TABLE OF CONTENTS

 

CHAPTER Ph 100  ORGANIZATIONAL RULES

          PART Ph 101  PURPOSE AND SCOPE

                  Section Ph 101.01  Purpose and Scope

 

          PART Ph 102  DEFINITIONS

                  Section Ph 102.01  Statutory Definitions Adopted

                  Section Ph 102.02  Other Definitions

 

          PART Ph 103  AGENCY ORGANIZATION

                  Section Ph 103.01  Composition

                  Section Ph 103.02  Officers

                  Section Ph 103.03  Address

                  Section Ph 103.04  Meetings

 

          PART Ph 104  PUBLIC INFORMATION

                  Section Ph 104.01  Records

                  Section Ph 104.02  Copies

                  Section Ph 104.03  Lists of Licensees/Registrants


 

CHAPTER Ph 200  PRACTICE AND PROCEDURE

          PART Ph 201  INTRODUCTION AND DEFINITIONS

                  Section Ph 201.01  Procedure Governed

                  Section Ph 201.02  Definitions

 

          PART Ph 202  FILING AND SERVICE OF DOCUMENTS

                  Section Ph 202.01  Filing of Documents

                  Section Ph 202.02  Subscription and Veracity of Documents

                  Section Ph 202.03  Service of Documents

                  Section Ph 202.04  Voluntary Production of Information

                  Section Ph 202.05  Motions to Compel Production of Information and Documents

 

          PART Ph 203  HEARINGS AND PROCEEDINGS

                  Section Ph 203.01  Mandatory Pre-Hearing Disclosure of Witnesses and Exhibits

                  Section Ph 203.02  Representatives

                  Section Ph 203.03  Computation of Time

                  Section Ph 203.04  Change in Allowed Times

                  Section Ph 203.05  Recess and Adjournment

                  Section Ph 203.06  Waiver

                  Section Ph 203.07  Docket

                  Section Ph 203.08  Consolidation

                  Section Ph 203.09  Severance

 

          PART Ph 204  ADJUDICATIVE PROCEEDINGS

                  Section Ph 204.01  Applicability

                  Section Ph 204.02  Place of an Adjudicative Proceeding

                  Section Ph 204.03  Commencement of Adjudicative Proceeding

                  Section Ph 204.04  Notice

                  Section Ph 204.05  Continuances

                  Section Ph 204.06  Emergency Orders

                  Section Ph 204.07  Intervention

                  Section Ph 204.08  Access to Board Records

                  Section Ph 204.09  Filing Requirements

                  Section Ph 204.10  Stipulations

                  Section Ph 204.11  Evidence

                  Section Ph 204.12  Withdrawal of Presiding Officer

                  Section Ph 204.13  Hearing Procedure

                  Section Ph 204.14  Burden of Proof

                  Section Ph 204.15  Decisions

                  Section Ph 204.16  Failure to Appear

                  Section Ph 204.17  Informal Settlement

 

          PART Ph 205  REHEARINGS AND APPEALS

                  Section Ph 205.01  Motion for Rehearing

                  Section Ph 205.02  Action on Motion for Rehearing

                  Section Ph 205.03  Burden of Proof

                  Section Ph 205.04  Decisions

 

          PART Ph 206  DECLARATORY RULINGS

                  Section Ph 206.01  Petitions

                  Section Ph 206.02  Action on Petition

 

          PART Ph 207  RULEMAKING PETITIONS

                  Section Ph 207.01  Rulemaking Petitions

                  Section Ph 207.02  Incomplete Rulemaking Petitions

                  Section Ph 207.03  Action on Rulemaking Petition

 

          PART Ph 208  RULEMAKING HEARINGS

                  Section Ph 208.01  Public Notice of Rulemaking Hearing

                  Section Ph 208.02  Presiding Officer

                  Section Ph 208.03  Order of the Rulemaking Hearing

                  Section Ph 208.04  Oral Comment

                  Section Ph 208.05  Written Comment

 

          PART Ph 209  EXPLANATION OF ADOPTED RULES

                  Section Ph 209.01  Requests for Explanation of Adopted Rules

                  Section Ph 209.02  Contents of Explanation


 

CHAPTER Ph 300  LICENSING OF PHARMACISTS AND PHARMACIES

          PART Ph 301  LICENSING OF PHARMACISTS BY EXAMINATION

                  Section Ph 301.01  Application

                  Section Ph 301.02  Additional Requirements

                  Section Ph 301.03  Required Examinations

                  Section Ph 301.04  Required Examination Score

                  Section Ph 301.05  Notice and Election of Re-examination

                  Section Ph 301.06  Issuance or Denial of Original License

 

          PART Ph 302  LICENSING OF PHARMACISTS BY RECIPROCITY

                  Section Ph 302.01  Reciprocity

                  Section Ph 302.02  Application

                  Section Ph 302.03  Requirements

                  Section Ph 302.04  Reciprocity Application Time Limitation

                  Section Ph 302.05  NH MPJE Examination Required Scores and Fees

                  Section Ph 302.06  NH MPJE Re-Examination Notice and Election

                  Section Ph 302.07  Reciprocity License Issuance or Denial

 

          PART Ph 303  PHARMACY PERMIT OPTIONS

                  Section Ph 303.01  Licensing the Entire Store Area

                  Section Ph 303.02  Licensing Only the Prescription Department

 

          PART Ph 304  PHARMACY PERMIT APPLICATION

                  Section Ph 304.01  Obtaining and Filing a Permit Application

                  Section Ph 304.02  Application Contents

 

          PART Ph 305  PHARMACY PERMIT PROCEDURE

                  Section Ph 305.01  Pharmacy Permit Conference

                  Section Ph 305.02  Site Inspection for Pharmacy Permit

                  Section Ph 305.03  Issuance and Denial of Pharmacy Permit

 

          PART Ph 306  PHARMACY PERMITS - CHANGES IN SUPPORTING DATA

                  Section Ph 306.01  Pharmacy Ownership Transfer

                  Section Ph 306.02  Reporting Changes

                  Section Ph 306.03  Change in Pharmacy Name or Location - Prohibited

                  Section Ph 306.04  Renovations

Section Ph 306.05  Special Permit Provisions for Sudden Termination of Pharmacist-In-Charge (PIC)

 

          PART Ph 307  RENEWAL AND REPLACEMENT PHARMACY PERMITS

                  Section Ph 307.01  Renewal Permits Required

                  Section Ph 307.02  Renewal Application Where Obtained and Filed

                  Section Ph 307.03  Renewal Application Contents and When Filed

                  Section Ph 307.04  Renewal Application Deficiencies

                  Section Ph 307.05  Issuance or Denial of Renewal Permit

                  Section Ph 307.06  Replacement Permit Application and Contents

 

          PART Ph 308  REVOCATION AND SUSPENSION OF A PHARMACY PERMIT

                  Section Ph 308.01  Grounds for Revocation or Suspension

                  Section Ph 308.02  Effect of Revocation

                  Section Ph 308.03  Effect of Suspension

                  Section Ph 308.04  Voluntary Surrender When Permitted

                  Section Ph 308.05  Hearing

                  Section Ph 308.06  Other Examination Fees - Repealed

 

          PART Ph 309  STANDARDS OF PRACTICE FOR MANUFACTURERS, WHOLESALERS AND DISTRIBUTORS – Moved to Ph 1000


 

CHAPTER Ph 400  CONTINUED STATUS

          PART Ph 401  RENEWAL AND REPLACEMENT LICENSES

                  Section Ph 401.01  Obtaining and Filing Renewal Applications

                  Section Ph 401.02  Renewal Application Contents and Filing Deadline

                  Section Ph 401.03  Renewal Application Deficiencies

                  Section Ph 401.04  Renewal License Issuance and Denial

                  Section Ph 401.05  Duplicate/Replacement Original Certificate of Licensure or Renewal License - Issuance

                  Section Ph 401.06  Reinstatement

                  Section Ph 401.07  Gold Certificates

 

          PART Ph 402  DISCIPLINARY MATTERS

                  Section Ph 402.01  Effect of Revocation

                  Section Ph 402.02  Effect of Suspension

                  Section Ph 402.03  Voluntary Surrender of License

                  Section Ph 402.04  Hearing

 

          PART Ph 403  CONTINUING EDUCATION REQUIREMENTS

                  Section Ph 403.01  Definitions

                  Section Ph 403.02  Renewal Requirements

                  Section Ph 403.03  Excess CEU's

                  Section Ph 403.04  CEU's from Other States

                  Section Ph 403.05  Credit for Instructors of Continuing Education

                  Section Ph 403.06  Postgraduate Pharmacy Curricula

                  Section Ph 403.07  Audio/Visual Continuing Education

                  Section Ph 403.08  Waiver

                  Section Ph 403.09  Military Personnel

                  Section Ph 403.10  Reinstatement

                  Section Ph 403.11  Penalty

                  Section Ph 403.12  In-State Approved Providers of Continuing Pharmacy Education

                  Section Ph 403.13  Continuing Education Advisory Council Membership

 

          PART Ph 404  STANDARDS FOR COMPOUNDING AND DISPENSING STERILE AND NON-STERILE PHARMACEUTICALS

                  Section Ph 404.01  Purpose and Scope

                  Section Ph 404.02  Definitions

                  Section Ph 404.03  Non-Sterile Pharmaceutical Compounding

                  Section Ph 404.04  Regulatory Requirements for Sterile Compounding

                  Section Ph 404.05  Sterile Quality Requirements

                  Section Ph 404.06  Compounding Environment

                  Section Ph 404.07  Engineering Controls

                  Section Ph 404.08  Compounding Procedures

                  Section Ph 404.09  Records Management

 

          PART Ph 405  STANDARDS OF PRACTICE FOR NUCLEAR/RADIOLOGIC PHARMACY

                  Section Ph 405.01  Purpose

                  Section Ph 405.02  Definitions

                  Section Ph 405.03  General Requirements for Pharmacies Providing Radiopharmaceutical Services

                  Section Ph 405.04  Minimum Equipment


 

CHAPTER Ph 500  ETHICAL STANDARDS

          PART Ph 501 CODE OF ETHICS

                  Section Ph 501.01  Standards of Conduct


 

CHAPTER Ph 600  LIMITED RETAIL DRUG DISTRIBUTOR

          PART Ph 601  LICENSING OF LIMITED RETAIL DRUG DISTRIBUTORS

                        Section Ph 601.01  License Required

                  Section Ph 601.02  Obtaining and Filing a License Application

                  Section Ph 601.03  Application Contents

                  Section Ph 601.04  Consultant Pharmacist

                  Section Ph 601.05  Changes in Supporting Information

                  Section Ph 601.06  Renewal Applications

                  Section Ph 601.07  Temperature

                  Section Ph 601.08  Quarantine

                  Section Ph 601.09  Space

                  Section Ph 601.10  Security

                  Section Ph 601.11  Dispensing Practices

                  Section Ph 601.12  Deliveries

                  Section Ph 601.13  Access to Drug Supply

                  Section Ph 601.14  Dispensing Records

                  Section Ph 601.15  Prescription Labels

                  Section Ph 601.16  Labeling Exemption

                  Section Ph 601.17  Violations

 

          PART Ph 602  MEDICAL GASES

                  Section Ph 602.01  Biennial Registration Required

                  Section Ph 602.02  Medical Gas Supplier Requirements


 

CHAPTER Ph 700  STANDARDS OF PRACTICE

          PART Ph 701  REFERENCES AND DEFINITIONS

                  Section Ph 701.01  Applicability

                  Section Ph 701.02  Definitions

                  Section Ph 701.03  References

 

          PART Ph 702  RECORDS AND REPORTS

                  Section Ph 702.01  Recordkeeping Requirements

                  Section Ph 702.02  Prepackaging of Drugs

                  Section Ph 702.03  Controlled Drug Losses

                  Section Ph 702.04  Automated Data Processing Systems

                  Section Ph 702.05  Federal DEA #222 Order Forms

                  Section Ph 702.06  Inspection Report

 

          PART Ph 703  DISPENSING OF DRUGS AND DEVICES

                  Section Ph 703.01  Presence of Pharmacists

                  Section Ph 703.02  Schedule V Controlled Substances

                  Section Ph 703.03  Prescriptions

                  Section Ph 703.04  Transfer of Prescriptions

                  Section Ph 703.05  Drug Product Selection

                  Section Ph 703.06  Return of Drugs and Devices

                  Section Ph 703.07  Prescription Pick-up and Delivery

                  Section Ph 703.08  Dispensing Adulterated or Misbranded Drugs

                  Section Ph 703.09  Prescription Refill Limitations

                  Section Ph 703.10  Prescription Refill – Interim Supply

                  Section Ph 703.11  Acts Prohibited

 

          PART Ph 704  PHARMACEUTICAL CARE STANDARDS

                  Section Ph 704.01  Patient Records

                  Section Ph 704.02  Prospective Drug Review

                  Section Ph 704.03  Patient Counseling

 

          PART Ph 705  DISPOSAL AND DESTRUCTION OF CONTROLLED DRUGS

                  Section Ph 705.01  Controlled Drug Destruction

                  Section Ph 705.02  Request for Destruction

                  Section Ph 705.03  Board Authorized Controlled Drug Destruction

                  Section Ph 705.04  Controlled Drug Destruction by the Board of Pharmacy

                  Section Ph 705.05  Record of Controlled Drug Destruction

                  Section Ph 705.06  Exemption

 

          PART Ph 706  ADMINISTRATIVE FINES

                  Section Ph 706.01  Liability for Administrative Fines

                  Section Ph 706.02  Severity of Fine


CHAPTER Ph 800  PHARMACY TECHNICIANS

          PART Ph 801  PURPOSE AND SCOPE

                  Section Ph 801.01  Purpose and Scope

 

          PART Ph 802  DEFINITIONS

                  Section Ph 802.01  Definitions

 

          PART Ph 803  REQUIREMENTS FOR REGISTERED PHARMACY TECHNICIANS

                  Section Ph 803.01  Registered Pharmacy Technician Qualifications

                  Section Ph 803.02  Application Procedures for Registered Pharmacy Technicians

 

          PART Ph 804  REGISTERED PHARMACY TECHNICIAN RENEWALS

                  Section Ph 804.01  Renewal Requirements for Registered Pharmacy Technicians

 

          PART Ph 805  ONGOING REQUIREMENTS FOR REGISTERED PHARMACY TECHNICIANS

                  Section Ph 805.01  Change in Registration Information for Registered Pharmacy Technicians

                  Section Ph 805.02  Penalty

 

          PART Ph 806  REVOCATION, DENIAL, AND REINSTATEMENT OF REGISTERED PHARMACY TECHNICIANS

                  Section Ph 806.01  Effect of Revocation and Denial for Registered Pharmacy Technicians

                  Section Ph 806.02  Reinstatement of a Registered Pharmacy Technician

 

          PART Ph 807  REGISTERED PHARMACY TECHNICIANS – STANDARDS OF PRACTICE

                  Section Ph 807.01  Determination of a Registered Pharmacy Technician’s Duties

                  Section Ph 807.02  Registered Pharmacy Technician Duties

 

          PART Ph 808  REQUIREMENTS FOR CERTIFIED PHARMACY TECHNICIANS

                  Section Ph 808.01  Certified Pharmacy Technician Qualifications

                  Section Ph 808.02  Application Procedures for Certified Pharmacy Technicians

 

          PART Ph 809  CERTIFIED PHARMACY TECHNICIAN RENEWALS

                  Section Ph 809.01  Renewal Requirements for Certified Pharmacy Technicians

 

          PART Ph 810  ONGOING REQUIREMENTS FOR CERTIFIED PHARMACY TECHNICIANS

                  Section Ph 810.01  Changes in Certification Information for Certified Pharmacy Technicians

                  Section Ph 810.02  Continuing Education Requirements for Certified Pharmacy Technicians

                  Section Ph 810.03  Excess Continuing Education Requirements for Certified Pharmacy Technicians

                  Section Ph 810.04  Penalty

 

          PART Ph 811  REVOCATION, DENIAL, AND REINSTATEMENT OF CERTIFIED PHARMACY TECHNICIANS

                  Section Ph 811.01  Effect of Revocation and Denial for a Certified Pharmacy Technician

                  Section Ph 811.02  Reinstatement of a Pharmacy Technician Certification

 

          PART 812  CERTIFIED PHARMACY TECHNICIANS – STANDARDS OF PRACTICE

                  Section Ph 812.01  Determination of a Certified Pharmacy Technician’s Duties

                  Section Ph 812.02  Certified Pharmacy Technician’s Duties


 

CHAPTER Ph 900  MAIL-ORDER/NON-RESIDENT PHARMACY

          PART Ph 901  PURPOSE AND SCOPE

                  Section Ph 901.01  Scope

 

          PART Ph 902  DEFINITIONS

                  Section Ph 902.01  Telepharmacy Services

                  Section Ph 902.02  Mail-Order Pharmacy

 

          PART Ph 903  REGISTRATION

                  Section Ph 903.01  Application

 

          PART Ph 904  REGISTRATIONS – CHANGES IN SUPPORTING DATA

                  Section Ph 904.01  Reporting Changes

 

          PART Ph 905  REVOCATION AND DENIAL

                  Section Ph 905.01  Effect of Revocation and Denial

 

          PART Ph 906  RENEWAL OF REGISTRATIONS

                  Section Ph 906.01  Renewal Registrations Required

                  Section Ph 906.02  Renewal Application Where Obtained and Filed

                  Section Ph 906.03  Renewal Application Contents and When Filed

                  Section Ph 906.04  Failure to Comply

 

          PART Ph 907  CONDITIONS OF REGISTRATION

                  Section Ph 907.01  Compliance


 

CHAPTER Ph 1000  STANDARDS OF PRACTICE FOR MANUFACTURERS, WHOLESALERS AND DISTRIBUTORS

          PART Ph 1001  LICENSING

                  Section Ph 1001.01  License Required

                  Section Ph 1001.02  Obtaining and Filing a License Application

                  Section Ph 1001.03  Application Contents

 

          PART Ph 1002  OPERATIONS

                  Section Ph 1002.01  Storage Conditions

                  Section Ph 1002.02  Facilities

                  Section Ph 1002.03  Security

                  Section Ph 1002.04  Recordkeeping

                  Section Ph 1002.05  Inspections

                  Section Ph 1002.06  Written Policies and Procedures

                  Section Ph 1002.07  Returned Goods

                  Section Ph 1002.08  Handling Recalls

                  Section Ph 1002.09  Responsibility for Operation

                  Section Ph 1002.10  Compliance with State and Federal Law

                  Section Ph 1002.11  Violations

                  Section Ph 1002.12  Reporting Changes

                  Section Ph 1002.13  Discontinuance of Business

                  Section Ph 1002.14  Disposition of Drugs and Records

                  Section Ph 1002.15  Distributing Adulterated or Misbranded Drugs


CHAPTER Ph 1100  COLLABORATIVE PHARMACY PRACTICE

          PART Ph 1101  PURPOSE

                  Section Ph 1101.01  Purpose

 

          PART Ph 1102  DEFINITIONS

                  Section Ph 1102.01  Attending Practitioner

                  Section Ph 1102.02  Collaborative Pharmacy Practice

                  Section Ph 1102.03  Collaborative Pharmacy Practice Agreement

                  Section Ph 1102.04  Board

 

          PART Ph 1103  COLLABORATIVE PHARMACIST QUALIFICATIONS AND APPLICATION

                  Section Ph 1103.01  Qualifications

                  Section Ph 1103.02  Attending Practitioner Qualifications

 

PART Ph 1104  APPLICATION AND SUPPORTING DOCUMENTATION

                  Section Ph 1104.01  Application

 

          PART Ph 1105  COLLABORATIVE PRACTICE AGREEMENTS AND INFORMED CONSENT

                  Section Ph 1105.01  Collaborative Practice Agreements

                  Section Ph 1105.02  Practice Under a Collaborative Practice Agreement

                  Section Ph 1105.03  Audits

 


CHAPTER Ph 1200  CENTRAL PRESCRIPTION PROCESSING

          PART Ph 1201  PURPOSE AND SCOPE

                  Section Ph 1201.01  Purpose

                  Section Ph 1201.02  Scope

 

          PART Ph 1202  DEFINITIONS

                  Section 1202.01  Central Fill Pharmacy

                  Section 1202.02  Central Prescription Processing

                  Section 1202.03  Central Processing Pharmacy

                  Section 1202.04  Claims Adjudication

                  Section 1202.05  Dispensing Pharmacy

                  Section 1202.06  Intake Pharmacy

 

          PART Ph 1203  CENTRAL PRESCRIPTION PROCESSING

                  Section 1203.01  General Requirements for Engaging in Central Prescription Processing

                  Section 1203.02  Policy and Procedure Manual Required

                  Section 1203.03  Patient Counseling

                  Section 1203.04  Prohibitions and Limitations

                  Section 1203.05  Record Keeping


CHAPTER Ph 1300  ADMINISTRATION OF VACCINES

          PART Ph 1301  PURPOSE AND SCOPE

                  Section Ph 1301.01  Purpose

                  Section Ph 1301.02  Scope

 

          PART Ph 1302  DEFINITIONS

                  Section Ph 1302.01  Administer

                  Section Ph 1302.02  Certified Pharmacy Technician

                  Section Ph 1302.03  Licensed Pharmacist

                  Section Ph 1302.04  Pharmacy Intern

                  Section Ph 1302.05  Practitioner or Licensed Practitioner

 

          PART Ph 1303  ADMINISTRATION OF VACCINES QUALIFICATIONS AND APPLICATION

                  Section Ph 1303.01  Qualifications

                  Section Ph 1303.02  Application

 

          PART Ph 1304  ADMINISTRATION OF VACCINES PROCEDURAL AND RECORDKEEPING REQUIREMENTS

                  Section Ph 1304.01  Vaccine Administration Requirements

                  Section Ph 1304.02  Recordkeeping


CHAPTER Ph 1400  UNUSED PRESCRIPTION DRUG PROGRAM RULES

          PART Ph 1401  PURPOSE

                  Section Ph 1401.01  Purpose

 

          PART Ph 1402  DEFINITIONS

                  Section Ph 1402.01  Abandoned Drug

                  Section Ph 1402.02  Agent

                  Section Ph 1402.03  Charitable Provider

                  Section Ph 1402.04  Dispense

                  Section Ph 1402.05  Donate

                  Section Ph 1402.06  Eligible Prescription Drug (EPD)

                  Section Ph 1402.07  Manifest

                  Section Ph 1402.08  Pharmacy

                  Section Ph 1402.09  Practitioner

                  Section Ph 1402.10  Program Pharmacist

                  Section Ph 1402.11  Redispense

                  Section Ph 1402.12  Underinsured

                  Section Ph 1402.13  Uninsured

 

          PART Ph 1403  ELIGIBILITY TO DONATE PRESECRIPTION DRUGS (EDP) AND MEDICAL DEVICES

                  Section Ph 1403.01  Eligible Donating Entities

                  Section Ph 1403.02  Unused Prescription Property

                  Section Ph 1403.03  Conditions Required for Unused Prescription Drugs

 

          PART Ph 1404  ELIGIBILITY TO ACCEPT DONATIONS (EAD)

                  Section Ph 1404.01  Eligible Accepting Entities

 

          PART Ph 1405  ELIGIBLITY TO REDISPENSE

                  Section Ph 1405.01  Eligible Redispensing Entities

 

          PART Ph 1406  PROGRAM PHARMACIST RESPONSIBILITIES

                  Section Ph 1406.01  Program Pharmacist

 

          PART Ph 1407  ELIGIBLE PRESCRIPTION DRUG FORMULARY

                  Section Ph 1407.01  Formulary

 

          PART Ph 1408  REQUIREMENTS FOR PHARMACIES DISPENSING UNUSED PRESCRIPTION DRUGS

                  Section Ph 1408.01  Dispensing Requirements

 

          PART Ph 1409  RESPONSIBILITIES OF CHARITABLE PROVIDERS

                  Section Ph 1409.01  Charitable Providers

                  Section Ph 1409.02  Labeling

                  Section Ph 1409.03  Handling Fee

                  Section Ph 1409.04  Recordkeeping

 

          PART Ph 1410  FORMS

                  Section Ph 1410.01  Transfer Manifests

 

          PART Ph 1411  PARTICIPANT IMMUNITY

                  Section Ph 1411.01  Participant Immunity

 

          PART Ph 1412  VIOLATIONS

                  Section Ph 1412.01  Violations of the Unused Prescription Drug Program


 

CHAPTER Ph 1500  NEW HAMPSHIRE CONTROLLED DRUG PRESCRIPTION HEALH AND SAFETY PROGRAM

          PART Ph 1501  PURPOSE

                  Section Ph 1501.01  Purpose

 

          PART Ph 1502  DEFINITIONS

                  Section Ph 1502.01  Definitions

 

          PART Ph 1503  REGISTRATION OF PRESCRIBERS AND DISPENSERS

                  Section Ph 1503.01  Registration of Prescribers and Dispensers

 

          PART Ph 1504  REQUIREMENTS FOR DISPENSERS

                  Section Ph 1504.01  Reporting of Controlled Substances Dispensed

                  Section Ph 1504.02  Waivers

                  Section Ph 1504.03  Extensions

 

          PART Ph 1505  ACCESS TO PRESCRIPTION DRUG MONITORINIG INFORMATION

                  Section Ph 1505.01  Patient Access

                  Section Ph 1505.02  Prescriber and Dispenser Access

                  Section Ph 1505.03  Law Enforcement Access

                  Section Ph 1505.04  Regulatory Board Access

                  Section Ph 1505.05  Other Access

 

          PART Ph 1506  REVIEW AND REPORTING OF PRESCRIPTION DRUG MONITORING INFORMATION

                  Section Ph 1506.01  Review of Program Data

                  Section Ph 1506.02  Reporting of Program Data


CHAPTER Ph 1600  PHARMACY INTERNS

          PART Ph 1601  PURPOSE AND SCOPE

                  Section Ph 1601.01  Purpose and Scope

 

          PART Ph 1602  DEFINITIONS

                  Section Ph 1602.01  Definitions

 

          PART Ph 1603  IDENTIFICATION

                  Section Ph 1603.01  Identification

         

          PART Ph 1604  REGISTRATION

                  Section Ph 1604.01  Application

 

          PART Ph 1605  REGISTRATIONS – CHANGES IN SUPPORTING DATA

                  Section Ph 1605.01  Reporting Changes

 

          PART Ph 1606  PHARMACY INTERNS – STANDARDS OF PRACTICE

                  Section Ph 1606.01  Responsibilities and Duties

 

          PART Ph 1607  REVOCATION AND DENIAL

                  Section Ph 1607.01  Effect of Revocation and Denial

 

          PART Ph 1608  RENEWAL OF REGISTRATIONS

                  Section Ph 1608.01  Renewal Registrations Required

                  Section Ph 1608.02  Renewal Application Where Obtained and Filed

                  Section Ph 1608.03  Renewal Application Contents and When Filed

                  Section Ph 1608.04  Reinstatement

 

CHAPTER Ph 1700  CONTINUOUS QUALITY IMPROVEMENT

          PART Ph 1701  PURPOSE AND SCOPE

                  Section Ph 1701.01  Purpose

                  Section Ph 1701.02  Scope

 

          PART Ph 1702  DEFINITIONS

                  Section Ph 1702.01  Definitions

 

          PART Ph 1703  PROGRAM REQUIREMENTS

                  Section Ph 1703.01  General Requirements

 

          PART Ph 1704  CONFIDENTIALITY OF QUALITY-RELATED EVENT REPORTS

                  Section Ph 1704.01  Availability of Quality-Related Event Reports

 

          PART Ph 1705  CONTINUOUS QUALITY IMPROVEMENT MEETINGS

                  Section Ph 1705.01  Requirements for Continuous Quality Improvement Meetings

 

          PART Ph 1706  SUMMARIZATION DOCUMENT

                  Section Ph 1706.01  Requirements for the Summarization Document

 

CHAPTER Ph 1800  LICENSED ADVANCED PHARMACY TECHNICIANS

          PART Ph 1801  PURPOSE AND SCOPE

                  Section Ph 1801.01  Purpose

                  Section Ph 1801.02  Scope

 

          PART Ph 1802  DEFINITIONS

                  Section Ph 1802.01  Definitions

          PART Ph 1803  INITIAL LICENSE

                  Section Ph 1803.01  Initial Application for Pharmacy Technician

                  Section Ph 1803.02  Processing of Applications

 

          PART Ph 1804  ONGOING REQUIREMENTS

                  Section Ph 1804.01  Reporting Changes

 

          PART Ph 1805  REVOCATION, SUSPENSION AND OTHER SANCTIONS

                  Section Ph 1805.01  Misconduct

                  Section Ph 1805.02  Revocation, Suspension, or Nonrenewal of National Certification

                  Section Ph 1805.03  Disciplinary Action and Sanctions

 

          PART Ph 1806  RENEWAL OF LICENSES

                  Section Ph 1806.01  Renewal of License Required

                  Section Ph 1806.02  Renewal Application Where Obtained and Filed

                  Section Ph 1806.03  Renewal Application Contents and When Filed

                  Section Ph 1806.04  Continuing Education Requirements for Licensed Advanced Pharmacy Technician

                  Section Ph 1806.05  Excess CEUs

 

          PART Ph 1807  REINSTATEMENT OF A SUSPENDED, REVOKED, VOLUNTARILY SURRENDERED, OR LAPSED LICENSE

                  Section Ph 1807.01  Reinstatement

 

          PART Ph 1808  LICENSED ADVANCED PHARMACY TECHNICIANS – STANDARDS OF PRACTICE

                  Section Ph 1808.01  Responsibilities

                  Section Ph 1808.02  Licensed Advanced Pharmacy Technician’s Duties

 

          PART Ph 1809  ADVANCED PHARMACY TECHNICIAN ADMINISTRATION OF VACCINES, QUALIFICATIONS, AND APPLICATION

                  Section Ph 1809.01  Qualifications

                  Section Ph 1809.02  Application

                  Section Ph 1809.03  Required Documents

                  Section Ph 1809.04  Vaccine Administration Requirements

                  Section Ph 1809.05  Recordkeeping

 

CHAPTER Ph 1900 - RESERVED


CHAPTER Ph 2000  LICENSING OF OUTSOURCING FACILITIES IDENTIFIED AS 503B FACILITIES BY THE UNITED STATES FOOD AND DRUG ADMINISTRATION

 

          PART Ph 2001  PURPOSE AND SCOPE

                  Section Ph 2001.01  Purpose and Scope

 

          PART Ph 2002  DEFINITIONS

                  Section 2002.01  Statutory Definitions Adopted

                  Section 2002.02  Other Definitions

 

          PART Ph 2003  STANDARDS OF PRACTICE FOR OUTSOURCING FACILITIES

                  Section 2003.01  Standards of Practice and Requirements for Outsourcing Facilities

                  Section 2003.02  License Required

                  Section 2003.03  Obtaining and Filing a License Application

                  Section 2003.04  Application Contents

                  Section 2003.05  Additional Requirements

                  Section 2003.06  Issuance, Denial and Revocation of License

 

          PART Ph 2004  NOTIFICATION REQUIRMENTS

                  Section Ph 2004.01  Reporting Changes

                  Section Ph 2004.02  Notice of Disciplinary Action

 

          PART Ph 2005  RENEWAL LICENSES

                  Section Ph 2005.01  Renewal Permits Required

                  Section Ph 2005.02  Renewal Application Where Obtained and Filed

                  Section Ph 2005.03  Renewal Application Contents and When Filed

                  Section Ph 2005.04  Renewal Application Deficiencies

                  Section Ph 2005.05  Issuance and Denial of Renewal License

 

          PART Ph 2006  POLICIES, PROCEDURES AND RECORDKEEPING

                  Section Ph 2006.01  Written Policies and Procedures

                  Section Ph 2006.02  Responsibility for Operation

                  Section Ph 2006.03  Returned Goods

                  Section Ph 2006.04  Handling Recalls

                  Section Ph 2006.05  Recordkeeping

                  Section Ph 2006.06  Inspections

 

          PART Ph 2007  DISPENSING AND DISTRIBUTIION REQUIREMENTS

                  Section Ph 2007.01  Dispensing and Distribution Requirements

 

          PART Ph 2008  LEGAL REQUIREMENTS

                  Section Ph 2008.01  Compliance with State and Federal Law


 

CHAPTER Ph 2100  INSPECTIONS

          PART Ph 2101  AUTHORITY AND SCOPE

                  Section Ph 2101.01  Board Authority for Inspections

                  Section Ph 2101.02  Scope

 

          PART 2102  DEFINITIONS

                  Section Ph 2102.01  Definitions

 

          PART 2103  PRE-INSPECTION REQUIREMENTS

                  Section Ph 2103.01  License Pre-Inspection Duties for Pharmacies

 

          PART 2104  INSPECTION FREQUENCY

                  Section Ph 2104.01  Scheduling

                  Section Ph 2104.02  Inspection Timeframes

 

          PART Ph 2105  RISK LEVEL INSPECTIONS

                  Section Ph 2105.01  Risk Level Assignment

 

          PART Ph 2106  SELF-INSPECTIONS

                  Section Ph 2106.01  Self-Inspection Requirements

                  Section Ph 2106.02  Required Self-Inspections by Risk Level

                  Section Ph 2106.03  Self-Inspection for Change of the Pharmacist-in-Charge

 

          PART Ph 2107  INSPECTION PROCESS FOR PRACTITIONERS

                  Section Ph 2107.01  Inspection Practices

                  Section Ph 2107.02  Performance of Inspections

                  Section Ph 2107.03  Inspection Frequency for Practitioners

                  Section Ph 2107.04  Category I: High Risk

                  Section Ph 2107.05  Category II: Medium Risk

                  Section Ph 2107.06  Category III: Low Risk

 

          PART Ph 2108  INSPECTION REPORTS

                  Section Ph 2108.01  Inspections

                  Section Ph 2108.02  Inspection Report Requirements

 

          PART Ph 2109  VIOLATION AND VIOLATION NOTICES

                  Section Ph 2109.01  Violation Notices

                  Section Ph 2109.02  Minor Violations

                  Section Ph 2109.03  Major Violations

                  Section Ph 2109.04  Prescription Drug Monitoring Program Violation Notifications

                  Section Ph 2109.05  Administrative Fines

                  Section Ph 2109.06  Prescription Monitoring Program Audit

                  Section Ph 2109.07  Minor Violation Schedule

                  Section Ph 2109.08  Major Violation Schedule


CHAPTER Ph 2200  PHARMACY BOARD INVESTIGATIONS

          PART Ph 2201  DEFINITIONS

                  Section Ph 2201.01  Definitions

 

          PART Ph 2202  PURPOSE AND SCOPE

                  Section Ph 2201.01  Purpose

                  Section Ph 2201.02  Scope

 

          PART Ph 2203  CONSUMER COMPLAINTS

                  Section Ph 2203.01  Consumer Complaints

 

          PART Ph 2204  RESPONSES

                  Sections Ph 2204.01  Quality Related Event Reports

 

          PART Ph 2205  INVESTIGATIONS

                  Section Ph 2205.01  Licensees Subject to Investigations

                  Section Ph 2205.02  Investigations of a Complaint

                  Section Ph 2205.03  Follow Up to Investigations

                  Section Ph 2205.04  Cost of the Investigation

 

          PART Ph 2206  INVESTIGATION REPORTS

                  Section Ph 2206.01  Reports of Investigation

                  Section Ph 2206.02  Notification of Violations

                  Section Ph 2206.03  Prescription Drug Monitoring Program Investigations

 

          PART Ph 2207  DISCIPLINARY ACTION

                  Section Ph 2207.01  Pharmacy Board Action

                  Section Ph 2207.02  Administrative and Disciplinary Fines


CHAPTER Ph 2300  INSTITUTIONAL PHARMACY PRACTICE

          PART Ph 2301  PRACTICES

                  Section Ph 2301.01  Definitions

                  Section Ph 2301.02  Permitting

                  Section Ph 2301.03  Practice Standards

                  Section Ph 2301.04  Environment

                  Section Ph 2301.05  Drug Security

                  Section Ph 2301.06  Access to the Pharmacy

                  Section Ph 2301.07  Drug Control In Ambulatory Patient Treatment Areas

                  Section Ph 2301.08  Investigational Drugs

                  Section Ph 2301.09  Purchase of Drugs


CHAPTER Ph 2400  PHARMACIST INITIATION AND DISPENSING OF HORMONAL CONTRACEPTIVES

          PART Ph 2401  PURPOSE, SCOPE, AND COOPERATION

                  Section Ph 2401.01  Purpose

                  Section Ph 2401.02  Scope

                  Section Ph 2401.03  Cooperation

 

          PART Ph 2402  DEFINITIONS

                  Section Ph 2402.01  Definitions

 

          PART Ph 2403  PHARMACIST REQUIREMENTS FOR CERTIFICATION

                  Section Ph 2403.01  Pharmacist Requirements

 

          PART Ph 2404  PROCEDURES FOR PRACTICE

                  Section Ph 2404.01  Initiation and Dispensing Procedure

                  Section Ph 2404.02  Recordkeeping Procedures

 

          PART Ph 2405  STANDARDS OF PRACTICE

                  Section Ph 2405.01  Patient Age Requirements

                  Section Ph 2505.02  Pharmacist Standards of Practice

 

          PART Ph 2406  IMMUNITY

                  Section Ph 2406.01  Immunity

 

CHAPTER Ph 2500  AUTOMATED PHARMACY SYSTEMS

          PART Ph 2501  PURPOSE AND SCOPE

                  Section Ph 2501.01  Purpose

                  Section Ph 2501.02  Scope

 

          PART Ph 2502  DEFINITIONS

                  Section Ph 2502.01  Definitions

 

          PART Ph 2503  REGISTRATION

                  Section Ph 2503.01  Application

 

          PART Ph 2504  AUTOMATED PHARMACY SYSTEMS IN COMMUNITY SETTINGS

                  Section Ph 2504.01  Location, Access, and Other System Requirements

 

          PART Ph 2505  AUTOMATED PHARMACY SYSTEMS IN REMOTE SITES

                  Section Ph 2505.01  Requirements for the Automated Systems in Remote Sites

 

          PART Ph 2506  AUTOMATED PHARMACY SYSTEMS FOR EMERGENCY KIT USE

                  Section Ph 2601.01  Definitions

                  Section Ph 2601.02  Automated Pharmacy Systems Emergency Kit Use Requirements

 

          PART Ph 2507  AUTOMATED PHARMACY SYSTEMS FOR HOSPITAL SETTINGS

                  Section Ph 2507.01  Automated Pharmacy Systems for Hospital Setting Requirement

 

CHAPTER Ph 2600  PHARMACIST INITIATION AND DISPENSING OF NICOTINE CESSAGION THERAPY

          PART Ph 2601  PURPOSE, SCOPE, AND COOPERATION

                  Section Ph 2601.01  Purpose

                  Section Ph 2601.02  Scope

                  Section Ph 2601.03  Cooperation

 

          PART Ph 2602  DEFINITIONS

                  Section Ph 2602.01  Definitions

 

          PART Ph 2603  PHARMACIST REQUIREMENTS FOR CERTIFICATION

                  Section Ph 2603.01  Pharmacist Requirements

 

          PART Ph 2604.01  PHARMACIST RECORDKEEPING PROCEDURES

                  Section Ph 2604.01  Recordkeeping Procedures

 

          PART Ph 2605  STANDARDS OF PRACTICE

                  Section Ph 2605.01  Pharmacist Standards of Practice

                  Section Ph 2605.02  Prohibited Practices and Restrictions

 

          PART Ph 2606  IMMUNITY

                  Section Ph 2606.01  Immunity