Title of Regulation: 18VAC110-20. Regulations Governing the Practice of Pharmacy (amending 18VAC110-20-590).

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

Public Hearing Information: No public hearings are scheduled.

Public Comment Deadline: August 23, 2017.

Effective Date: September 7, 2017.

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.

Basis: Regulations are promulgated under (i) the general authority of § 54.1-2400 of the Code of Virginia, which provides the Board of Pharmacy the authority to promulgate regulations to administer the regulatory system and (ii) a specific mandate of Chapter 82 of the 2016 Acts of Assembly.

The statutory authority for the board to promulgate regulations to regulate the security and integrity of drugs and devices is found in § 54.1-3307 of the Code of Virginia.

Purpose: The purpose of the amended regulation is to conform Virginia regulations to advice given the Department of Corrections about the disposition of unused or expired drugs. The federal Drug Enforcement Administration (DEA) does not allow controlled substances (Schedules II through V) that have already been dispensed to a patient to be returned to the pharmacy to be redispensed to another patient. Currently, regulations for drugs in correctional facilities do permit such returns, if the facilities comply with provisions of 19VAC110-20-400 regarding drug returns. The prohibition on returning controlled substances after they have been dispensed to a patient is intended to protect the health and safety of the public and the integrity of the drug chain, so patients are assured of the efficacy and safety of the drugs they receive.

Rationale for Using Fast-Track Rulemaking Process: The change in disposition of scheduled drugs within correctional facilities is necessary to conform to advice from the DEA and is not controversial. It does not affect the public or the pharmacy community in general.

Substance: In order to comply with the DEA, 18VAC110-20-590 regarding drugs in correctional facilities is amended to require unused or expired drugs in Schedules II through V to be destroyed at the facility rather than being returned to the provider pharmacy. To ensure the integrity of the destruction process, the regulations contain requirements for witnessing the destruction and for recordkeeping.

Issues: There are no advantages or disadvantages to the public or the agency. The Department of Corrections will have clarity in the rules for disposition, so state regulations are consistent with DEA rules for correctional institutions.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. As mandated by federal regulation,¹ the Board of Pharmacy (Board) proposes to amend its Regulations Governing the Practice of Pharmacy to require correctional facilities to destroy all Schedule II through V drugs onsite rather than allowing them to be returned to the dispensing pharmacy.

Result of Analysis. Benefits likely outweigh costs for all proposed changes.

Estimated Economic Impact. Current Board regulation allows correctional facilities to return unused or discontinued prescription drugs to the dispensing pharmacy which then would destroy them. However, federal Drug Enforcement Administration (DEA) regulation does not allow such returns for Schedule II through V drugs. In order to conform this regulation to DEA rules, the Board now proposes to amend it so that it is clear that correctional facilities are required to destroy unused or discontinued Schedule II through V drugs onsite. Additionally, the Board proposes to specify the manner and timing of such drug destruction.² Further, the Board proposes to specify that drug destruction must be performed by a nurse, pharmacist, or physician and must be witnessed by a separate person who is a nurse supervisor, pharmacist or physician.

Correctional facilities will likely only be affected by these changes in Board regulation if they are currently non-compliant with DEA regulations. Affected facilities would likely incur some small time costs involved with destroying drugs onsite but those time costs are likely outweighed by the benefits, for both correctional facilities and their provider pharmacies, of being in compliance with DEA rules. For example, and in particular, such compliance will ensure that pharmacies do not run afoul of federal rules that could result in revocation of the DEA registration that allows them to dispense drugs.

Businesses and Entities Affected. These proposed regulatory changes apply to all correctional facilities in the Commonwealth as well as the provider pharmacies that serve them.

Localities Particularly Affected. No locality is likely to be particularly affected by these proposed regulatory changes.

Projected Impact on Employment. These proposed regulatory changes are unlikely to affect employment in the Commonwealth.

Effects on the Use and Value of Private Property. These proposed regulatory changes are unlikely to affect the use or value of private property in the Commonwealth.

Real Estate Development Costs. These proposed regulatory changes are unlikely to affect real estate development costs in the Commonwealth.

Small Businesses:

Definition. Pursuant to § 2.2-4007.04 of the Code of Virginia, small business is defined as "a business entity, including its affiliates, that (i) is independently owned and operated and (ii) employs fewer than 500 full-time employees or has gross annual sales of less than $6 million."

Costs and Other Effects. No small businesses are likely to incur any additional costs on account of these proposed regulatory changes.

Alternative Method that Minimizes Adverse Impact. No small businesses are likely to incur any additional costs on account of these proposed regulatory changes.

Adverse Impacts: 

Businesses. No businesses are likely to incur any additional costs on account of these proposed regulatory changes.

Localities. Jails that are run by localities, and are not already in compliance with DEA rules, may incur some small time costs for destroying prescription drugs onsite. These costs would likely be very minimal.

Other Entities. No other entities are likely to be adversely affected by these proposed changes.

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¹ 21 CFR 1317.15(b) which can be found at https://www.deadiversion.usdoj.gov/21cfr/cfr/1317/subpart_a.htm#15

² Drugs must be destroyed in a manner that makes them unrecoverable and within 30 days of their discontinued use.

Agency's Response to Economic Impact Analysis: The Board of Pharmacy concurs with the analysis of the Department of Planning and Budget.

Summary:

The amendments require a correctional facility to destroy unused or expired drugs in Schedules II through V at the facility and establish requirements for witnessing the destruction and for recordkeeping.

18VAC110-20-590. Drugs in correctional facilities.

A. All prescription drugs at any correctional facility shall be subject to the following conditions:

1. Notwithstanding the allowances in subsections B, C, and D of this section, prescription drugs shall be obtained only on an individual prescription basis.

2. All prepared drugs shall be maintained in a suitable locked storage area with only the person responsible for administering the drugs having access.

3. Complete and accurate records shall be maintained of all drugs received, administered and discontinued. The administration record shall show the:

a. Patient name;

b. Drug name and strength;

c. Number of dosage units received;

d. Prescriber's name; and

e. Date, time and signature of the person administering the individual dose of drug.

4. All unused or discontinued drugs shall be sealed and the amount in the container at the time of the sealing shall be recorded on the drug administration record. Such Schedule VI drugs shall be returned to the provider pharmacy or to a secondary pharmacy along with the drug administration record, a copy of the drug administration record, or other form showing substantially the same information, within 30 days of discontinuance.

a. The provider or secondary pharmacy shall conduct random audits of returned drug administration records for accountability.

b. The drug administration records shall be filed in chronological order by the provider or secondary pharmacy and maintained for a period of one year or, at the option of the facility, the records may be returned by the pharmacy to the facility.

c. Drugs may be returned to pharmacy stock in compliance with the provisions of 18VAC110-20-400.

d. Other drugs shall be disposed of or destroyed by the provider pharmacy in accordance with local, state, and federal regulations.

5. Alternatively, drugs for destruction may be forwarded by a pharmacist directly from the correctional facility to a returns company after After performing the audit required by subdivision 4 a of this subsection and ensuring the proper maintenance of the administration records, drugs in Schedules II through V shall be destroyed at the site of the correctional facility using a method of destruction that renders the drug unrecoverable.

a. The destruction shall be performed by a nurse, pharmacist, or physician and witnessed by the nurse supervisor, a pharmacist, or a physician.

b. Destruction of drugs shall occur within 30 days of discontinuance.

c. A complete and accurate record of the drugs destroyed shall be made. The original of the record of destruction shall be signed and dated by the persons witnessing the destruction and maintained at the correctional facility for a period of two years. A copy of the destruction record shall be maintained at the provider pharmacy for a period of two years.

B. Emergency and stat-drug box. An emergency box and a stat-drug box may be prepared for a correctional facility served by the pharmacy pursuant to 18VAC110-20-540 and 18VAC110-20-550 provided that the facility employs one or more full-time physicians, registered nurses, licensed practical nurses, or physician assistants.

C. A correctional facility may maintain a stock of intravenous fluids, irrigation fluids, sterile water, and sterile saline to be accessed only by those persons licensed to administer drugs and shall be administered only by such persons pursuant to a valid prescription or lawful order of a prescriber. Such stock shall be limited to a listing to be determined by the provider pharmacist in consultation with the medical and nursing staff of the institution.

D. Except for drugs in an emergency box, stat-drug box, or a stock of intravenous fluids, irrigation fluids, sterile water, and sterile saline, prescription drugs, including but not limited to vaccines, may be floor-stocked only at a medical clinic or surgery center that is part of a correctional facility and that is staffed by one or more prescribers during the hours of operation, provided the clinic first obtains a controlled substances registration and complies with the requirements of 18VAC110-20-690, 18VAC110-20-700, 18VAC110-20-710, and 18VAC110-20-720.