drug products are not essentially copies of commercially available drug products; and the drug product has not been identified as one that presents demonstrable difficulties for compounding such that there is an adverse effect on the safety or effectiveness of the drug product. Provides that this section does not apply to compounded PET Subd. 3. Exception. drugs or radiopharmaceuticals. Outsourcing facility. Amends § 151.252, by adding subd. 1a. Requires any person seeking to act as an outsourcing facility to apply and obtain a license from the board and pay the applicable manufacturer licensing fee. Requires the facility to provide the board with proof that the outsourcing facility is registered with the FDA and in compliance with all laws and rules. Requires facilities physically located in other states to be licensed or registered in that state. Requires a separate license for each outsourcing facility. Requires the facility to pass an inspection conducted by a representative of the board.
Disciplinary record on judicial review. Creates § 151.075. Requires the court to seal the administrative record, except for the board’s final decision. Records of prescriptions. Amends § 151.211. Subd. 1. Retention of prescription drug orders. Requires prescription drug orders to be retained at the location from which the drug was dispensed for at least two years. Subd. 2. Refill requirements. Allows drug orders to be refilled with the consent of the prescriber and in accordance with laws and rules. Requires the date of refill to be noted and initialed by the pharmacist, intern or practitioner who refills the prescription. Compounding. Creates § 151.251. Subd. 1. Exemption from manufacturing licensure requirements. Provides that a pharmacist in a pharmacy or a practitioner who are engaged in extemporaneous or anticipatory compounding or compounding not done pursuant to a prescription order are exempt from manufacturing license requirements. Subd. 2. Compounded drug. Allows a pharmacist or practitioner to compound a drug product under specified conditions: the drug product must be compounded from bulk drug substances that meet listed requirements; ingredients, other than bulk drug substance, must comply with specified standards; the drug products do not appear on the federal DHHS list of drug products withdrawn or removed from the market; the drug products are not essentially copies of commercially available drug products; and the drug product has not been identified as one that presents demonstrable difficulties for compounding such that there is an adverse effect on the safety or effectiveness of the drug product. Subd. 3. Exception. Provides that this section does not apply to compounded PET drugs or radiopharmaceuticals. Outsourcing facility. Amends § 151.252, by adding subd. 1a. Requires any person seeking to act as an outsourcing facility to apply and obtain a license from the board and pay the applicable manufacturer licensing fee. Requires the facility to provide the board with proof that the outsourcing facility is registered with the FDA and in compliance with all laws and rules. Requires facilities physically located in other states to be licensed or registered in that state. Requires a separate license for each outsourcing facility. Requires the facility to pass an inspection conducted by a representative of the board.
02402a14Liebling.hhs.docx