Title of Regulation: 18VAC110-20. Regulations Governing the Practice of Pharmacy (amending 18VAC110-20-355).

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: July 17, 2013.

Effective Date: August 2, 2013.

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 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. The specific authority to control the sale and dispensing of prescription drugs is found in Chapters 33 (§ 54.1-3300 et seq.) and 34 (§ 54.1-3400 et seq.) of Title 54.1 of the Code of Virginia.

Purpose: The goal of the amended regulation is to protect the safety and efficacy of drugs dispensed to patients from automated counting devices in a manner that is reasonable and the least burdensome to pharmacies that use such devices.

The amended regulation is less burdensome and less costly for pharmacies that utilize automated counting devices. Most such devices are used for fast-moving drugs, so the requirement to allow the bins to run dry every 60 days to prevent expired drugs from being dispensed is not necessary to protect public health and safety unless there is a risk of a drug that has been recalled remaining in a bin and being dispensed to patients. Some states do not allow multiple lots to be placed in one bin, but the majority of states have no such requirement and no run dry requirement.

In modifying 18VAC110-20-355, the board considered safeguards that would ensure recalled drugs are not being dispensed to patients. If the technology of the device can ensure drugs in a particular lot have been cleared out of the machine, it is not necessary to dispose of all drugs in a bin to which a recalled lot has been added. If a particular device does not have such technology, and if multiple lots are in a bin, the drugs may have to be removed and not used for patient care when there is a recall on any of the lots within the last three months. Additionally, the regulation requires regular emptying and cleaning of the device to avoid an accumulation of drug residue that might affect the efficacy of the drugs or the accuracy of the dispensing.

Rationale for Using Fast-Track Process: The board has opted to use the fast-track process for two reasons: the action is consistent with the Governor's project to reform regulations that are unnecessarily burdensome, and there was no objection voiced during the NOIRA comment period.

Substance: The public safety concern with the use of automated counting devices is that if there is a recall on a lot number among the drugs that have been placed in a bulk bin, can the recalled drugs be completely removed from the device. Therefore, the amended regulation specifies emptying the device and disposing of drugs if one of multiple lots has been placed in the bin or cell in the last three months and it is known that a recalled lot remains in the bin. Exceptions to the requirement for disposal are included if there is a reliable means of proving that the drugs included in the recall are no longer in the bin or if the bin has been allowed to run dry since the recalled lot was placed in the bin. The intent of the regulation is to protect the public without unnecessarily requiring drugs to be disposed of and wasted. Since the run dry requirement is eliminated, a provision requiring emptying and cleaning of the bins in accordance with manufacturers specifications is added to alleviate any concerns about drug residue affecting functionality and quality assurance.

Issues: The primary advantage of the regulatory action is cost and time savings to pharmacies that are currently required to run dry cells or bins in automated counting devices. The purposes for the requirement can be accomplished with a less burdensome and costly regulation that assures recalled lots of drugs do not remain in the cell for dispensing. There are no disadvantages to the public.

There are no advantages or disadvantages to the Commonwealth.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. The Board of Pharmacy (Board) proposes to eliminate the current requirement that bulk bins in an automated counting device be run dry every 60 days. In addition, the Board proposes to specify that: 1) only if there is a drug recall within the last three months or if it is known that a recalled drug is in the device will it be required that drugs be removed, and 2) if the device has technology that ensures a particular lot has been cleared or if the bin has been allowed to run dry since the addition of the recalled lot, it will not be necessary to remove all drugs in the bin in the event of a recall.

Result of Analysis. The benefits likely exceed the costs for all proposed changes.

Estimated Economic Impact. Under the current regulations, if only one lot is added to a bin at one time, but a subsequent lot is added before the first has cleared, the bin is required to "run dry" where all product is completely removed prior to filling at least once every 60 days with a record made of the run dry dates. The Board proposes to repeal this mandate to have the pharmaceuticals completely removed prior to filling at least once every 60 days; but at the same the Board proposes to specify that:

In the event of a drug recall involving one of multiple lots placed in a bin of an automated counting device in the last three months or if a recalled drug is known to remain in the bin, all drugs shall be removed from the bin and not used for patient care. The removal of drugs from the bin is not required if:

a. The technology of the automated counting device can ensure drugs in a particular lot have been cleared; or

b. The bin has been run dry, with a record made of the run dry date, since the addition of the recalled lot number in which all drugs were completely removed prior to filling with a subsequent lot number.

The proposal to eliminate the "run dry" requirement will result in cost savings both in staff time consumed with meeting the current 60-day run-dry requirement and in the unnecessary loss of drugs that are removed every 60 days when the bin must be "run dry." Public safety is maintained by no longer requiring the removal of pharmaceuticals when there is no clear benefit, but requiring removal when there is a risk of recalled drugs being present. Thus, the proposed amendments produce a net benefit.

Businesses and Entities Affected. The proposed amendments affect the 1,760 pharmacies in Virginia that have a current license (permit).

Localities Particularly Affected. The proposed amendments do not disproportionately affect particular localities.

Projected Impact on Employment. The proposed amendments are unlikely to significantly affect employment.

Effects on the Use and Value of Private Property. The proposed amendments modestly reduce costs for pharmacies by eliminating the requirement that bulk bins in an automated counting device be "run dry" every 60 days.

Small Businesses: Costs and Other Effects. The proposal to eliminate the "run dry" requirement will result in cost savings for small businesses both in staff time consumed and in the unnecessary loss of drugs that are removed every 60 days when the bin must be run dry.

Small Businesses: Alternative Method that Minimizes Adverse Impact. The proposed amendments do not adversely affect small businesses.

Real Estate Development Costs. The proposed amendments do not affect real estate development costs.

Legal Mandate. The Department of Planning and Budget (DPB) has analyzed the economic impact of this proposed regulation in accordance with § 2.2-4007.04 of the Administrative Process Act and Executive Order Number 14 (10). Section 2.2-4007.04 requires that such economic impact analyses include, but need not be limited to, the projected number of businesses or other entities to whom the regulation would apply, the identity of any localities and types of businesses or other entities particularly affected, the projected number of persons and employment positions to be affected, the projected costs to affected businesses or entities to implement or comply with the regulation, and the impact on the use and value of private property. Further, if the proposed regulation has adverse effect on small businesses, § 2.2-4007.04 requires that such economic impact analyses include (i) an identification and estimate of the number of small businesses subject to the regulation; (ii) the projected reporting, recordkeeping, and other administrative costs required for small businesses to comply with the regulation, including the type of professional skills necessary for preparing required reports and other documents; (iii) a statement of the probable effect of the regulation on affected small businesses; and (iv) a description of any less intrusive or less costly alternative methods of achieving the purpose of the regulation. The analysis presented above represents DPB's best estimate of these economic impacts.

Agency's Response to Economic Impact Analysis: The Board of Pharmacy concurs with the economic impact analysis of the Department of Planning and Budget on proposed amended regulations for 18VAC110-20, Regulations Governing the Pharmacy, relating to "run-dry" requirements for automated counting devices.

Summary:

The regulatory action eliminates the current requirement in 18VAC110-20-355 that bulk bins in an automated counting device be "run dry" every 60 days to prevent expired drugs from being dispensed. If a drug recall occurs within the last three months or if it is known that a recalled drug is in the device, the amended regulation requires that all drugs be removed from the bin and not used for patient care. If the device has technology that ensures a particular drug lot has been cleared or if the bin has been allowed to "run dry" since the addition of the recalled drug lot, it will not be necessary to remove all drugs from the bin in the event of a recall. A requirement for cleaning and maintaining the automated counting device is included in the amendments to the regulation.

18VAC110-20-355. Pharmacy repackaging of drug; records required; labeling requirements.

A. Pharmacies in which bulk reconstitution of injectable, bulk compounding or the repackaging or prepackaging of drugs is performed shall maintain adequate control records for a period of one year or until the expiration, whichever is greater. The records shall show the name of the drug(s) used; strength, if any; date repackaged; quantity prepared; initials of the pharmacist verifying the process; the assigned lot or control number; the manufacturer's or distributor's name and lot or control number; and an expiration date.

B. The drug name; strength, if any; the assigned lot or control number or the manufacturer's or distributor's name and lot or control number; and an appropriate expiration date determined by the pharmacist in accordance with USP guidelines shall appear on any subsequently repackaged or reconstituted units.

C. Pharmacies using automated counting devices or dispensers in which drugs are removed from manufacturer's original packaging and placed in bulk bins shall comply with the following requirements:

1. A bin filling record shall be maintained, manually or in a computerized record for a period of one year from date of filling from which information can be readily retrieved, for each bin including:

a. The drug name and strength, if any;

b. The name of the manufacturer or distributor;

c. Manufacturer's control or lot number(s) and expiration date for all lots placed into the bin at the time of filling;

d. Any assigned lot number;

e. An expiration date determined according to USP guidelines for repackaging;

f. The date of filling; and

g. The pharmacist's initials verifying the accuracy of the process.

2. If more than one lot is added to a bin at the same time, the lot which expires first shall be used to determine the expiration date if shorter than a calculated date based on USP guidelines.

3. Each bin shall be labeled in such a manner as to cross-reference the information on the filling record with the correct expiration date.

4. If only one lot is added to a bin at one time, but a subsequent lot may be added before the first has cleared, the automated device shall be constructed to reasonably dispense the first lot before the second lot is dispensed, and the expiration date on the bin's label shall reflect the expiration date assigned to the earlier lot, and the bin shall be allowed to "run dry" where all product is completely removed prior to filling at least once every 60 days with a record made of the run dry dates.

5. In the event of a drug recall involving one of multiple lots placed in a bin of an automated counting device in the last three months or if a recalled drug is known to remain in the bin, all drugs shall be removed from the bin and not used for patient care. The removal of drugs from the bin is not required if:

a. The technology of the automated counting device can ensure drugs in a particular lot have been cleared; or

b. The bin has been "run dry," with a record made of the "run dry" date, since the addition of the recalled lot number in which all drugs were completely removed prior to filling with a subsequent lot number.

6. An automated counting device shall be cleaned and maintained in accordance with recommended manufacturer guidelines and specifications.

D. A pharmacy may return a dispensed drug to stock for redispensing that has never left the pharmacy premises or the control of the pharmacy delivery agent pursuant to § 54.1-3411.1 A 3 of the Code of Virginia under the following conditions:

1. An expiration date shall be placed on the label prior to returning the drug to stock. In the absence of stability data to the contrary, the date on the label may not exceed the expiration date on the manufacturer's container or one year from the date the drug was originally dispensed and placed in the prescription vial, whichever date is earlier.

2. The restocked drug shall be used to fill the next prescription received for that product. In the event that the drug is not dispensed prior to the new assigned expiration date, it shall be removed from working stock as expired, and disposed of in accordance with 18VAC110-20-210.

3. If there is no lot number on the label of a drug returned to stock or on the prescription records that can be cross-referenced from the prescription label, the drug shall be removed from stock upon any recall of that drug product and returned to the manufacturer or otherwise disposed of in accordance with 18VAC110-20-210.