No. HB 877
Filed under Healthcare.
Active Pharmaceutical Ingredients; Authorizes sale, transfer, & distribution of certain compounded drugs; provides requirements for sale, transfer, & distribution of such medications; requires person engaging in sale, transfer, or distribution of compounded drugs to maintain certain records for specified timeframe; requires such person to furnish certain records to board upon request within specified timeframe; prohibits advertising or promotion of compounded drugs except; provides penalties; requires certain persons or entities to maintain certain records for specified timeframe & furnish such records to Board of Pharmacy within specified timeframe; authorizes Attorney General, in collaboration with Board of Pharmacy, to adopt rules.
Plain English Summary
AI-GENERATEDAnyone selling, transferring, or distributing a drug compounded from a bulk ingredient must confirm that ingredient meets strict sourcing rules — an existing USP monograph, FDA-approved-drug status, or the FDA's approved bulk-substance list.
Compounders must also verify a certificate of analysis, test the ingredient for purity before use, and confirm it was made in an FDA-registered facility inspected within the past two years.
Selling a noncompliant compounded drug triggers a $1,000 fine per dose sold, transferred, or distributed, and can cost a pharmacy or facility its license entirely.
Sellers must keep sourcing and testing records for at least two years and hand them to the Board of Pharmacy within one business day of a request; the board may also inspect compounders and their ingredient suppliers directly.
AIA drug compounded from a bulk substance may be sold, transferred, or distributed only if that substance meets a checklist of sourcing, quality-testing, and FDA-traceability requirements written into the new section.
AISelling a compounded drug that fails the sourcing checklist exposes the seller to a $1,000 fine for every dose involved, plus revocation of the pharmacy or facility license.
AISellers must keep acquisition and testing records on the bulk substance for at least two years after the drug's last lot expires, and produce them within one business day of a board request.
AIThe board or an approved third party may inspect not just compounders but their bulk-ingredient suppliers, and refusing to allow an inspection is itself a violation of the section.