Prescription drugs; manufacture and distribution in the Commonwealth. (HB528)

Introduced By

Del. Keith Hodges (R-Urbanna)

Progress

Introduced
Passed Committee
Passed House
Passed Senate
Signed by Governor
Became Law

Description

Manufacture and distribution of prescription drugs in the Commonwealth. Eliminates the requirement that the Board of Pharmacy establish and implement a pedigree system for recording each distribution of a controlled substance from sale by a pharmaceutical manufacturer to a dispenser or person who will administer the controlled substance; defines "co-licensed partner" as a person who, with at least one other person, has the right to engage in the manufacturing or marketing of a prescription drug, consistent with state and federal law, and specifies that a co-licensed partner may be a manufacturer of a controlled substance; and defines "third-party logistics provider" as a person who provides or coordinates warehousing of or other logistics services for a drug or device in interstate commerce on behalf of a manufacturer, wholesale distributor, or dispenser of the drug or device but does not take ownership of the product or have responsibility for directing the sale or disposition of the product. The bill specifies that bulk drug substances used for compounding drugs distributed by a supplier other than a licensed wholesale distributor or registered nonresident wholesale distributor must be provided by a supplier who is approved by the Board of Pharmacy as well as the federal Food and Drug Administration and requires every pharmacy, nonresident pharmacy, wholesale distributor, and nonresident wholesale distributor to comply with federal requirements for an electronic, interoperable system to identify, trace, and verify prescription drugs as they are distributed. The bill authorizes the Board of Pharmacy to deny, revoke, suspend, or take other disciplinary actions against holders of a third-party logistics provider permit, manufacturer permit, or nonresident manufacturer permit; applies the inspection and audit requirements that apply to wholesale distributors to nonresident wholesale drug distributors, third-party logistics providers, manufacturers, and nonresident manufacturers; creates a permitting process for third-party logistics providers; allows holders of a manufacturer permit to distribute the drug manufactured, made, produced, packed, packaged, repackaged, relabeled, or prepared to anyone other than the end user without the need to obtain a wholesale distributor permit; and creates a process for registration of nonresident manufacturers of prescription drugs. Amends § 2.2-4006, § 54.1-3307, § 54.1-3401, § 54.1-3410.2, § 54.1-3434, § 54.1-3434.1, § 54.1-3435, § 54.1-3435.01, § 54.1-3435.1, § 54.1-3437, of the Code of Virginia. Read the Bill »

Outcome

Bill Has Passed

History

DateAction
01/09/2016Committee
01/09/2016Prefiled and ordered printed; offered 01/13/16 16101731D
01/09/2016Referred to Committee on Health, Welfare and Institutions
01/14/2016Assigned to sub: Subcommittee Subcommittee #1
01/14/2016Assigned to sub: Subcommittee #1
01/14/2016Assigned HWI sub: Subcommittee #1
01/15/2016Impact statement from VDH (HB528)
01/19/2016Subcommittee recommends reporting (10-Y 0-N)
01/21/2016Reported from Health, Welfare and Institutions (22-Y 0-N) (see vote tally)
01/25/2016Read first time
01/26/2016Read second time and engrossed
01/27/2016Read third time and passed House BLOCK VOTE (99-Y 0-N)
01/27/2016VOTE: BLOCK VOTE PASSAGE (99-Y 0-N) (see vote tally)
01/28/2016Constitutional reading dispensed
01/28/2016Referred to Committee on Education and Health
02/15/2016Assigned Education sub: Health Professions
02/18/2016Reported from Education and Health with amendments (15-Y 0-N) (see vote tally)
02/19/2016Constitutional reading dispensed (39-Y 0-N) (see vote tally)
02/22/2016Read third time
02/22/2016Reading of amendments waived
02/22/2016Committee amendments agreed to
02/22/2016Engrossed by Senate as amended
02/22/2016Passed Senate with amendments (40-Y 0-N) (see vote tally)
02/23/2016Placed on Calendar
02/24/2016Senate amendments agreed to by House (99-Y 0-N)
02/24/2016VOTE: ADOPTION (99-Y 0-N) (see vote tally)
02/25/2016Enrolled
02/25/2016Bill text as passed House and Senate (HB528ER)
02/25/2016Impact statement from VDH (HB528ER)
02/25/2016Signed by Speaker
02/26/2016Signed by President
02/29/2016Enrolled Bill communicated to Governor on 2/29/16
02/29/2016G Governor's Action Deadline Midnight, March 7, 2016
03/04/2016G Approved by Governor-Chapter 221 (effective 7/1/16)
03/04/2016G Acts of Assembly Chapter text (CHAP0221)

Video

This bill was discussed on the floor of the General Assembly. Below is all of the video that we have of that discussion, 2 clips in all, totaling 42 seconds.

Transcript

This is a transcript of the video clips in which this bill is discussed.



Sen. Mark Obenshain (R-Harrisonburg): SO I WOULD ASK THE MEMBERS OF THE BODY TO VOTE NO ON THE MOTION TO RECOMMIT THIS BILL TO THE COMMITTEE ON COURTS OF JUSTICE.

[Unknown]: THANK YOU, SENATOR. THE QUESTION IS SHALL HOUSE BILL 628 BE RECOMMITTED TO THE COMMITTEE FOR COURTS. ALL THOSE IN FAVOR OF THE MOTION WILL SAY AYE, THOSE OPPOSED NO. THE AYES HAVE IT. THE BILL IS RECOMMITTED TO THE