Administrative Code

Virginia Administrative Code
Title 18. Professional and Occupational Licensing
12/10/2019

Agency 110. Board of Pharmacy

Preface
Agency Summary
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Public Participation Guidelines [Repealed]Read all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[Repealed]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[Repealed]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[Repealed]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[Repealed]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[Repealed]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[Repealed]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[Repealed]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[Repealed]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[Repealed]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[Repealed]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[Repealed]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[Repealed]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
Section 10
Purpose
Section 20
Definitions
Section 30
Notification List
Section 40
Information to Be Sent to Persons on the Notification List
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 20
Regulations Governing the Practice of PharmacyRead all
Section 10
Definitions
Section 15
Criteria for Delegation of Informal Fact-Finding Proceedings to an Agency Subordinate
Section 20
Fees
Section 21
Public Address
Section 22
Application to Include E-Profile Number
Section 25
Unprofessional Conduct
Section 30
Requirements for Pharmacy Practical Experience
Section 40
Procedure for Gaining Practical Experience
Section 50
Curriculum and Approved Schools of Pharmacy
Section 60
Content of the Examination and Grades Required; Limitation on Admittance to Examination
Section 70
Requirements for Foreign-Trained Applicants
Section 75
Registration for Voluntary Practice by Out-of-State Licensees
Section 80
Renewal and Reinstatement of License
Section 90
Requirements for Continuing Education
Section 100
Approval of Continuing Education Programs
Section 101
Application for Registration As a Pharmacy Technician
Section 102
Criteria for Approval for Training Programs
Section 103
Examination
Section 104
Address of Record; Maintenance of Certificate
Section 105
Renewal and Reinstatement of Registration
Section 106
Requirements for Continued Competency
Section 110
Pharmacy Permits Generally
Section 111
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
Section 220
General Requirements for Pharmacies Providing Radiopharmaceutical Services
Section 230
[Repealed]
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]
Section 270
Dispensing of Prescriptions; Certification of Completed Prescriptions; Supervision of Pharmacy Technicians
Section 275
Delivery of Dispensed Prescriptions
Section 276
Central or Remote Processing
Section 280
Transmission of a Prescription Order by Facsimile Machine
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
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
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 420
Unit Dose Dispensing System
Section 425
Robotic Pharmacy Systems
Section 430
[Repealed]
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 Program
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
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
Section 570
Drugs in Infirmaries/First Aid Rooms
Section 580
Humane Societies and Animal Shelters
Section 590
Drugs in Correctional Facilities
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
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
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 30
Regulations for Practitioners of the Healing Arts to Sell Controlled SubstancesRead all
Section 10
Definitions
Section 15
Fees
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]
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
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
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
Section 250
Choice of Controlled Substance Supplier
Section 255
Purchase of Drugs
Section 260
Returning of Controlled Substances
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, Warehousers, and Third-Party Logistics ProvidersRead all
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 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
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 ProcessorsRead all
Section 10
Definitions
Section 20
Fees
Section 30
Requirements for Practitioner Issuing a Certification
Section 40
Prohibited Practices for Practitioners
Section 50
Registration of a Patient, Parent, or Legal Guardian
Section 60
Denial of a Qualifying Patient, Parent, or Legal Guardian Registration Application
Section 70
Reporting Requirements for Practitioners, Patients, Parents, or Legal Guardians
Section 80
Proper Storage and Disposal of Cannabidiol Oil or Thc-A Oil by Patients, Parents, or Legal Guardians
Section 90
Revocation or Suspension of a Qualifying Patient, Parent, or Legal Guardian Registration
Section 100
Publication of Notice for Submission of Applications
Section 110
Application Process for Pharmaceutical Processor Permits
Section 120
Conditional Approval
Section 130
Granting of a Pharmaceutical Processor Permit
Section 140
Notification of Changes by Pharmaceutical Processor
Section 150
Pharmaceutical Processor Closings; Going Out of Business; Change of Ownership
Section 160
Grounds for Action Against a Pharmaceutical Processor Permit
Section 170
Pharmaceutical Processor Employee Licenses and Registrations
Section 180
Employee Training
Section 190
Pharmacy Technicians; Ratio; Supervision and Responsibility
Section 200
Responsibilities of the Pic
Section 210
General Provisions
Section 220
Pharmaceutical Processor Prohibitions
Section 230
Inventory Requirements
Section 240
Security Requirements
Section 250
Requirements for the Storage and Handling of Cannabis, Cannabidiol Oil, or Thc-A Oil
Section 260
Recordkeeping Requirements
Section 270
Reportable Events; Security
Section 280
Cultivation and Production of Cannabidiol Oil or Thc-A Oil
Section 285
Registration of Products
Section 290
Labeling of Batch of Cannabidiol Oil or Thc-A Oil Products
Section 300
Laboratory Requirements; Testing
Section 310
Dispensing of Cannabidiol Oil or Thc-A Oil
Section 320
Dispensing Error Review and Reporting; Quality Assurance Program
Section 330
Disposal of Cannabidiol Oil or Thc-A Oil
FORMS
Forms (18VAC110-60)


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