HB 5262 Summary

• Modifies prescription brand-name drug requirements by allowing practitioners to specify "brand medically necessary" or "no substitution" through written, telephonic, or electronic means with specific documentation procedures for each method.

• Establishes new regulatory framework for sterile compounding pharmacies requiring addendum applications, compliance with United States Pharmacopeia Chapter 797 standards, and mandatory reporting of violations, environmental sampling issues, and product recalls to the Department of Consumer Protection.

• Requires nonresident pharmacies to disclose sterile pharmaceutical compounding activities, submit inspection reports based on USP Chapter 797 standards, notify the department of disciplinary actions within ten business days, and provide patient names and addresses during recalls within 24 hours.

• Creates prohibition on knowingly purchasing, selling, or delivering counterfeit drugs or devices, with enforcement authority granted to the Commissioner of Consumer Protection including civil penalties up to $1,000 per violation and criminal penalties up to $10,000 or one year imprisonment.

• Expands definition of "manufacturer" to include sterile compounding pharmacies dispensing without patient-specific prescriptions and requires such pharmacies to obtain manufacturer registration certificates from the Department of Consumer Protection.