Missouri Board of Pharmacy Practice Act Review October 5 th, 2004
State Statutes 338.010: Definition of Practice –DUR; Acts, Services, Operations, Transactions of a pharmacy 338.013: Registration of Technicians 338.050: Expiration Dates of Licenses –Pharmacist-Pharmacy-Drug Distributor >October 31
338.055: Unprofessional Conduct Drug or Alcohol Impairment Criminal Prosecution - Guilty or Nolo Contendere Fraud, Misrepresentation to Secure License Obtain Fees or Charges by Fraud Incompetency, Misconduct, Gross Negligence or Dishonesty……...
338.055: Unprofessional Conduct Violating or Assisting in Violations of Chapter 338 and Rules Impersonation Disciplining Actions from other Agencies or States Incapacitation Failure to Maintain Current License Personal Use of C.S. Unless Prescribed, Dispensed or Administered by Qualified Health Provider…..
338.055: Unprofessional Conduct Mistake of Fact - Issuance of License Failure to Display Valid License Violation of Professional Trust or Confidence False or Misleading Advertising Violation of Drug Laws (F/S) Violation of Drug Substitution Law
338.056/057: Generic Substitution Law Name of Manufacturer on Rx or Label Two line Blank Actual Name of Drug on Label Procedure for Oral Rx: Document Prescriber Approval
State Statutes 338.059: Rx/Wholesale Labeling 338.060: Pharmacist License (Renewal) –Exemptions for Military Service –Lapsed License –CE Requirements
338.100: Rx Records Total Retention Time: 5 Years –3 Years Hard Copy –2 Years Microfiche or EDP* Authority to Inspect Copies Court Proceedings
State Statutes 338.110: Board of Pharmacy; Description 338.140: Board Authority 338.150: Inspection Authority 338.155: Immunity 338.180/185/190/195: Access to Criminal Records; Prosecution Authority; Conviction Level (Licensed vs. Unlicensed)
State Statutes 338.196: Rx Originating from Out-of-State 338.210: Definition of a Pharmacy 338.220/240/250: Permit Requirements and Classes. Consignment Arrangement 338.260: Business Name-->Supervised by R.Ph. 338.300: No Transfer of Permits
State Statutes 338.315: Receipt of Drugs 338.330: Definition of Drug Distributors 338.333: Licensing –Temporary vs. Permanent –Exemption for Consignment Delivery 338.337: Out-of-State Distributors 338.340: No Distribution w/o License
State Statutes 338.365: Injunctive Authority 338.370: Penalty Provisions
2.010-Operational Standards Supervision No Pharmacist on Duty Facility Requirements Warehouses Owner Responsibility Rx Files (Manual vs. EDP); Refills; Three File System…….
2.010-Operational Standards Drug/Device Transfer Record Requirements Drug Inventories Drug Samples
2.015-Termination of Business as a Pharmacy Written Notice to the Board----> 15 Days Date of Closing Disposition of the Inventory and Records (Retrievable within 7 Working Days) Termination Date--->Inventory of Controlled Substances (copies with each licensee)…….
2.015-Termination of Business as a Pharmacy No transfer of Misbranded or Adulterated Drugs Return of License (Permit) to the Board
2.018-Prescription Requirements Conformance with Two-line Blank or Originate form Out of State Date, Assigned Unique Readily Retrievable Identifier** Patient(s) Prescriber Prescriber Indication of Drug Name, Dosage, Directions for Use, Actual Name and Dosage…….
2.018-Prescription Requirements Refills Quantity Dispensed and Pharmacist Initials Alterations to a Rx. Based on Prescriber Contact Controlled Substance Information as Required by Law Required on All Rx.---->Handwritten; Telephone; Oral; Fax; Electronic
2.020-Pharmacy Permits Change of Ownership –Business is Sold* –Changes to or Within a Partnership* –Death of an Owner (One year Provision) –Corporate Ownership* –Stock Transfers* *30 Day Grace Period Change of Location(Application/Inspection) vs. Remodeling
2.020 - Pharmacy Permits Permit Classifications –Class A: Community/Ambulatory –Class B: Hospital Outpatient Pharmacy –Class C: Long Term Care –Class D: Non-sterile compounding –Class E: Radiopharmaceutical –Class F: Renal Dialysis –Class G: Medical Gas –Class H: Sterile Product –Class I: Consultant –Class J: Shared Service –Class K: Internet
2.050-Public Complaint Handling Written Complaints Log Book Communication with Complainant Records Release/Confidentiality
2.080-E.D.P. (1)Original Rx. vs. Refill Documentation (2) System Capability Requirements (3) Rx Records Available During Inspection (4) Proof of Refill Information Accuracy (5) Logbook or Separate Signature File (7) On-Line Record Retrieval During Inspection
2.080-E.D.P. (8) Auxiliary Record System Maintained (9) Prescription Transfers-Deactivation (10) Purge Requirements---Record Production---> 3 Business Days (13) Drug Utilization Review Requirements
2.085-Electronic Transmission of Prescription Data Includes both Image and/or Data Transmission with Validation Requirements Generation of Hard Copies - Security Paper Defines Electronic Signature Original facsimile of Rx. Must be Maintained in Files System Must Guard Against and Detect Unauthorized Access Rx. Alterations Must be Documented and Identify Responsible Pharmacist
2.090-Pharmacist-in-Charge Number of Pharmacies is not Restricted Change in Status---->P.I.C. is Responsible Change in P.I.C. Inventory of Controlled Substances…….. Maintain Compliance with Automated Dispensing and Storage System Requirements
2.090-Pharmacist-in-Charge Appropriate and Direct Supervision Maintain Adequate Security “No Pharmacist on Duty” Posted All Licenses Current and Displayed Compliance with Recordkeeping Laws Compliance with Controlled Substance Laws………..
2.090-Pharmacist-in-Charge Compliance with Labeling Laws Compliance with Generic Substitution Laws and Formulary Maintenance of Poison Register Maintenance of Sanitation Maintenance of Equipment Inventory Free of Outdated Drugs…….
2.090-Pharmacist-in-Charge Compliance with Drug Sample Laws Inventory Q/A >Misbranded Drugs >Adulterated Drugs Compliance with Drug Distributor Laws Compliance with Patient Counseling Laws Compliance with P/P for Proper Registration and Supervision of Technicians
2.100 Continuing Education 30 Contact Hours Required - Biennial Renewal ACPE or Board Approved Programs Programs Approved by Other State Boards of Pharmacy Inactive License –No Practice of Pharmacy –Makeup of Hours before Reinstatement to Active Status
2.110-PRN Refills 1 Year Limit from Date Rx. is Written Assurance that All Rx. have Proper Prescriber/Patient Relationship Documentation of Authorizations Must Appear in Records in Uniform Fashion
2.120-Transfer of Prescription Information Controlled Substances: 1 Transfer and Must be Between Two Licensed Pharmacists Pharmacies Sharing E.D.P. Database May Transfer as long as Refills Available Records of Transferred Controlled Substances Must Include Dates and Locations of all Previous Refills…….
2.120-Transfer of Prescription Information Recordkeeping (Transferring Pharmacy) –Indicate transfer; Indicate Pharmacy –Date of Transfer; Transferring Pharmacist –Voiding of Rx. –Controlled Substances--->Address and DEA Number of Pharmacy and Pharmacist Receiving Rx. ……….
2.120-Transfer of Prescription Information Receiving Pharmacy –Rx. Information; Indicate Transfer and the Name of the Original Pharmacy and Transferring Pharmacist –Original Rx. Date; Original Dispensing Date (if different) –Original Number of Refills; Remaining Refills; Date of Last Refill; Original Rx. Number…….
2.120 Transfer of Prescription Information Receiving Pharmacy (cont.) –Controlled Substance Rx.- Address and DEA Number from all Previous Transferring Pharmacies
2.130-Drug Repackaging Pre-Packs Pharmacies that Repackage or Relabel for Outside Distribution to Other Facilities or Practitioners Must: –Register with FDA as Repackager and be Subject to GMP Inspections –Annual Listing of All Drugs Repackaged…..
2.130-Drug Repackaging Standards for Pre-packs –Minimum USP Requirements –Expiration Date: Manufacturers Expiration or 12 Months, Whichever is Less.** –Labeling: Name and Strength of Drug, Name of Manufacturer or Distributor, Expiration Date and Assigned Lot Number –Containers: Class “B” Minimum 37/75
2.140-Long Term Care Policy and Procedure Manual Required –Dispensing Procedures –Notification to Institution of Unavailability of Drug –Labeling –Drug Returns/Destruction Disposition of Controlled Substances –Direction Change Labels: Temporary Labels Used by LTC Staff.
2.140- Long Term Care Definitions: –Long Term Care Facility: Nursing home, retirement care, mental care or other facility or institution which provides extended health care to resident patients. –Remote Dispensing System: Any system of an automated or manual design that is used to provide doses of medication for immediate administration by authorized health care personnel and is not licensed as a pharmacy. >
2.140-Long Term Care –Pharmacist Must Supervise Restocking of System. –Repackaging Requirements –Security - P/P Prescription Drug Order Defined –Exception to Rx Two Line Blank –Separate Rx File is Allowed –Meds. That Leave the Facility
2.145 - Standards for Multi-Med Dispensing (Packaging) Customized Packaging with Proper Consent Solid Oral Dosage Forms Patient Package Insert for Each Drug Packaging Must Meet Board Requirements or Manufacturer if More Stringent Packaging Can Show Evidence of Tampering Child Resistant Packaging Standards Required
Standards for Multi-Med Dispensing (Labeling) Each Container Labeled for Time of Administration Label Must Include: Patient Name; Med Pack Serial Number (Additional to Rx); Name, Strength, Physical Description/ID, Quantity of Each Product; Directions for Use/Caution Statements for Each Product; Storage Requirements; Prescriber for Each Product; …………...
Standards for Multi-Med Dispensing (Labeling) Date of Preparation; Beyond Use Date (No More than 60 Days Beyond Preparation Date); Name/Address/Telephone of the Pharmacy; All Other Required Statements of Manufacturer or USP Each Separate Container Must ID Drug Products Contained Therein
Standards for Multi-Med Dispensing (Files) Maintain Separate Record for Med-Packs. Each Record Contains: –Name and Address of the Patient –Rx. Number for Each Drug Contained Therein –Identity of Manufacturer/Labeler and Lot Number for Each Product –Description of Med-Pack Sufficient to Provide Patient with Duplicate Med-Pack for Future Refills……………….
Standards for Multi-Med Dispensing (Files) –Preparation Date and Beyond Use Date –Special Labeling Instructions –Initials of the Dispensing Pharmacist Custom Packaging Restrictions –No Return and Reuse Allowed –No Custom Packaging of Controlled Substances Allowed
2.190-Patient Counseling Maintain and Review of Patient Information Minimum Requirement--->Offer –Any Pharmacy Employee –Written Offer When Patient or Caregiver Not Available –“Offer” Required on All New and Refill Rx. –Inpatients are Exempt
4CSR 220-2.200 Sterile Pharmaceuticals Definitions> –Batch: Compounding of multiple units within a single discrete process by the same individual(s)…..one limited time period. –Beyond Use Date: Date After Which a Product Should not be Used. Assignment Based on Immediate/Short Term Use. –Emergency Dispensing: High Risk Level Product Needed Prior to Appropriate Testing. Documentation - Need/Prescriber Approval Separate Authorizations Required
4CSR 220-2.200 Sterile Pharmaceuticals –Validation: Documentation that can show consistent Quality Assurance that Processes Used will Produce Products Meeting Predetermined Specifications and Quality. Risk Levels –1: Stored at Room Temperature (48 Hours) Stored under Refrigeration (7 Days) Stored Frozen (30 Days) Unpreserved Product (Administered to 1 patient) Preserved Product (Batch Prepared for > 1 patient) Closed System Aseptic Transfers
4 CSR 220-2.200 Sterile Pharmaceuticals –2: In Addition to Level 1 Requirements: Must Use Closed System Transfer Methods Products Are Stored Beyond Level 1 Requirements or; Batch Prepared Products (w out) Preservatives for More than one patient or; Compounding by Numerous/Complex Manipulations Using a Closed System Transfer Method (Manufactured Container e.g., Automated Compounder)
4CSR 220-2.200 Sterile Pharmaceuticals –3: Use of Non-Sterile Ingredients/Containers or Equipment Before Terminal Sterilization or; Compounding Using an Open System of Transfer Before Terminal Sterilization (Sterile or Non-Sterile Ingredients) Policy and Procedure Manual –Completed for All Risk Levels Provided –Annual Review
4CSR 220-2.200 Sterile Pharmaceuticals Personnel Education and Training –Level 1: Experiential Training –Level 2: Risk Level 1 + Competency via Process Simulation –Level 3: Risk Level 1 and 2 Requirements + Specific Product Preparation Training –Q/A - End Product Testing; Sterilization; Selection of Containers, Equipment and Closures –Specific Training on Aseptic procedures for the Specific Product and Processes.
4CSR 220-2.200 Sterile Pharmaceuticals Facilities –Level 1: Separate Area Class 100 Environment for Critical Area –Disinfected Prior to Each Use –Re-Certified every 6 Months/When Moved; Pre-Filters Changed According to Manufacturer Directions –Pumps Recalibrated According to Manufacturer (Documented) Separate Area for Hot/Cold Water and for Labeling, Order Entry and Recordkeeping
4CSR 220-2.200 Sterile Pharmaceutical Level 2: In Addition to Risk Level 1: –Controlled Area Must Meet Class 10,000 Standards; –Floors Disinfected Daily; Equipment Surfaces Daily and Walls Monthly –Environmental Monitoring of Air and Surfaces –Critical Area Cleaned Between Batches –Automated Compounders: Calibrated and Accuracy Verified According to Manufacturer Requirements
4CSR 220-2.200 Sterile Pharmaceuticals Level 3: In Addition to Risk Level 1 and 2; –Compounding in a Class 100 Workbench Within a Class 10,000 Clean Room –Compounding in a Class 100 Clean Room –Compounding Within a Positive Pressure Barrier Isolator –Walls and Ceilings Disinfected Weekly –Sterilized Equipment Only in Contact with Sterile Products
4CSR 220-2.200 Sterile Pharmaceuticals Product Preparation and Validation –Risk Level 1: Work Environment Ingredients and Closures –Essential Materials Only: Arranged for Proper Air Flow –Disinfect all Surfaces, Equipment and Containers Aseptic Technique/Validation –Scrub –Restrict Extemporaneous Activities –Technique Validation Annually (Additional Validation)
4CSR 220-2.200 Sterile Pharmaceuticals –Risk Level 2: (In addition to Risk Level 1) File for Product Batch Information Verification of Calculations Accuracy of Automated Compounders Validation: Process Simulation
4CSR 220-2.200 Sterile Pharmaceuticals –Risk Level 3: (In Addition to Risk Level 1 & 2) Standards for Non-Sterile Components –Certificate of Analysis Batch Preparation Files to Include Yield vs. Actual Information Sterilization/Quarantine Specifications Final Container Capabilities Ie. Sterility Validation: Written Policies/Procedures on Procedures, Equipment and Techniques
4CSR 220-2.200 Sterile Pharmaceuticals Records –Risk Level 1 Training/Competency Evaluations Temperature Logs Certification of Workbenches Copies of Any Manufacturer Standards Maintenance/Calibration –Risk Level 2 (In Addition to Risk Level 1) Batch Preparation/End Product Testing
4CSR 220-2.200 Sterile Pharmaceuticals –Risk Level 3 ( In Addition to Levels 1 & 2) Preparation Work Sheet Sterilization Records Quarantine records (if applicable) End Product Evaluation/Testing Ingredient Validation Records Records Must Be Maintained for 2 Years Beyond Use Dating –Risk Level 1 & 2: Stability/Sterility Data –Risk Level 3: Same as Risk Level 1 & 2 > 30 Days: Stability/Potency Tests Required and Product Specific/Instrumental Analysis Approved
4CSR 220-2.200 Sterile Pharmaceuticals End Product Evaluation –Risk Level 1 & 2 Require Visual Inspection –Risk Level 3 Requires a Statistically Valid Sampling Plan for: Sterility Testing Parenteral Products - Pyrogenicity Non-Sterile to Sterile Products: Quarantined Pending Tests for Sterility and Pyrogenicity; Potency Confirmation if Stored for > 30 Days Emergency Dispensing of Level 3 Products Exemption
4CSR 220-2.200 Sterile Pharmaceuticals Compare/Contrast with USP Chapter 797 –Defining Risk Levels Type of Materials Used (See Handout) (>) Storage Conditions for Final Products (>) Exposure to Inferior Quality Air (Level 3) (>) –Clean Rooms Physical Characteristics of Construction(>) Environmental Controls (<) Critical Area Requirements (<) Filter Maintenance (<)
4CSR 220-2.200 Sterile Pharmaceuticals –Gowning All Risk Levels (>) –Validation Requirements Specific Media Fill Requirements (>) –Recordkeeping (<) –Cytotoxic Drug Controls (<)
2.300-Record Confidentiality Patient Care Records-->CONFIDENTIAL –Rx., Rx. Orders, Patient Profiles, –Must Maintain Adequate Security –Records Released to: Patient, Prescriber or Current Practitioner, Requests or Subpoenas from a Lawful Court, Person Authorized by Court Order, Patient Authorized Access, Pharmacist/Pharmacist, As Authorized Under HIPPA – Board Rep.: Authority to Inspect and Copy
2.400-Compounding Standards Compounding: Based on Rx. or Research Manufacturing: Extraction or Synthesis; Promotion of Product(s)…… Batch Product Defined* –“Specific quantity…compounded in a single, discrete process….during one limited time…” Beyond Use Date is Defined*
2.400-Compounding Standards Space and Equipment Ingredient and Container Control Q/A Procedures –Safety and Effectiveness –Recordkeeping: Separate Log*--->Methods to insure quality and purity; date; R.Ph.; Ingredients; Process; Source/Lot #; Identifier –Product Inventory Must be Reflective of Rx. History--->3 Months of Inventory External Use Products--->1 Year…...
2.400-Compounding Standards Q/A (cont.) –Records Must be Maintained--->2 Years –Actual Name of Each Therapeutic Ingredient on Label to Consumer* –Illness or Lesions Must be Excluded from Contact with Product or Equipment –No Solicitation of Business for Specific Products
2.400 - Compounding Standards Management of Compounding* –Pharmacist Responsibility (Identity; Quality; Purity) Assure that Processes Are Completed –Drugs Must Meet Compendial Standards-C/A –Drug Monitoring Systems Infection Rates Adverse Drug Reactions Incidence of Recalls Complaints from Patients and Prescribers –Recall Standards (Physicians/Patients/Board)
2.400 - Compounding Standards Compounding of Commercial Products is Prohibited* –Products Withdrawn or are Unavailable –Clinical Necessity Modification of OTC Products is By Rx. Only* Authority to Compound a Drug: By Patient Specific Rx. Only
2.600-Standards for Class F Renal Dialysis Pharmacy Limited to Dispensing Pre-packaged Drugs to Patients at Residence or Dialysis Clinic and Directly Related to Dialysis. P.I.C.-Consultant –Weekly Review of Operations: Appropriate Supervision Only Formulary Drugs Provided Patients Adequately Trained Approve all Drug Related P/P
2.650 Standards for Class J Pharmacy: Shared Services Shared Service: Processing by one pharmacy of a request from another pharmacy. –Dispensing –DUR –Claims Adjudication –Refill Authorizations –Therapeutic Interventions
2.650 - Class J: Shared Service Pharmacies Requirements –Same Ownership or Contract that provides for services provided; Responsibilities of each licensee; Accountability for services provided –Maintain separate licenses at each location involved –Share EDP or Sufficient Information Necessary to Fill or Refill a Rx. That is Real Time/On-line Access.
2.650 - Class J: Shared Service Pharmacy –P/P Manual Methods of Compliance with State and Federal Drug Laws Maintenance of Records that can Identify the Pharmacist Responsible for Dispensing and Counseling Rx. Order Processing Adequate Protections for Confidentiality and Integrity of Patient Records Quality Assurance Program that Monitors for Proper Patient Outcomes
2.700 Pharmacy Technician Registration Registration Completed and Mailed to Board of Pharmacy Upon Employment Registration or Copy of Application On Site Disqualification List: –Barred from Employment –Conditional Employment Persons Assisting in the Practice of Pharmacy
2.800 - Vacuum Tube Systems Ensure Security –Right Drug to the Right Patient –Secure System from Tampering –Multiple or Switchable Systems are Prohibited –No R.Ph. On Duty - System Must not be in Operation No Direct Line of Sight Then Must Use Video and Audio Systems. (12” Wide Video Minimum)
Automated Dispensing and Storage Systems Mechanical Systems Used to Store, Distribute and Account for All Drug Transactions Documentation Requirements: Locations; System Events; P/P on System Operations, Waste and Security Measures Used Pharmacist Supervises Technicians that Restock No Return and Reuse of Drugs
4CSR 220-2.900 Automated Dispensing and Storage Systems Supervision by Pharmacist Electronically Health Facilities –First Dose Release Ambulatory Care Setting –Input of Rx. –Limited to Prescribers at Specific Location –Pharmacist Available at All Times for Counseling
4CSR 220-2.900 Automated Dispensing and Storage Systems –Labeling in Compliance with 338.059 Label Application: Prior to Release – Records of Transactions Must be Maintained Separate for Each Remote Site –Perpetual Inventory of Controlled Substances –Location: Private and within Same Area Used for Clinical Services –Required Audio and Video Systems 65/75
4CSR 220-2.900 Automated Dispensing and Storage Systems All Automated Systems –Tests of the System: 6 months or with any Upgrade –Loading of Machines Each Remote Licensed as Class J: Shared Service Supervisor Pharmacist: Restricted to 3 Sites Simultaneously/Exceptions
3.011-Generic Formulary For___________________Date_______ Address___________________________ Rx ______________ _______________ Substitution PermittedDispense As Written
3.011-Generic Formulary State of Missouri Negative Formulary Albuterol AerosolArmstrong Pharm. GenPharm Glaxo Smith Kline Ivax Sidmak Chlorpromazine HCL; Tablet 12/02
3.040-Return and Reuse of Drugs Accepted from Institutions Only –Hospitals –LTC Facilities –Hospice Facilities Assurance of Storage Requirements –Manufacturer/USP –Pharmacy Originally Dispensed Drug Lot Number and Expiration Date Traceable
3.040 Return and Re-Use of Drugs Returns for Re-use Must: –Original Manufacturer’s Packaging with T-ES –Federal Registered Repackagers with T-ES* –Licensed Pharmacy Products that are Un-used with T-ES* –Licensed Pharmacy Products where Un-used Portion can be separated and Re-used* NO PRODUCTS CAN BE REPACKAGED* AND RE-USED MORE THAN ONE TIME
Drug Distributor: 5.020 and 5.025-Licensing Requirements Licensure: Same as Pharmacy –Initial Applications –Change of Ownership –Change of Location Temporary License Authority---> 1 Year Out-of-State Facilities: Domestic/Foreign
Drug Distributor: 5.030 Definitions and Standards Personnel Facility: Size, Temp., Sanitation, Segregation of Distressed Drugs Security: Facility and Records Drug Storage P/P Manual Required: Drug Handling, Recalls, Stock Rotation, Loss Reports, Disasters…….
Drug Distributor: 5.030 Definitions and Standards Recordkeeping –Source; Identity; Quantity; Dates of Receipt and Distribution –Records Maintained---> 3 Years –Account for all Outdated, Damaged, Misbranded or Adulterated Articles Exemption from Licensure---5% Total Gross Sales of the Pharmacy (Rx)
Medical Gas Distributor - 5.070 Defined: Compressed/Liquid - Labeled for Medical Use Exemptions: Temperature/Humidity; Floor Pallets; Separate Inventory for Vet. Use; Water Supply; Outdated Drugs; Refrigeration; Exterior Lighting*; Alarm Systems*; Secure Storage Area* Federal Registration: Transfilling *Nitrous Oxide
6.030-Drug and Medical Information Transfers Between Pharmacists or from Pharmacists to Other Health Care Practitioners is Now “Recognized.” –Initial Rx. Transfers (Recordkeeping) –Verbal Orders from Prescribers Noted by Pharmacists in Patient Records