October 2007               return to newsletter contents page

Updates from State Monitor as of 9/25/07

Content changes

• US House Bill 3580 has been passed by the House and the Senate and awaits presidential signature. This Omnibus bill replaces many previous bills that would affect pedigree, and anti-counterfeit measures. The Secretary is charged with developing new standards for serialization in 30 months. Outdated/conflicting legislation has been removed.

• Colorado has passed final licensing/pedigree regulations (effective Sept. 30, 2007), implementing the previous Senate Bill 217.

• Florida admin code § 64F-12.025 has been changed. The word “Certificate” is used to replace “Digital Signature,” along with other editorial amendments.

• Florida has provided notice of intent to develop pedigree rules for drugs packaged with devices. Details of the notice have been included here. Also changes to the definitions used in regulations have been proposed.

• Illinois Senate Bill 509 is still included with pending legislation. The Bill has been passed by the legislature and forwarded to the Governor for signature. Without signature or veto, the law becomes effective after 60 days.

•  Nebraska has promulgated and approved final regulations pursuant to pedigree provisions of the Wholesale Drug Distributor Licensing Act.

• The North Dakota Board of Pharmacy has advised the new pedigree and licensure provisions will not be enforced until January 1, 2008 for new licensees; enforced June 1, 2008 for renewed licensees.

• Oklahoma has adopted rules and regulations for implementing pedigree law on an emergency basis.

• Tennessee Senate Bill 1197 [House Bill 1190] has been amended, fleshing out authentication and other pedigree provisions.

• Virginia has proposed regulatory changes which would require non-emergency distribution of drugs by secondary wholesalers to comply with pedigree and authentication requirements.

Editorial changes

• Definition of Manufacturer added to introductory section.

• California’s entry has been expanded for context.

• The contents of Colorado Senate Bill 217 [previously adopted] have been placed in a codified format, replacing the format of the Senate Bill.

• Delaware edited for brevity.

• Georgia’s 'Prescription Medication Integrity Act’ [previously adopted] has been placed in a codified format, replacing the format of the Senate Bill.

• The contents of Idaho Senate Bill 1184 “Idaho Wholesale Drug Distribution Act” [previously adopted] have been placed in a codified format, replacing the format of the Senate Bill.

• The contents of Maryland Senate Bill 759 [previously adopted] have been placed in a codified format, replacing the format of the Bill.

• New Jersey administrative code change to reflect codified format; previous edition reported text from administrative register.

• The contents of North Dakota House Bill 1455 [previously adopted] have been placed in a codified format, replacing the format of the House Bill.

• Pennsylvania House Bill 311 has been reformatted for easier reading.

• The contents of South Dakota House Bill 1155 [previously adopted] have been placed in a codified format, replacing the format of the House Bill.

• The contents of Texas Senate Bill 943 [previously adopted] have been placed in a codified format, replacing the format of the House Bill.