LIS

Virginia Law

Administrative Code

Virginia Administrative Code
Title 18. Professional And Occupational Licensing
11/21/2024

Agency 110. Board of Pharmacy

Preface

VAC AGENCY NO. 110

BOARD OF PHARMACY

AGENCY SUMMARY

The Board of Pharmacy is a licensing and regulatory board housed within the Department of Health Professions. For the statutory authority of the boards within the department, see Subtitle III (§ 54.1-2400 et seq.) of Title 54.1 of the Code of Virginia.

The board is authorized by Chapters 29 (§ 54.1-2900 et seq.), 33 (§ 54.1-3300 et seq.), and 34 (§ 54.1-3400 et seq.) of Title 54.1 of the Code of Virginia to license pharmacists; to register pharmacy technicians; to permit pharmacies, outsourcing facilities, and third-party logistics providers; to register nonresident pharmacies, nonresident outsourcing facilities, and nonresident manufacturers; to regulate the manufacturing, dispensing, selling, distributing, processing, compounding, or disposal of drugs and devices; to register persons prescribing or doing research in controlled substances; to modify the statutory classifications of controlled substances; to prescribe standards for special packaging; to promulgate regulations respecting equipment, sanitation, quality control, and safeguards against diversion and otherwise carry out the drug control statutes; and, jointly with the Board of Medicine, to promulgate regulations to facilitate the development and implementation of safe and effective collaborative agreements between practitioners of the healing arts and pharmacists. The board is authorized to license and regulate the dispensing of controlled substances by practitioners of the healing arts and to issue permits to the facilities from which they dispense. The board regulates the storage, handling, and distribution of prescription drugs by wholesale distributors, medical equipment suppliers, third-party logistics providers, and warehousers to prevent the diversion of prescription drugs. 

The board may embargo products and may impose a monetary penalty for violations not prosecuted through Chapter 34 (§ 54.1-3400 et seq.) of Title 54.1 or Chapter 7 (§ 18.2-247 et seq.) of Title 18.2 of the Code of Virginia. 

Board regulations and guidance as well as contact information for the board are available through the board's website at https://www.dhp.virginia.gov/Boards/Pharmacy/.

Rev. 07/2024

Chapter 10
Public Participation Guidelines [Repealed]Read all
Section 10
[Repealed]
Section 20
[Repealed]
Section 30
[Repealed]
Section 40
[Repealed]
Section 50
[Repealed]
Section 60
[Repealed]
Section 70
[Repealed]
Section 80
[Repealed]
Section 90
[Repealed]
Section 100
[Repealed]
Section 110
[Repealed]
Section 120
[Repealed]
Chapter 11
Public Participation GuidelinesRead all
Part I
Purpose and Definitions
Section 10
Purpose
Section 20
Definitions
Part II
Notification of Interested Persons
Section 30
Notification List
Section 40
Information to Be Sent to Persons on the Notification List
Part III
Public Participation Procedures
Section 50
Public Comment
Section 60
Petition for Rulemaking
Section 70
Appointment of Regulatory Advisory Panel
Section 80
Appointment of Negotiated Rulemaking Panel
Section 90
Meetings
Section 100
Public Hearings on Regulations
Section 110
Periodic Review of Regulations
Chapter 15
Regulations for Delegation to an Agency SubordinateRead all
Section 10
Criteria for Delegation of Informal Fact-Finding Proceeding to an Agency Subordinate
Chapter 20
Regulations Governing the Practice of PharmacyRead all
Part I
General Provisions
Section 10
Definitions
Section 15
[Repealed]
Section 20
Fees
Section 21
[Repealed]
Section 22
[Repealed]
Section 25
Unprofessional Conduct
Section 30
[Repealed]
Section 40
[Repealed]
Section 50
[Repealed]
Section 60
[Repealed]
Section 70
[Repealed]
Section 75
[Repealed]
Section 80
[Repealed]
Section 90
[Repealed]
Section 100
[Repealed]
Section 101
[Repealed]
Section 102
[Repealed]
Section 103
[Repealed]
Section 104
[Repealed]
Section 105
[Repealed]
Section 106
[Repealed]
Part II
Pharmacies
Section 110
Pharmacy Permits Generally
Section 111
Pharmacy Technicians
Section 112
Supervision of Pharmacy Technicians
Section 120
Special or Limited-Use Pharmacy Permits
Section 121
Innovative Program Approval
Section 130
Pharmacy Closings; Going Out of Business; Change of Ownership
Section 135
Change of Hours in an Existing Pharmacy
Section 140
New Pharmacies, Acquisitions, and Changes to Existing Pharmacies
Section 150
Physical Standards for All Pharmacies
Section 160
Sanitary Conditions
Section 170
Required Minimum Equipment or Resources
Section 180
Security System
Section 190
Prescription Department Enclosures; Access to Prescription Department
Section 200
Storage of Drugs, Devices, and Controlled Paraphernalia; Expired Drugs
Section 210
Disposal of Drugs by Pharmacies
Section 211
Disposal of Drugs by Authorized Collectors
Section 215
Outsourcing Facilities
Part III
Nuclear Pharmacies
Section 220
General Requirements for Pharmacies Providing Radiopharmaceutical Services
Section 230
[Repealed]
Part IV
Drug Inventory and Records
Section 240
Manner of Maintaining Records, Prescriptions, Inventory Records
Section 250
Automated Data Processing Records of Prescriptions
Section 255
Other Dispensing Records
Section 260
[Repealed]
Part V
Prescription Order and Dispensing Standards
Section 270
Dispensing of Prescriptions; Certification of Completed Prescriptions
Section 275
Delivery of Dispensed Prescriptions
Section 276
Central or Remote Processing
Section 280
Transmission of a Prescription Order by Facsimile Device
Section 285
Electronic Transmission of Prescriptions from Prescriber to Pharmacy
Section 286
Chart Orders for Outpatients
Section 290
Dispensing of Schedule II Drugs
Section 300
[Repealed]
Section 310
Partial Dispensing of Schedule II Prescriptions
Section 320
Dispensing or Refilling of Schedules III Through VI Prescriptions
Part VI
Labeling and Packaging Standards for Prescriptions
Section 321
Compounding
Section 322
Placement of Chemicals in Schedule I
Section 323
Scheduling for Conformity with Federal Law or Rule
Section 330
Labeling of Prescription As to Content and Quantity
Section 340
Packaging Standards for Dispensed Prescriptions
Section 350
Special Packaging
Section 355
Pharmacy Repackaging of Drug; Records Required; Labeling Requirements
Part VII
Standards for Prescription Transactions
Section 360
Issuing a Copy of a Prescription That Can Be Filed or Refilled
Section 370
[Repealed]
Section 390
Kickbacks, Fee-Splitting, Interference with Supplier
Section 391
Prescription Blanks
Section 395
Purchase of Drugs
Section 400
Returning of Drugs and Devices
Section 410
Permitted Physician Licensed by the Board
Section 411
[Repealed]
Section 412
[Repealed]
Section 413
[Repealed]
Section 414
[Repealed]
Section 415
[Repealed]
Section 416
[Repealed]
Section 417
(Reserved.)
Section 418
Continuous Quality Improvement Programs
Section 419
(Reserved.)
Part VIII
Unit Dose Dispensing Systems
Section 420
Unit Dose Dispensing System
Section 425
Robotic Pharmacy Systems
Section 430
[Repealed]
Part IX
Pharmacy Services to Hospitals
Section 440
Responsibilities of the Pharmacist-In-Charge
Section 450
After-Hours Access to the Pharmacy
Section 460
Floor Stock Drugs; Proof of Delivery; Distribution Records
Section 470
Emergency Room
Section 480
[Repealed]
Section 490
Automated Devices for Dispensing and Administration of Drugs
Section 500
Licensed Emergency Medical Services (EMS) Agencies
Section 505
Use of Radio-Frequency Identification
Section 510
Identification for Medical Intern or Resident Prescription Form in Hospitals
Section 515
Remote Prescription Order Processing for Hospitals and Long-Term Care Facilities
Part X
Pharmacy Services to Long-Term Care Facilities
Section 520
Drugs in Long-Term Care Facilities
Section 530
Pharmacy's Responsibilities to Long-Term Care Facilities
Section 535
Repackaging of Already Dispensed Prescriptions
Section 536
Prescription Drugs Sent Outside the Facility
Section 540
Emergency Drug Kit
Section 550
Stat-Drug Box
Section 555
Use of Automated Dispensing Devices
Section 560
Floor Stock
Part XI
Other Institutions and Facilities
Section 570
Drugs in Infirmaries or First-Aid Rooms
Section 580
Animal Shelters
Section 590
Drugs in Correctional Facilities
Part XII
Exempted Stimulant or Depressant Drugs and Chemical Preparations
Section 600
Excluded Substances
Section 610
Exempted Chemical Preparations
Section 620
Exempted Prescription Products
Section 621
Exempted Anabolic Steroid Products
Section 622
Excluded Veterinary Anabolic Steroid Implant Products
Part XIII
Medical Equipment Suppliers
Section 630
Issuance of a Permit As a Medical Equipment Supplier
Section 640
[Repealed]
Section 650
[Repealed]
Section 660
[Repealed]
Section 680
Medical Equipment Suppliers
Part XVI
Controlled Substances Registration for Other Persons or Entities
Section 685
Definitions for Controlled Substances Registration
Section 690
Persons or Entities Authorized or Required to Obtain a Controlled Substances Registration
Section 700
Requirements for Supervision for Controlled Substances Registrants
Section 710
Requirements for Storage and Security for Controlled Substances Registrants
Section 720
Requirements for Recordkeeping
Section 725
Repackaging by a CSB, BHA, or PACE Site
Section 726
Criteria for Approval of Repackaging Training Programs
Section 727
Pharmacists Repackaging for Clients of a CSB, BHA, or PACE
Section 728
Drugs for Immediate Treatment in Crisis Stabilization Units
Section 730
Requirements for Practitioner of Medicine or Osteopathy in Free Clinics
Section 735
Requirements for Dispensing of Naloxone by Trained Individuals
Section 740
Drug Donation Sites
Section 750
Eligible Drugs
Section 760
Procedures for Collecting Eligible Donated Drugs
Section 770
Procedure for Transferring Donated Prescription Drugs
Section 780
Procedure for Dispensing Donated Prescription Drugs
Section 790
Procedures for Disposing of Donated Prescription Drugs
Section 800
Records
FORMS
Forms (18VAC110-20)
DIBR
Documents Incorporated by Reference (18VAC110-20)
Chapter 21
Regulations Governing the Licensure of Pharmacists and Registration of Pharmacy TechniciansRead all
Part I
General Provisions
Section 10
Definitions
Section 20
Fees
Section 30
Current Name and Address
Section 31
Application to Include E-Profile Number
Section 40
Unprofessional Conduct
Section 45
Kickbacks, Fee-Splitting, Interference with Supplier
Section 46
Initiation of Treatment by a Pharmacist
Part II
Licensure Requirement for Pharmacists
Section 50
Requirements for Pharmacy Practical Experience
Section 60
Procedure for Gaining Practical Experience
Section 70
Curriculum and Approved Schools of Pharmacy
Section 80
Content of the Examination and Grades Required; Limitation on Admittance to Examination
Section 90
Requirements for Foreign-Trained Applicants
Section 100
Registration for Voluntary Practice by Out-of-State Licensees
Part III
Requirements for Renewal or Reinstatement of Licensure
Section 110
Renewal and Reinstatement of License
Section 120
Requirements for Continuing Education
Section 130
Approval of Continuing Education Programs
Section 135
Registration As a Pharmacy Technician Trainee
Part IV
Requirements for Pharmacy Technician Registration
Section 140
Application for Registration As a Pharmacy Technician
Section 141
Requirements for Pharmacy Technician Training
Section 150
Criteria for Approval for Training Programs (Effective Until July 1, 2022)
Section 160
[Repealed]
Section 170
Renewal and Reinstatement of Registration
Section 180
Requirements for Continued Competency
FORMS
Forms (18VAC110-21)
Chapter 30
Regulations for Practitioners of the Healing Arts to Sell Controlled SubstancesRead all
Part I
Definitions and Fees
Section 10
Definitions
Section 15
Fees
Part II
Licensure and Permit Requirements
Section 20
Application for Licensure
Section 21
Application for Facility Permit
Section 30
Renewal of License or Permit
Section 35
[Repealed]
Section 40
Acts to Be Performed by the Licensee
Section 50
Licensees Ceasing to Sell Controlled Substances; Inventory Required Prior to Disposal
Section 60
[Repealed]
Part III
Inspection Requirements, Standards, and Security for Storage Areas; Disposal of Controlled Substances
Section 70
Practitioner in Charge in a Permitted Facility
Section 80
Inspection and Notice Required
Section 90
Physical Standards
Section 100
Access to Selling Area
Section 110
Minimum Equipment
Section 120
Safeguards Against Diversion of Controlled Substances
Section 130
Selling Area Enclosures
Section 140
Prescriptions Awaiting Delivery
Section 150
Expired Controlled Substances; Security
Section 160
Disposal of Schedule II Through VI Controlled Substances
Part IV
Written Prescription and Record Keeping Standards
Section 170
Sign and Written Prescription Requirements
Section 180
Manner of Maintaining Inventory Records for Licensees Selling Controlled Substances
Section 190
Manner of Maintaining Records for Schedule II Through VI Controlled Substances Sold
Section 200
Automated Data Processing Records of Sale
Part V
Packaging, Repackaging and Label Standards
Section 210
Repackaging of Controlled Substances; Records Required; Labeling Requirements
Section 220
Labeling of Prescription As to Content and Quantity
Section 230
Packaging Standards for Controlled Substance Sold
Section 240
Special Packaging
Part VI
Patient's Choice of Supplier, Purchase of Drugs, and Return of Controlled Substances
Section 250
Choice of Controlled Substance Supplier
Section 255
Purchase of Drugs
Section 260
Returning of Controlled Substances
Part VII
Grounds for Disciplinary Action
Section 270
Grounds for Disciplinary Action
FORMS
Forms (18VAC110-30)
DIBR
Documents Incorporated by Reference (18VAC110-30)
Chapter 40
Regulations Governing Collaborative Practice AgreementsRead all
Section 10
Definitions
Section 20
Signed Authorization for an Agreement
Section 30
Approval of Protocols Outside the Standard of Care
Section 40
Content of an Agreement and Treatment Protocol
Section 50
Record Retention
Section 60
Rescindment or Alteration of the Agreement
Section 70
Compliance with Statutes and Regulations
Chapter 50
Regulations Governing Wholesale Distributors, Manufacturers, Third-Party Logistics Providers, and WarehousersRead all
Part I
General Provisions
Section 10
Definitions
Section 20
Fees
Section 30
Application; Location of Business; Inspection Required
Section 40
Safeguards Against Diversion of Drugs
Section 50
Storage
Section 51
Disposal of Drugs by Authorized Collectors
Section 55
Delivery of Schedule VI Devices
Part II
Wholesale Distributors and Third-Party Logistics Providers
Section 60
Special or Limited-Use Licenses
Section 70
Minimum Required Information
Section 80
Minimum Licensure and Permitting Qualifications and Eligibility; Responsible Party
Section 90
Minimum Requirements for the Storage, Handling, Transport, and Shipment of Prescription Drugs
Section 100
Examination of Drug Shipments and Accompanying Documents
Section 110
Returned, Damaged, and Counterfeit Drugs; Investigations
Section 120
Policies and Procedures
Section 130
Recordkeeping
Section 140
Due Diligence
Part III
Manufacturers
Section 150
Good Manufacturing Practices
Section 160
[Repealed]
Section 170
[Repealed]
Section 180
[Repealed]
Section 190
[Repealed]
FORMS
Forms (18VAC110-50)
DIBR
Documents Incorporated by Reference (18VAC110-50)
Chapter 60
Regulations Governing Pharmaceutical Processors [Repealed]Read all
Part I
General Provisions [Repealed]
Section 10
[Repealed]
Section 20
[Repealed]
Part II
Requirements for Practitioners and Patients [Repealed]
Section 30
[Repealed]
Section 40
[Repealed]
Section 50
[Repealed]
Section 60
[Repealed]
Section 70
[Repealed]
Section 80
[Repealed]
Section 90
[Repealed]
Part III
Application and Approval Process for Pharmaceutical Processors and Cannabis Dispensing Facilities [Repealed]
Section 100
[Repealed]
Section 110
[Repealed]
Section 120
[Repealed]
Section 130
[Repealed]
Section 135
[Repealed]
Section 136
[Repealed]
Section 140
[Repealed]
Section 150
[Repealed]
Section 160
[Repealed]
Part IV
Requirements for Pharmaceutical Processor Personnel [Repealed]
Section 170
[Repealed]
Section 180
[Repealed]
Section 190
[Repealed]
Section 195
[Repealed]
Section 200
[Repealed]
Part V
Operation of a Pharmaceutical Processor [Repealed]
Section 210
[Repealed]
Section 215
[Repealed]
Section 220
[Repealed]
Section 230
[Repealed]
Section 240
[Repealed]
Section 250
[Repealed]
Section 251
[Repealed]
Section 260
[Repealed]
Section 270
[Repealed]
Part VI
Cultivation, Production, and Dispensing of Cannabis Products [Repealed]
Section 280
[Repealed]
Section 281
[Repealed]
Section 285
[Repealed]
Section 290
[Repealed]
Section 295
[Repealed]
Section 300
[Repealed]
Section 310
[Repealed]
Section 320
[Repealed]
Section 321
[Repealed]
Section 330
[Repealed]
FORMS
[Repealed]

Website addresses provided in the Virginia Administrative Code to documents incorporated by reference are for the reader's convenience only, may not necessarily be active or current, and should not be relied upon. To ensure the information incorporated by reference is accurate, the reader is encouraged to use the source document described in the regulation.

As a service to the public, the Virginia Administrative Code is provided online by the Virginia General Assembly. We are unable to answer legal questions or respond to requests for legal advice, including application of law to specific fact. To understand and protect your legal rights, you should consult an attorney.