Virginia Law

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Public Participation Guidelines [Repealed]Read all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[Repealed]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[Repealed]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[Repealed]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[Repealed]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[Repealed]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[Repealed]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[Repealed]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[Repealed]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[Repealed]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[Repealed]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[Repealed]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[Repealed]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

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[Repealed]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[Repealed]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[Repealed]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[Repealed]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[Repealed]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[Repealed]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[Repealed]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[Repealed]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[Repealed]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[Repealed]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[Repealed]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[Repealed]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[Repealed]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[Repealed]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[Repealed]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[Repealed]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[Repealed]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[Repealed]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 ProcessorsRead all

Part I

General Provisions

Section 10

Definitions

Section 20

Fees

Part II

Requirements for Practitioners and Patients

Section 30

Requirements for Practitioner Issuing a Certification

Section 40

Prohibited Practices for Practitioners

Section 50

Voluntary Registration of a Patient, Parent, Legal Guardian, or Registered Agent

Section 60

Denial of a Qualifying Patient, Parent, Legal Guardian, or Registered Agent Registration Application

Section 70

Reporting Requirements for Practitioners, Patients, Parents, Legal Guardians, or Registered Agents

Section 80

Proper Storage and Disposal of Cannabis ProductsBy Patients, Parents, Legal Guardians, or Registered Agents

Section 90

Revocation or Suspension of a Registered Agent RegistrationOr Invalidation of the Voluntary Registration of a Patient, Parent, or Legal Guardian

Part III

Application and Approval Process for Pharmaceutical Processors and Cannabis Dispensing Facilities

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 135

Application for and Granting of a Permit for a Cannabis Dispensing Facility

Section 136

Denial of a Cannabis Dispensing Facility Permit Application

Section 140

Notification of Changes by Pharmaceutical Processor or Cannabis Dispensing Facility

Section 150

Pharmaceutical Processor or Cannabis Dispensing Facility Closings; Going Out of Business; Change of Ownership

Section 160

Grounds for Action Against a Pharmaceutical Processor Permit or a Cannabis Dispensing Facility

Part IV

Requirements for Pharmaceutical Processor Personnel

Section 170

Pharmaceutical Processor or Cannabis Dispensing Facility Employee Licenses and Registrations

Section 180

Employee Training

Section 190

Pharmacy Technicians; Ratio; Supervision and Responsibility

Section 195

Responsibilities of the Responsible Party

Section 200

Responsibilities of the Pic

Part V

Operation of a Pharmaceutical Processor

Section 210

General Provisions

Section 215

Marketing and Advertising

Section 220

Pharmaceutical Processor or Cannabis Dispensing Facility Prohibitions

Section 230

Inventory Requirements

Section 240

Security Requirements

Section 250

Requirements for the Storage and Handling of Cannabis or Cannabis Products

Section 251

Wholesale Distribution of Cannabis Products, Bulk Cannabis Oil, Botanical Cannabis, and Usable Cannabis

Section 260

Recordkeeping Requirements

Section 270

Reportable Events; Security

Part VI

Cultivation, Production, and Dispensing of Cannabis Products

Section 280

Cultivation and Production of Cannabis Products

Section 281

Use of Hydrocarbon-Based Solvents or Other Flammable Solvents

Section 285

Registration of Products

Section 290

Labeling of Batch of Cannabis Products

Section 295

Labeling of Bulk Cannabis Oil, Botanical Cannabis, and Usable Cannabis

Section 300

Laboratory Requirements; Testing

Section 310

Dispensing of Cannabis Products

Section 320

Dispensing Error Review and Reporting; Quality Assurance Program

Section 321

Devices, Hemp-Based Cbd Products, and Inert Product Samples

Section 330

Disposal of Cannabis Products

FORMS

Forms (18VAC110-60)