Loading chat...
ND SB2086
Bill
Status
4/6/2015
Primary Sponsor
Industry, Business and Labor Committee
Click for details
AI Summary
-
Creates regulatory framework for outsourcing facilities engaged in anticipatory compounding of sterile drugs, requiring FDA registration under 21 U.S.C. 353(b) and state licensure with a designated responsible pharmacist.
-
Establishes separate licensing requirements and standards for third-party logistics providers that contract with manufacturers or wholesalers to provide warehousing and distribution services without taking title to drugs or medical equipment.
-
Amends definitions in North Dakota Century Code to clarify the roles of authorized distributors of record, third-party logistics providers, outsourcing facilities, and other wholesale distribution entities in the drug supply chain.
-
Sets licensing fees at $200 for outsourcing facilities and $400 for third-party logistics providers under the state board of pharmacy's regulatory authority.
-
Requires outsourcing facilities to provide inspection reports and FDA objectionable condition reports to the board within 48 hours of request and comply with all federal labeling and recordkeeping requirements.
Legislative Description
The wholesale drug distribution and third-party logistic providers.
Last Action
Signed by Governor 04/06
4/6/2015