MISSOURI PHARMACY PRACTICE GUIDE

1 MISSOURI Board of PHARMACY PHARMACYPRACTICE GUIDE2020 Page 2 Table of ContentsPractice GUIDE 2020 MESSAGE FROM THE BOARDThe MISSOURI Board of PHARMACY is pleased to provide the MISSOURI PHARMACY PRACTICE GUIDE . The PHARMACY PRACTICE GUIDE is designed to increase licensee compliance by providing guidance on basic provisions of MISSOURI s law governing PHARMACY PRACTICE . The Board has served MISSOURI citizens through the regulation and licensing of the PHARMACY profession since 1909. The Board is an autonomous Board within the Division of Professional Registration, an agency of the MISSOURI Department of Commerce and Insurance. The Board s mission is to serve and protect the public in the PRACTICE of PHARMACY by providing an accessible, responsible and accountable regulatory system that: Protects the public; Licenses only qualified professionals; and Enforces PRACTICE standards.

2 The Board consists of seven (7) members, including, one (1) public member and six (6) licensed pharmacists actively engaged in the PRACTICE of PHARMACY in PHARMACY resources and compliance materials are available on the Board s website at The Board also provides license and regulatory updates via e-alerts and the Board s electronic newsletter. Interested parties can sign up for the Board s newsletter and e-alerts at The MISSOURI PHARMACY PRACTICE GUIDE is provided for informational purposes only and does not constitute a rule statement of general applicability or binding law. Additionally, the PRACTICE GUIDE does not constitute a comprehensive review of all governing law or controlled substance requirements.

3 To ensure compliance, licensees should independently review Chapter 338, RSMo, 20 CSR 2220 and all applicable state and federal laws. Statutes/rules may have changed since this document was issued. In the event of a conflict or inconsistency, duly promulgated or enacted state or federal law shall control. The Board expressly reserves the right to revise the contents as deemed appropriate or necessary. Questions regarding this document can be e-mailed to FROM THE BOARDPage 3 Table of ContentsPractice GUIDE 2020 TABLE OF CONTENTSS ection A: Regulatory Information General Authority .. Compliance and Education .. Disciplinary Authority ..6 Section B: Pharmacist Licensing Requirements.

4 Name, Address & Employment Changes .. Renewals/Continuing Education .. Inactive Licenses .. Jury Duty .. Military Licenses .. Reporting of Disciplinary/Adverse Actions ..11 Section C: Pharmacist Scope of Authorized Activities .. Supervising PHARMACY Staff .. Prescriptive Non-Dispensing Activities Outside of a PHARMACY .. Tele- PHARMACY .. Consulting Activities/Class-I Pharmacies .. Patient Medical Testing .. Nicotine Replacement Therapy Products .. Naloxone Dispensing ..15 Section D: PHARMACY PHARMACY PHARMACY Classes .. License Requirements .. Non-Resident Pharmacies .. Pharmacist-In-Charge .. Change of Change of Location/Remodeling.

5 Terminating Business .. Class-B Hospital PHARMACY .. Class-E Radiopharmaceuticals (Nuclear) .. Class-J Shared Services .. Class-L Veterinary PHARMACY .. Class-M Specialty (Bleeding Disorder) ..33 Section E: PHARMACY Standards of General Requirements .. Facilities .. License Posting .. Required Equipment/References .. Drug Storage Areas/Refrigeration .. PHARMACY Supervision .. Staffing .. Security .. Vacuum Tube Delivery Systems .. Authorized Medication Sources .. Drug Samples .. Offsite Storage Sites .. Policies & Procedures .. Board Reporting/Notifications .. Reporting of Discipline/Adverse Actions.

6 44 Page 4 Table of ContentsPractice GUIDE 2020 Section F: Prescription Dispensing Authority .. Authorized Prescription Forms .. Prescription Requirements ..46F. 5 Prescription Changes .. Patient-Practitioner Relationship .. Authorized Signatures .. Prescription Limits .. Verbal/Telephone Prescriptions .. Faxed/Scanned Prescriptions .. Electronic Prescriptions .. Prescription Transfers .. Telehealth/Telemedicine ..53 Section G: Mid-Level Authorized MISSOURI Mid-Level Prescribers .. Prescription Requirements .. Refills/Quantity Limits .. Non-Resident Mid-Level Practitioners ..58 Section H: Medication General Requirements.

7 Final Product Verification .. Labeling .. Patient Counseling .. Patient Profiles .. Required Patient Identification .. Generic Substitution .. Interchangeable Biological Products .. Drug Utilization Review .. Flavoring .. Syringes & OTC Medication .. Consolidation of Refills .. Emergency Dispensing .. Prescription Delivery Sites .. Early Fills/Refills .. Office Stock Dispensing .. Tablet Splitting .. Prepackaging .. Patient Med Paks .. Child Resistant Containers .. Return To Stock .. Drug Take-Backs .. Distribution vs. Dispensing .. Automated Filling Systems .. Epinephrine/Asthma Medication .. Medical Marijuana.

8 72 Section I: Compounding (Sterile & Non-Sterile) General Requirements .. Prescription Requirements/Compounding for Office Use .. Anticipatory Compounding .. Commercially Available Products .. Product Verification .. Labeling .. Beyond-Use Dates .. Ingredients/Containers .. Facilities/Equipment .. Compounding Log .. Quality Control .. Recalls .. Advertising/Solicitation ..77 Section J: Sterile Compounding General Requirements .. Compounding Definition .. Compounding Risk Levels .. Compounding In Controlled Areas .. Garbing Requirements .. Training Requirements & Media Fill Testing .. Cleaning & Disinfection.

9 82 Page 5 Table of ContentsPractice GUIDE Environmental Sampling .. End-Preparation Evaluation .. Remedial Investigations/Recalls .. Policies & Procedures ..85 Section K: PHARMACY General Requirements .. Non-Electric (Manual) System .. Electrical Data Processing (EDP) System .. Prescription Hard Copies .. Electronic Record Keeping (ERS) System .. Confidentiality .. Record Retention ..90 Section L: Administration by Medical Prescription Authorized Activity .. Prescription Requirements .. Drug Store .. Patient Evaluation .. Policies & Procedures .. Records .. Reporting/Notifications .. ShowMeVax Reporting.

10 93 Section M: Immunization by General Requirements .. Immunization Qualifications .. Protocol Requirements .. Authorized Sites .. Patient Evaluation .. Prescription Requirements .. Notifications .. Records .. ShowMeVax Reporting ..98 Section N: Medication Therapy General Certification Scope of Authority .. Protocol Requirements .. PHARMACY Prescription Therapy Modifications .. Documentation Renewals/Continuing O: PHARMACY Registration Authorized Activities .. Name, Address & Employment Mandatory Reporting of Technician Disciplined/Disqualified Technician Compliance P: Intern License Requirements.