Missouri Board of Pharmacy Practice Act Review October 5th, 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 Board of Pharmacy Rules/Regulations 13/75 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: Class B: Class C: Class D: Class E: Class F: Class G: Class H: Class I: Class J: Class K: Community/Ambulatory Hospital Outpatient Pharmacy Long Term Care Non-sterile compounding Radiopharmaceutical Renal Dialysis Medical Gas Sterile Product Consultant Shared Service 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 • Apparel – Risk Level 1: No Requirements – Risk Level 2: Low Particulate Clothing covers; Head and Facial Hair covered (Gowns/Mask) • Gloves Maintained – Risk Level 3: Level 2 Requirements + Shoe Covers • Exemption for Positive Pressure Barrier Isolator Box 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 Permitted _______________ Dispense As Written 3.011-Generic Formulary Albuterol Aerosol, Metered; Inhalation AB AB AB BN AB AB Armstrong 0.09mg./INH GenPharm 0.09mg./INH Glaxo Smith Kline (Ventolin) 0.09mg./INH Schering 0.09mg./INH Ivax 0.09mg./INH Pliva 0.09mg./INH 12/02 3.011-Generic Formulary • State of Missouri Negative Formulary Albuterol Aerosol Armstrong 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