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 . 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.

2 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. 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.

3 Compliance and Education .. Disciplinary Authority ..6 Section B: Pharmacist Licensing Requirements .. 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 .. Terminating Business .. Class-B Hospital PHARMACY .. Class-E Radiopharmaceuticals (Nuclear).

4 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 ..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.

5 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 .. 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.

6 Automated Filling Systems .. Epinephrine/Asthma Medication .. Medical Marijuana ..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 ..82 Page 5 Table of ContentsPractice GUIDE Environmental Sampling .. End-Preparation Evaluation .. Remedial Investigations/Recalls.

7 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 ..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.

8 Documentation Renewals/Continuing O: PHARMACY Registration Authorized Activities .. Name, Address & Employment Mandatory Reporting of Technician Disciplined/Disqualified Technician Compliance P: Intern License Requirements .. Supervision/Authorized Activities .. Immunization/Administering Medication .. Intern Site/Preceptor Information ..112 Section Q: Long-Term License Requirements .. Authorized Dispensing .. Preparation/Packaging .. Labeling .. Return, Reuse & Disposal ..114 Page 6 Table of ContentsPractice GUIDE 2020 SECTION A: REGULATORY BOARD AUTHORITY Pursuant to Chapter 338, of the Revised Statutes of MISSOURI , the Board has regulatory authority over the PRACTICE of PHARMACY in MISSOURI which includes, but is not limited to, monitoring compliance, conducting investigations/inspections and licensing pharmacists, intern pharmacists, PHARMACY technicians, pharmacies, drug distributors, drug outsourcers and third-party logistics providers.

9 The Board s administrative rules are promulgated in Chapter 20 CSR 2220 of the MISSOURI Code of State Regulations. The MISSOURI Bureau of Narcotics and Dangerous Drugs ( BNDD ) regulates controlled substance distribution in MISSOURI . However, the Board monitors and inspects compliance with applicable controlled substance drug laws. For controlled substance questions, contact BNDD at (573) 751-6321 or e-mail E-mail is preferred. The MISSOURI Department of Health and Senior Services (DHSS) has regulatory jurisdiction over PHARMACY services provided within the licensed premises of a MISSOURI hospital (see Chapter 197). However, Class-B hospital pharmacies are under the Board s jurisdiction (see ). DHSS related hospital questions should be addressed to (573) 751-6303 or COMPLIANCE AND EDUCATION The Board is committed to promoting voluntary compliance through education and awareness.

10 A variety of free PRACTICE resources are available on the Board s website including:1. Brochures/Compliance Guides: Brochures on a variety of compliance topics are available online at , including, Inspector Tips for Preventing Drug Diversion, the Compliance Top 10, the Pharmacist Immunization/Administration Checklist and the PHARMACY Self-Assessment GUIDE . Resources are also available for technicians such as the Technician Compliance GUIDE and a free online Technician Webinars: The Board periodically hosts free webinars to discuss emerging compliance issues and trends. Pharmacist CE is available for attending live webinars. Recorded webinars are available on the Board s website for on-demand review at # Newsletters/E-Alerts: Sign-up for the Board s newsletter and e-alerts at to receive webinar notices and other regulatory updates, including, notification of technician disciplinary DISCIPLINARY AUTHORITY The Board may impose discipline if a licensee/registrant, or any officer, owner, pharmacist-in-charge or manager-in-charge, has committed any act identified in Grounds for disciplinary action include, but are not limited to: 1.