LUNCH AND LEARN USP Chapter <797>: What s on the Radar? October 14, 2016 Featured Speaker: Patricia C. Kienle, RPh, MPA, FASHP Director, Accreditation and Medication Safety Cardinal Health Innovative Delivery Solutions CE Activity Information & Accreditation (Pharmacist and Tech CE) 1.0 contact hour Funding: This activity is self funded through PharMEDium. It is the policy of to ensure balance, independence, objectivity and scientific rigor in all of its continuing education activities. Faculty must disclose to participants the existence of any significant financial interest or any other relationship with the manufacturer of any commercial product(s) discussed in an educational presentation. Ms. Kienle is an employee and stockholder of Cardinal Health, and is a USP volunteer of the Compounding Expert Committee. 2 www.proce.com 1
Online Evaluation, Self-Assessment and CE Credit Submission of an online self assessment and evaluation is the only way to obtain CE credit for this webinar Go to www.proce.com/pharmediumrx Print your CE Statement online Live CE Deadline: November 11, 2016 CPE Monitor CE information automatically uploaded to NABP/CPE Monitor upon completion of the self assessment and evaluation (user must complete the claim credit step) Attendance Code Code will be provided at the end of today s activity Attendance Code not needed for On Demand 3 Ask a Question Submit your questions to your site manager. Questions will be answered at the end of the presentation. Your question...? 4 www.proce.com 2
Resources Visit www.proce.com/pharmediumrx to access: Handouts Activity information Upcoming live webinar dates Links to receive CE credit 5 USP Chapter <797>: What s on the Radar? Patricia C. Kienle, RPh, MPA, FASHP Director, Accreditation and Medication Safety Cardinal Health Innovative Delivery Solutions 6 www.proce.com 3
Objectives Differentiate the primary focus of risk levels in current and proposed revised USP Chapter <797> Identify the primary oversight agency for compounding pharmacies and for outsourcing facilities Define in use time State the beyond-use-times for biologics in the FDA draft guidance on Mixing, Diluting, or Repackaging Biological Products State the geographic limit that a health-system s centralized compounding pharmacy can distribute to based on the FDA draft guidance on Hospital and Health-System Compounding 7 USP Chapter <797> Pharmaceutical Compounding Sterile Preparations 2004 2008 2015??? 8 www.proce.com 4
Drug Quality and Security Act Split the compounding section in the Food, Drug, and Cosmetic Act into two sections 503 A Traditional pharmacies, which mix patient-specific compounded sterile preparations (CSPs) 503 B Outsourcing facilities, which mix nonpatient-specific compounded sterile preparations 9 Oversight of Compounders Entity Description Oversight 503 A Pharmacy State Board of Pharmacy 503 B Outsourcing facility FDA 10 www.proce.com 5
Both Types of Entities Make CSPs So What s the Difference? Prescriber Pharmacist 11 Both Types of Entities Make CSPs So What s the Difference? Patient Prescriber Pharmacist 12 www.proce.com 6
Non-Patient-Specific CSPs Often called office use Differs from anticipatory compounding FDA only allows office use mixtures to be made by a 503 B entity 13 Proposed Revised Chapter <797> Published for public comment in September 2015 Comments still being reviewed Expect a new proposed revision Several significant changes in the proposal 14 www.proce.com 7
Major Changes in Proposed Revised Chapter <797> Change from risk levels and beyond-use dates (BUDs) based on ingredients used to based on facility in which mixed Removal of information about hazardous drugs Refer to USP Chapter <800> Hazardous Drugs Handling in Healthcare Facilities Addition of information on in use time Frequency of monitoring 15 Current Chapter <797> BUDs Based on type of ingredients All sterile components Low risk if for one patient Medium risk if for multiple patients, multiple occasions, or more complex mixtures Some non-sterile components High risk Based on temperature at which stored 16 www.proce.com 8
Current Chapter <797> BUDs Risk Level Storage Temperature BUD 17 Proposed Revised Chapter <797> BUD based on facility in which CSP is mixed Cleanroom suite ISO 7 or 8 anteroom + ISO 7 buffer room Primary Engineering Control Segregated Compounding Area No requirement for ISO classification Primary Engineering Control 18 www.proce.com 9
Drugs vs. Biologics Biological product A virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein or analogous product or arsphenamine or derivative Applicable to the prevention, treatment, or cure of a disease or condition of human beings Highly susceptible to microbial contamination 19 FDA Draft Guidance on Biologics Propose very short beyond-use dates (BUDs) BUD if mixed, diluted, or repackaged by a 503A pharmacy Not longer than 4 hours, or Up to 24 hours if microbial challenge studies performed BUD if mixed or diluted by a 503B outsourcing facility Not longer than 4 hours, or Up to 24 hours if microbial challenge studies performed 20 www.proce.com 10
FDA Draft Guidance on Biologics BUD if repackaged by a 503B outsourcing facility Not longer than 4 hours, or Up to 24 hours if microbial challenge studies performed, or Up to 5 days if compatibility studies are performed on the container and closure to demonstrate compatibility and product integrity 21 Hazardous Drug Compounding USP Chapter <800> was published on February 1, 2016 and becomes federally enforceable on July 1, 2018 Based on drugs defined as hazardous by NIOSH Carcinogens Tetratogens Genotoxins Reproductive or developmental toxins Organ toxicity at low doses in humans or animals 22 www.proce.com 11
Major Sections of USP Chapter <800> Hazardous Drug (HD) list Employee acknowledgement of handling HDs Assessment of Risk Entity may exempt some HDs that are not antineoplastic from some of the requirements in Chapter <800> as long as alternative containment strategies are identified and used Facilities Separate room, negative pressure, vented to the outside, with an appropriate number of air changes per hour 23 Closed System Drug-Transfer Devices (CSTDs) CSTDs mechanically prohibit the transfer of environmental contaminants into the system and the escape of HD or vapor concentrations outside the system Chapter <800> recommends use during compounding and requires use for administration of antineoplastics Photo courtesy of BD 24 www.proce.com 12
In Use Time Current Chapter <797> Any manipulation = compounding Proposed revised Chapter <797> Exempts administration In Use time Expiry of single dose containers Expiry of multiple-dose vials Hang time once administration starts 25 Frequency of Monitoring Environmental monitoring Non-viable (particle) monitoring Viable (microbial) monitoring Surface sampling Personnel monitoring Media-fill test Gloved fingertip test 26 www.proce.com 13
FDA Draft Guidance Document April 2016 Hospital and Health System Compounding Under the Federal FD&C Act Acknowledges that hospitals are different from community pharmacy compounders Limits use of non-patient-specific CSPs to a one mile distance from where they are compounded Public comment period has ended 27 Hospital Pharmacies Receive FDA 483s FDA issues that mesh with Chapter <797> Extending BUDs beyond the Chapter <797> defaults Hoods certified at rest (not dynamic) conditions Lack of smoke studies to demonstrate proper air flow Improper testing (sterility, endotoxin, fungal) Wearing make-up in the cleanroom 28 www.proce.com 14
Hospital Pharmacies Receive FDA 483s FDA issues that do not mesh with Chapter <797> Use of sterile garb Expectation of recertification of cleanroom when air handling shuts down for a short period of time 29 FDA Draft Guidance Document August 2016 Insanitary Conditions of Compounding Facilities Applies to both 503 A and 503 B entities Major issue: Public health risk 30 www.proce.com 15
Particularly Serious Conditions Vermin Visible microbial contamination Non-microbial contamination in ISO 5 or adjacent areas Performing aseptic manipulation outside of ISO 5 Exposing unprotected sterile product to lower than ISO 5 Unsealed ceiling tiles Production while construction is underway Pressure reversals from less clean to cleaner air Inadequate sterilizing filter Inadequate heat sterilization 31 Current and Expected Trends Hospital pharmacies depend on 503 B entities to provide CSPs that they don t have the capacity to compound Limited facilities Limited personnel Deployment of resources 32 www.proce.com 16
Need for Office Use Compounds Increasing ambulatory procedures and increasing complexity of specialized procedures often requires mixtures that are not commerciallyavailable Acute level of care requires the CSPs without the ability to wait until the specific patient is identified 33 Need for Extended BUDs Short BUDs permitted by Chapter <797> are for protection of the patient Short BUDs are often not practical from a hospital pharmacy perspective 34 www.proce.com 17
Compounded Sterile Preparations 503 A Pharmacy 503 B Outsourcing Facility 35 Q&A 36 www.proce.com 18