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2/27/2020Board Rulemaking MAR 72Final Rule MAR Notice No. 24-174-72Effective December 7, 2019 Administration of Vaccines by Pharmacists––––– Aligns with legislative changes to 37-7-105, MCA, pursuant to HB 231Age 7 and older per CDC guidelines and collaborative practice agreementUpdated information about patient, product, pharmacist, and pharmacy to be maintained inpatient recordRemoved language duplicative to statuteARM 24.174.503MPDR Fee––––Aligns with legislative changes to 37-7-1511, MCA, pursuant to SB 61All licensees authorized under Title 37, MCA, to prescribe or dispense prescription drugs arerequired to pay the MPDR feeFee continues to be collected at time of license renewalARM 24.174.1712Board Rulemaking MAR 73New Rule MAR Notice No. 24-174-73Effective January 18, 2020 Positive Identification for Controlled Substance Prescriptions–Implements provisions of 37-7-410, MCA, pursuant to HB 86–Requires positive identification of recipient of controlled substance prescription,with exceptions, and documentation–Authorized identification in statute: Valid driver’s license; a school district/postsecondary photo ID; tribal photo ID–Authorized identification in rule: Valid government-issued photo ID, including but not limited to passport, military, orstate-issued ID–Current reference: ARM 24.174.842 as identified in MAR Notice No. 24-174-73 Effective but not yet updated in rules listed online12

2/27/2020Future TopicsNext Proposed Rule Continuing education programs: remove Board from pre-approval of non-ACPEprograms; revise requirements and audit information Prescription transfer: add reference to quantity remaining Device license type: new non-pharmacy license for device/DME/medical gas supplierto separate from other facilities; allow for person-in-charge Drug kits: combine contingency/emergency drug kits into one ruleFuture Rule Topics Wholesale drug distributors, third-party logistics providers, repackagers, andmanufacturers Facility general requirements Facility endorsements for compounding, outsourcing facility, and others Compounding information and references Collaborative practice, inspections, documentation/record keeping, limited servicepharmacy, and othersCurrent Subcommittee Rule Discussions Automated Dispensing Systems/Machines TechniciansQuestionWhat are the 2019 legislative topics related to the MontanaPrescription Drug Registry (MPDR)?A. FundingB. Integration into electronic workflow systems in medical andpharmacy practicesC. Mandatory registrationD. Mandatory use by prescribers of opioids or benzodiazepineseffective July 2021E. All of the above13

2/27/2020QuestionWhat are the 2019 legislative topics related to the MontanaPrescription Drug Registry (MPDR)?A. FundingB. Integration into electronic workflow systems in medical andpharmacy practicesC. Mandatory registrationD. Mandatory use by prescribers of opioids or benzodiazepineseffective July 2021E. All of the aboveTHANK YOU14

2/27/20202019 USP Sterile CompoundingChapter 797 OverviewJOHN DOUGLAS, RPhBOARD INSPECTORMONTANA BOARD OF PHARMACYCertification in Sterile Compounding for Inspectors (CISCI)March 1, 2020Recent Drug Developments and Law Update 2020University of Montana Skaggs School of PharmacyUnited StatesPharmacopeia(USP) General Chapter 795 Pharmaceutical Compounding—Nonsterile Preparations General Chapter 797 PharmaceuticalCompounding – Sterile Preparations General Chapter 800 HazardousDrugs—Handling in Healthcare Settings General Chapter 825 Radiopharmaceuticals— Preparation,Compounding, Dispensing, andRepackaging1

2/27/2020Reference: www.usp.org www.usp.org/compounding/general-chapter-797USP TimelineGeneralChapter 797 PharmaceuticalCompounding2019 Revisions Public comment period July 27, 2018through November 30, 2018 Open microphone session September 5,2018 Intended publication date June 1, 2019 Intended official date of December 1,20192

2/27/2020Important USP Updates: June 1, 2019 – Publication date of revised Chapter 797 (last revised 2008) September 23, 2019 – Revised Chapter 797 postponed until further noticePer USP: “The currently official version of General Chapter 797 (last revised2008) remains official until further hapter-7972019 USP 797 Overview:Sections1. Introduction and Scope2. Personnel Qualifications—Training,Evaluation, and Requalification3. Personal Hygiene and Garbing4. Facilities and Engineering Controls5. Microbiological Air and Surface Monitoring6. Cleaning and Disinfecting CompoundingAreas7. Equipment, Supplies, and Components8. Sterilization and Depyrogenation3

2/27/20209.2019 USP 797 Overview:Sections10.11.12.13.14.15.16.17.18.USP 797 Section 1.Introductionand ScopeSOPs and Master Formulation and CompoundingRecordsRelease TestingLabelingEstablishing Beyond-Use DatesUse of Conventionally Manufactured ProductsUse of CSPs As ComponentsQuality Assurance and Quality ControlCSP Storage, Handling, Packaging, Shipping, AndTransportDocumentationCompounding Allergenic ExtractsThis chapter describes the minimumstandards to be followed when preparingcompounded sterile human and animaldrugs based on current scientificinformation and best practices for sterilecompounding.4

2/27/2020Sterile Compounding is the process of combining,admixing, diluting, pooling, reconstituting,repackaging, or otherwise altering a drug or bulk drugsubstance to create a sterile medication.USP 797 Section 1.Introductionand ScopePreparing a conventionally manufactured sterileproduct in accordance with the directions containedin approved labeling provided by the product’smanufacturer is not compounding as long as theproduct is prepared for an individual patient andfollows the provisions for administration.Administration means the direct and immediateapplication of a conventionally manufactured productor CSP to a patient. It is out of the scope of this chapter Reconstitution: The process of adding a diluent to a solidconventionally manufactured product to prepare a sterilesolution or suspension.USP 797 Section 1.Introductionand Scope Repackaging: The act of removing a sterile product orpreparation from its original primary container and placing itinto another primary container, usually of smaller sizewithout further manipulation. Proprietary bag and vial systems (e.g., ADD-Vantage, MiniBag plus, addEASE):– Docking and activation in accordance with themanufacturer’s instructions for immediateadministration to an individual patient is notconsidered compounding.Docking for future activation and administration isconsidered compounding.5

2/27/2020Category is based on the conditions under which CSPs aremade, the probability for microbial growth, and the time periodwithin which they must be used.USP 797 Section 1.Introductionand ScopeCategory 1: All PECs may be placed in an unclassified segregatedcompounding area (SCA) Beyond use date (BUD):– Controlled room temperature: 12 hours– Refrigerated: 24 hoursCategory 2: PECs (LAFS and RABS) must be placed in an ISO 7 positivepressure buffer room with an ISO 8 positive pressure anteroom. BUD:– Controlled room temperature: 12 hours– Refrigerated 24 hoursPersonnel Qualifications:USP 797 Section 2.PersonnelQualificationsTraining,Evaluation, andRequalification Visual observation of hand hygiene and garbing: every 6months Gloved fingertip and thumb sampling: every 6 months,after media fill test Media fill testing: every 6 monthsCore Competencies 12 months (written and hands-onproficiency): Cleaning and disinfection Calculations, measuring, and mixing Aseptic technique Achieving and/or maintaining sterility and apyrogenicity Use of equipment Documentation of the compounding process (e.g.,master formulation and compounding records) Principles of HEPA-filtered unidirectional airflow withinthe ISO Class 5 area Proper use of PECs Principles of movement of materials and personnelwithin the compounding area6

2/27/2020Gloved fingertip and thumb sampling:USP 797 Section 2.PersonnelQualificationsTraining,Evaluation, andRequalificationDirect touch contamination is the most likely source ofmicroorganisms. Initial gloved fingertip and thumb sampling – before beingallowed to compound.– Evaluates a compounder’s competency in correctlyperforming hand hygiene and garbing.– No fewer than 3 separate times.– Must be performed on donned sterile gloves in the ISO 7buffer room or SCA.– Action level 1cfu (colony forming units) on both hands. Then every 6 months after completing the media-fill test.– Must be performed on donned sterile gloves inside of anISO 5 PEC.– Action level 3 cfu (colony forming units) on both hands.Before entering a compounding area, at aminimum, individuals must: Remove personal outer garments.USP 797 Section 3.PersonalHygiene andGarbing Remove all cosmetics. Remove all hand, wrist, and other exposedjewelry including piercings that could interferewith the effectiveness of garbing. Not wear ear buds or headphones. Not bring electronic devices that are notnecessary for compounding or other requiredtasks into the compounding area. Keep nails clean and neatly trimmed to minimizeparticle shedding and avoid glove punctures.Nail polish, artificial nails, and extenders mustnot be worn.7

2/27/2020Hand Hygiene:USP 797 Section 3.PersonalHygiene andGarbing Must be performed before entering acompounding area Alcohol hand sanitizers alone are notsufficient Brushes must not be used for hand hygiene(potential skin irritation) Hand driers must not be used (airturbulence and contamination) Perform after donning shoe covers, headand facial hair covers, and a face mask. The order of garbing must be determined bythe facility After hands are washed and dried, donremaining garb except sterile gloves, andthen perform hand antisepsis using analcohol-based hand rub with persistentantimicrobial activity immediately beforedonning sterile gloves.To enter a buffer room or SCA must be properlygarbed.USP 797 Section 3.PersonalHygiene andGarbingGarbing Requirements: Gown (non-cotton, low-lint, sleeves thatsnugly fit, enclosed at the neck) Disposable covers for shoes (low-lint) Disposable covers for head and facial hair(low-lint) Face mask Sterile gloves (powder free) If using RABS (CAI or CACI) disposablegloves (either nonsterile or sterile) inside ofgauntlet gloves, and sterile gloves overgauntlet gloves.8

2/27/2020Cleanroom Suite:USP 797 Section 4.Facilities andEngineeringControls All surfaces must be smooth, non-shedding,resistant to damage. HEPA filters must be located in the ceiling of thebuffer and ante-rooms. Returns must be low on the wall. Pressure –differential monitoring systems mustcontinuously monitor the pressure differentials. Aminimum differential positive pressure of 0.02-inchwater column is required between each ISOclassified area. Line of demarcation in the ante-room. No tacky surfaces. Access doors should be hands-free. Sink may be placed inside or outside of ante-room. Buffer room must not contain water sources. Microbiological incubator (if used) must be placedoutside of the classified areas. Temperature of 20 (68 F) or cooler and a relativehumidity below 60%.SCA:USP 797 Section 4.Facilities andEngineeringControls All surfaces must be smooth, non-shedding,resistant to damage. Must be located away from:– Unsealed windows, doors that connect tothe outdoors, and traffic flow.– Environmental control challenges(restrooms, warehouses, cafeterias, etc.) A visible perimeter must establish theboundaries. Sink at least 1 meter from the PEC, outside ofthe perimeter.9

2/27/2020PECs:USP 797 Section 4.Facilities andEngineeringControls Placement must allow for cleaning around allPECs. Smoke pattern test (under dynamic operatingconditions) must be performed initially and every6 months. LAFS (Laminar Airflow Systems) -must be locatedout of traffic patters and away from room aircurrents that could disrupt airflow patter insidethe PEC. RABS (Restricted – Access Barrier System) (CAIand CACI) – the recovery time after opening toachieve ISO 5 air must be documented andfollowed.USP 797 Section 4.Facilities andEngineeringControlsAdded clarifications on Air Exchange RequirementsCompounding AreaUnclassified SCAISO Class 7 room(s)ISO Class 8 room(s)ACPH RequirementNo requirement 30 ACPH (at least 15 from HVAC) 20 ACPH10

2/27/2020Certification: During dynamic operating conditions Required every 6 monthsUSP 797 Section 4.Facilities andEngineeringControlsCertification needs to include: Airflow testing (air velocity/volume, ACPH (fromHVAC/PEC) HEPA filter integrity testing (PEC and SEC) Total particle count testing (all classified areas) Smoke visualization studiesRecertification: When changes to the area such as redesign,construction, or replacement or relocation of any PEC, oralteration in the configuration of the room that couldaffect airflow or air quality.Microbiological Air and Surface Monitoring:USP 797 Section 5.MicrobiologicalAir and SurfaceMonitoring Under dynamic operating conditions Viable air sampling (each classified area):– Initially and Every 6 months Surface sampling (each classified area):– Initially and MonthlyAnd when: New facility and equipment certification After any servicing of facilities or equipment Identified problems/trends11

2/27/2020https://www.usp.org/USP 797 Section 6.Cleaning andDisinfectingCompounding Areas Must be performed by trained andappropriately garbed personnel usingfacility-approved agents and procedures,which must be described in written SOPs. Minimum Contact Time -themanufacturer’s directions or publisheddata for the minimum contact time mustbe followed for the cleaning, disinfecting,and sporicidal agents used. 70 % IPA (Isopropyl Alcohol) must besterile.12

2/27/2020USP 797 Section 6.Cleaning andDisinfectingCompounding AreasUSP 797 Section 6.Cleaning andDisinfectingCompounding AreasTable 8 of the proposed revisedchapter provides the details theminimum frequency for cleaning anddisinfecting surfaces and applysporicidals in classified areas withinthe perimeter of the SCA.Cleaning Supplies(e.g., wipers, sponges, mop heads) Must be low-linting Should be disposable If reusable must be made ofcleanable material and cleanedbefore and after each use. Must be dedicated for use in theclassified areas or SCA, and mustnot be removed except for disposal.13

2/27/2020USP 797 Section 7.Equipment,Supplies, andComponentsUSP 797 Section 7.Equipment,Supplies, andComponentsRestricted-access barrier system (RABS): enclosurethat provides HEPA-filtered ISO Class 5 unidirectionalair that allows for the ingress and/or egress ofmaterials through defined openings that have beendesigned and validated to preclude the transfer ofcontamination, and that generally are not to be openedduring operations. Examples of RABS include CAIs andCACIs.Compounding aseptic containment isolator (CACI): Atype of RABS that uses HEPA filtration to provide anISO Class 5 unidirectional air environment designed forthe compounding of sterile HDs.Compounding aseptic isolator (CAI): A type of RABSthat uses HEPA filtration to provide an ISO Class 5unidirectional air environment designed forcompounding of sterile non-HDs.Components: Any ingredient used in the compounding ofa preparation, including any active ingredient, addedsubstance, and the container–closure system used topackage the preparation. Conventionally manufactured sterile products shouldbe used when available and appropriate for theintended CSP. Facility must establish the identity, strength, purity,and quality of the ingredients obtained. Each lot of commercially available sterile,depyrogenated containers and container–closuresystems must be accompanied by a COA . Any ingredient lacking an expiration date shall not toexceed 1 year after receipt by the compoundingfacility. Date of receipt must be clearly marked. Must be evaluated when received and before use.14

2/27/2020API (Active Pharmaceutical Ingredient):USP 797 Section 7.Equipment,Supplies, andComponents Must be obtained from an FDA-registeredfacility Must comply with USP-NF monograph if oneexists. Must be accompanied by a COA:– Includes the specifications and testresults and shows the API meets thespecifications of the USPNF monograph,if one exists.Sterilization MethodsAseptic Preparation USP 797 Section 8.Sterilization andDepyrogenation Compounding with only sterileingredientsSterilization by filtration (not for asuspension)Terminal Sterilization is preferred, unlessthe CSP or container cannot tolerate (canachieve Sterility Assurance Level of 10-6 ). Dry heat Steam autoclaving (not if moisture,pressure or temp would degrade CSP) Irradiation15

2/27/2020USP 797 Section 9.SOPs and MasterFormulation andCompoundingRecordsFacilities that prepare CSPs, mustdevelop SOPsUSP 797 Section 9.SOPs and MasterFormulation andCompoundingRecordsCompounding Record requiredfor all CSPs Must be reviewed every 12 months Any revisions must be communicated to allpersonnel Master Formulation Record; required if:– CSP prepared in a batch for 1patient– CSPs prepared from nonsterileingredient(s) May be in the form of prescriptionor medication order,compounding log, or label May be stored electronically(must be retrievable)16

2/27/2020Visual Inspection required at thecompletion of compounding andbefore releaseUSP 797 Section 10.Release Testing Check the physical appearance Check that the CSP, its label andthe prescription match Container closure integrity(leakage, cracks, etc.)Sterility Testing (CAT 2 as required)Bacterial Endotoxin TestingUSP 797 Section 10.Release TestingExcludes: Inhalations Topical ophthalmicsRequired for Category 2 CSPs: If made from one or more nonsterileingredient(s) or component(s) AND if assigned a BUD that requiressterility testing17

2/27/2020Label: A display of written, printed, or graphic matter on theimmediate container of any article.Labeling: All labels and other written, printed, or graphic matterthat are 1) on any article or any of its containers or wrappers, or2) accompanying such an article.USP 797 Section 11.LabelingThe label on the immediate container of the CSP must, at aminimum, display prominently and legibly the followinginformation: Assigned internal identification number (e.g., prescription,order, or lot number) Active ingredient(s) and their amounts, activities, orconcentrations Storage conditions if other than controlled room temperature Date prepared BUD Indication that the preparation is compoundedThe label on the immediate container of the CSP mustadditionally display prominently the followinginformation: Route of administration if it is not obvious from thecontainer, or when necessary for the safe use of the CSP.USP 797 Section 11.Labeling Total amount or volume if it is not obvious from thecontainer. If it is a multiple-dose container, a statement stating such. Contact information of the compounding facility if the CSPis to be sent outside of the facility in which it wascompounded. The labeling of the CSP must provide any applicablespecial handling instructions or warning statements.18

2/27/2020USP 797 Section 12.Establis

Board of Pharmacy Members Tony King, Pharmacist, President Starla Blank , Pharmacist, Vice-President Marian Jensen , Public Member, Secretary Courtney Bahny , Certified Pharmacy Technician Mike Bertagnolli , Pharmacist Paul Brand , Pharmacist Charmell Owens , Public Member General Email: dlibsdpha@mt.gov Website: www.pharmacy.mt.gov Phone: 406 .