Title of Regulation: 18VAC110-20. Regulations Governing the Practice of Pharmacy (amending 18VAC110-20-10, 18VAC110-20-400; adding 18VAC110-20-740 through 18VAC110-20-800).

Statutory Authority: § 54.1-2400 of the Code of Virginia.

Effective Dates: April 10, 2009, through October 6, 2010.

Pursuant to § 2.2-4011, the Board of Pharmacy requested an extension of the above-referenced emergency regulation to complete the requirements of the Administrative Process Act. The emergency regulations were published in 25:17 VA.R. 3018-3023 April 27, 2009 (http://register.dls.virginia.gov/vol25/iss17/v25i17.pdf).

Chapter 429 of the 2008 Acts of Assembly requires the Board of Pharmacy to promulgate regulations to establish a Prescription Drug Donation Program for accepting unused previously dispensed prescription drugs that meet certain criteria for redispensing to patients of free clinics. The second enactment of Chapter 429 required the board to promulgate regulations to implement the provisions of the act effective within 280 days of its enactment.

The board submitted the emergency regulations for Executive Branch review on September 25, 2008, and approval to publish those regulations was received April 9, 2009. Therefore, the emergency regulations did not become effective until April 10, 2009, and expired on April 9, 2010.

Simultaneously with publication of the emergency regulations, the board published a Notice of Intended Regulatory Action on April 27, 2009, to begin the process of promulgating a permanent replacement regulation. The Board of Pharmacy submitted the proposed replacement regulation on July 24, 2009; permission to publish the proposed regulation was granted on October 29, 2009, and it was submitted to the Registrar of Regulations that same day. Comment on the proposed regulations closed on January 22, 2010, and the board will adopt final regulations at its next scheduled meeting on March 9, 2010. In order to have had a replacement regulation in effect by April 9, 2010, it would have been necessary to submit the final regulation by February 10, 2010. Therefore, a six-month extension was requested to allow the permanent replacement regulation to become effective.

The Governor approved the department's request to extend the expiration date of the emergency regulation for six months as provided for in § 2.2-4011 D of the Code of Virginia. Therefore, the regulations will continue in effect through October 6, 2010.

Agency Contact: Elizabeth Scott Russell, RPh, Executive Director, Board of Pharmacy, 9960 Mayland Drive, Suite 300, Richmond, VA 23233-1463, telephone (804) 367-4456, FAX (804) 527-4472, or email scotti.russell@dhp.virginia.gov.