NOTICES OF INTENDED REGULATORY ACTION
Vol. 32 Iss. 9 - December 28, 2015

TITLE 16. LABOR AND EMPLOYMENT
Administrative Regulation for the Virginia Occupational Safety and Health Program
Notice of Intended Regulatory Action

Notice is hereby given in accordance with § 2.2-4007.01 of the Code of Virginia that the Safety and Health Codes Board intends to consider amending 16VAC25-60, Administrative Regulation for the Virginia Occupational Safety and Health Program, which contains rules and procedures under which the Commonwealth carries out its obligations, as prescribed by Title 40.1 of the Code of Virginia and the Virginia State Plan for Occupational Safety and Health, as approved by the U.S. Department of Labor. The proposed changes are intended to accommodate statutory changes to the Code of Virginia, strengthen anti-retaliation or "whistleblower" protections for both public and private sector employees, and specify the burden of proof threshold for Virginia Occupational Safety and Health (VOSH) Program cases that go to circuit court.

The agency intends to hold a public hearing on the proposed action after publication in the Virginia Register.

Statutory Authority: §§ 40.1-6 and 40.1-22 of the Code of Virginia.

Public Comment Deadline: January 27, 2016.

Agency Contact: John J. Crisanti, Planning and Evaluation Manager, Department of Labor and Industry, Main Street Centre, 600 East Main Street, Richmond, VA 23219, telephone (804) 786-4300, FAX (804) 786-8418, or email crisanti.john@dol.gov.

VA.R. Doc. No. R16-4561; Filed December 7, 2015, 11:26 a.m.
TITLE 18. PROFESSIONAL AND OCCUPATIONAL LICENSING
Regulations Governing the Practice of Pharmacy
Notice of Intended Regulatory Action

Notice is hereby given in accordance with § 2.2-4007.01 of the Code of Virginia that the Board of Pharmacy intends to consider amending 18VAC110-20, Regulations Governing the Practice of Pharmacy. In compliance with the second enactment clause of Chapter 300 of the 2015 Acts of the Assembly, the purpose of the proposed action is to adopt regulations to implement the requirement of law that facilities engaged in the compounding of sterile drugs and registered with the U.S. Secretary of Health and Human Services as outsourcing facilities must hold a permit to compound or ship compounded drugs into Virginia. The proposed amendments include (i) setting fees for approval of applications and renewal of permits and registration; (ii) specifying requirements for pharmacies that are or are not applicable to outsourcing facilities; (iii) establishing requirements for pharmacist supervision, recordkeeping, and renewal; and (iv) specifying that if a compounding pharmacy shares physical space with an outsourcing facility, the more stringent standards of good manufacturing practices are applicable.

The agency intends to hold a public hearing on the proposed action after publication in the Virginia Register.

Statutory Authority: §§ 54.1-2400 and 54.1-3307 of the Code of Virginia.

Public Comment Deadline: January 27, 2016.

Agency Contact: Caroline Juran, RPh, Executive Director, Board of Pharmacy, 9960 Mayland Drive, Suite 300, Richmond, VA 23233-1463, telephone (804) 367-4416, FAX (804) 527-4472, or email caroline.juran@dhp.virginia.gov.

VA.R. Doc. No. R16-4528; Filed December 7, 2015, 11:23 a.m.
TITLE 18. PROFESSIONAL AND OCCUPATIONAL LICENSING
Regulations for Practitioners of the Healing Arts to Sell Controlled Substances
Notice of Intended Regulatory Action

Notice is hereby given in accordance with § 2.2-4007.01 of the Code of Virginia that the Board of Pharmacy intends to consider amending 18VAC110-30, Regulations for Practitioners of the Healing Arts to Sell Controlled Substances. In compliance with the second enactment clause of Chapter 117 of the 2015 Acts of the Assembly, the purpose of the proposed action is to adopt regulations to implement the requirement of law that practitioners of the healing arts must dispense controlled substances in permitted facilities. The proposed amendments include (i) setting fees for approval of applications, renewal of permits, and reinstatement of lapsed permits and (ii) associating requirements for inspections, physical standards for the facility, and notification to the board with the facility permit rather than the individual licensee. The only proposed change in physical requirements is specificity about the availability of hot and cold water, which must be within 20 feet of the selling and storage area and not located within an examination room or restroom.

The agency intends to hold a public hearing on the proposed action after publication in the Virginia Register.

Statutory Authority: §§ 54.1-2400 and 54.1-3304.1 of the Code of Virginia.

Public Comment Deadline: January 27, 2016.

Agency Contact: Caroline Juran, RPh, Executive Director, Board of Pharmacy, 9960 Mayland Drive, Suite 300, Richmond, VA 23233-1463, telephone (804) 527-4416, FAX (804) 527-4472, or email caroline.juran@dhp.virginia.gov.

VA.R. Doc. No. R16-4532; Filed December 7, 2015, 11:22 a.m.