10/10/2017. Disclosure

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1 Disclosure Ronna Hauser, Vice President, Pharmacy Affairs, NCPA declares no conflicts of interest or financial interest in any product or service mentioned in this program, including grants, employment, gifts, stock holdings, and honoraria. 1

2 Learning Objectives Discuss the implementation timeline for USP 800. Summarize the inspection trends and how to prepare for an inspection. Outline the main protocols and assess budget impact for compliance. The 2018 Readiness Check Up: The Top 5 Things for Compounders to Keep on Your Radar Ronna B. Hauser, PharmD VP, Pharmacy Affairs NCPA 2

3 NCPA Protecting Your Right to Compound NCPA Compounding Committee guides our positions (focused on 503A) NCPA Active participant in FDA Listening Sessions, PCAC Bulk Drug Substance Nominations, DQSA stakeholder coalition NCPA Top Issues of Concern Office use compounding MOU Inspections USP Monograph Issue Essential Copies Creation of bulk positive list PCAC Processes and Makeup NCPA Compounding Committee Members Chair Rich Moon Board Liaison Lea Wolsoncroft Members Donnie Calhoun A.J. Day Cheri Garvin Kelly Selby Elaine Ladd Jake Olson David Rochefort Chris Geronsin Student Ralph Galega 3

4 Top 5 Things for Compounders to Keep on Your Radar 1. FDA Implementation of DQSA/Washington D.C. Activity 2. FDA/State Board of Pharmacy Roles 3. FDA PCAC/Creation of Compounding Lists 4. FDA Inspections Update 5. Important USP Updates/Tips for Success What s in Section 503A Prescription Requirement Anticipatory Compounding Allowable bulk drug products (APIs) positive list Allowable inactive ingredients Negative list Essential copies of commercially available medication Demonstrably difficult list MOU for interstate commerce of distributed compounded products Pharmacy Compounding Advisory Committee (PCAC) 4

5 What s NOT in Section 503A Veterinary Compounding Exemptions provided in 503A only pertain to the manufacture of human drug products (Sections 501(a)(2)(B), 502(f)(1), and 505). FDA s website Information on Compounding : Section 503A describes the conditions under which certain compounded human drug products are entitled to exemptions Human drug compounding/products mentioned many times in guidances. FDA s notice on inspections ( ): (i.e., human drug compounders that are not registered with FDA as outsourcing facilities under section 503B). Thank You! 5

6 Disclosure Cynthia Blankenship, Esq, Executive Vice President International Academy of Compounding Pharmacists declares no conflicts of interest or financial interest in any product or service mentioned in this program, including grants, employment, gifts, stock holdings, and honoraria. 6

7 Regulatory Outlook: FDA Implementation of the DQSA FDA utilizing guidance/policy approach instead of formal rulemaking process but implementing the guidance/policy as FINAL. 20 guidance documents Some examples of guidance/policy: Insanitary Conditions Commercially Available (503A and 503B) 503A Prescription Requirement Hospital and Health System Compounding Repackaging (503A and 503B) Biologics cgmps for 503B Interim/Ongoing Guidance/Policy The Pharmacy Compounding Advisory Committee (PCAC) and the Lists. The DQSA charges FDA and the PCAC with creating three lists: two negative lists and one positive list. PCAC meets about three times per year, considers about six bulk drug products each meeting, but PCAC s vote is NOT binding. Bulk Substances Nominations Categories 1, 2, and 3 Demonstrably Difficult to Compound Withdrawn and Removed (Final Rule/Proposed Rule) Full List: ng/ucm htm 7

8 Regulatory Outlook: FDA Implementation of Office Use Compounding 503A Final Guidance 503A Office-use Compounding; Comments due July 2016; and Finalized on December 28, 2016 Guidance prohibits 503A pharmacies from providing office-use compounding despite State law. While only guidance, FDA is implementing complete prohibition of 503A pharmacies in Warning Letters stating solely based on the fact the pharmacy provides compounded medications to health care facilities for administration to patients, the pharmacy is in violation of the Food Drug and Cosmetic Act. FDA drew a line between anticipatory compounding and office-use. 503A Draft Guidance Hospital and Health System Compounding under the FDCA Released April 15, 2016; Comments due July 18, 2016 Recognizes some hospitals and health systems compound drugs only for use in the hospitals in which the pharmacy is located while other hospitals and health systems distribute to other facilities within their health system (i.e. clinics, infusion centers, long-term care facilities and others purchase compounds from 503Bs. If a hospital or health systems do not meet the three requirements provided in the draft guidance, then it is bound by the general prescription and anticipatory compounding requirements found within 503A 8

9 503A Draft Guidance Hospital and Health System Compounding under the FDCA To qualify for the exemptions under 503A to cgmps, labeling, and drug approval process, FDA states it does not intend to take action if: The drug products are distributed only to healthcare facilities that are owned and controlled by the same entity AND that are located within 1 mile radius of the compounding pharmacy; Only administered within the healthcare facility to patients within the healthcare facility, pursuant to a patient specific prescription or order; and Meet all other provisions of 503A. 503A Draft Guidance Hospital and Health System Compounding under the FDCA If a hospital or health system cannot meet the exemption requirements, then the draft guidance suggests that a hospital or health system may register as a 503B Outsourcing Facility or obtain compounded medications from a 503B Outsourcing Facility. The draft guidance also states that all hospitals and health system compounders that elect to register with FDA as Outsourcing Facilities must comply with all of the provisions of 503B. The draft guidance also states that drugs compounded by Outsourcing Facilities are not exempt from cgmps and will be inspected by FDA on a risk-based schedule. Once a facility registers as 503B, all the facility's compounded drugs must be compounded in accordance with 503B. Those that should not register: if the facility s activities only include repackaging, compounding non-sterile or animal drugs, or mixing, diluting or repackaging biological products subject to licensure under section 351 of the PHS Act. 9

10 Regulatory Outlook: FDA Implementation of the MOU Draft MOU Contents 503A language regarding the MOU State s choice Lower limit/cap set by statute 5% Upper limit/cap determined by FDA 30% Distribution vs. Dispense and FDA s change of definitions Language is distinguished within section 503A of DQSA Language distinguished within the Controlled Substances Act FDA s interpretation and what this means FDA Efforts with State Boards of Pharmacy Appropriate agencies of the State will investigate complaints received relating to human drug products compounded by a pharmacist, pharmacy, or physician located in the State of [insert State] and distributed outside the State. Any investigations performed by the State of [insert State] under this MOU will include, but are not limited to (1) determination of whether there is a potential public health risk or safety concern associated with the compounded human drug product; and (2) confirmation that any risk or safety concern associated with the product is adequately contained (i.e., there is no ongoing risk to the public). 10

11 FDA Efforts with State Boards of Pharmacy State required to take appropriate action. State required to notify FDA via within 72 hours of receiving any complaint related to compounding. State maintains all records and State must review all pharmacy records. How does this work with Section 704 of the FDCA records exemption? Parties must share information. FDA agrees information will not be disclosed. How does this work with FOIA? Regulatory Outlook: FDA Implementation of the PCAC Lists FDA and PCAC Lists Bulk Drug Substances (Positive List) Withdrawn and Removed List (Do Not Compound List) Demonstrably Difficult (Do Not Compound List) 11

12 Pharmacy Compounding Advisory Committee (PCAC) One current vacancy Efforts to get Stakeholders on the PCAC Nomination Process and Support Letters Congressional PCAC Letters PCAC FY 2018 Appropriations Request More stakeholder input/members that have diverse, recent, and actual experience with compounding More involvement of stakeholders during the meetings Formal Rulemaking process for all three lists Inspection Outlook: Current trends of FDA Inspections and Findings FDA aggressively inspecting - Increase in ALL inspections including hospitals and health systems Compounding - issuing Form 483s and Warning Letters for compounding medications The FDA Compounding: Inspections, Recalls, and other Actions web page lists 6 recent 483s for hospital pharmacies 15 Form 483s were just issued to hospitals and health systems for Medical device MedWatch Reports Result: 483s, Warning Letters, fines, recalls, cease sterile production and media coverage 12

13 FDA Notice of Change in Inspection Policy Published in July 2016, effective August 1, 2016 Required preliminary determination from inspectors All facilities will be held to insanitary conditions Many questions still exist How will Insanitary conditions be determined and cited within the 483s and Warning Letters? How will status of facility be determined? Will the Section 704 records exemption be preserved? What is the inspection standard? Stakeholders Efforts Congressional Bipartisan Office-Use Letters Stewart/Cuellar Letter = 60 bipartisan signatures Stewart/Carter Letter = 65 bipartisan signatures Congressional MOU Letters and Comments PCAC Letters and Comments Congressional hearing questions to FDA and HHS 13

14 Stakeholder s Efforts Questions during Confirmation of Commissioner Gottlieb Congressional Questions for the Record Appropriations Report Language (chart with comparison of all language for FY16-FY18) Federal Legislation (HR 2871) Congressional Recess Meeting Co-Host Other Local Events Congressional Briefing in Washington, DC Congressional Meetings with Commissioner Gottlieb Congressional Dear Colleagues in Follow-up to the Appropriations Effort Congressional Letters RE FDA third category for 503As to register as 503B DQSA fix legislation HR2871 Preserving Patient Access to Compounded Medications Act of 2017 Bipartisan - Griffith(VA)/Cuellar(TX) Office-use clarification of state authority to allow office-use MOU Removes dispense from the MOU Inspection authority records exemption for compounding pharmacists Registration exemption for compounding pharmacists Monograph fixes dietary supplements PCAC requirements Regulation formal rulemaking process with stakeholder input and FDA responses in rules 14

15 Next Steps We Need YOUR Help! Now that HR 2871 legislation has been introduced even more grassroots is necessary Need additional bill cosponsors in House Need companion Senate bill Patient Advocacy Website It s Launched! Please send patients, prescribers and pharmacists here! Contains Voter Voice grassroots capabilities Allows sharing of stories about patient access with Congress 150,000 advocates so far! Check it out! Let your prescribers and patients know about the bill! Thank You! 15

16 Cynthia Blankenship, Esq Executive Vice President International Academy of Compounding Pharmacists 16

17 Disclosure Jon Pritchett, Pharm.D., RPh., Associate Director, Pharmacy, Accreditation Commission for Healthcare declares no conflicts of interest or financial interest in any product or service mentioned in this program, including grants, employment, gifts, stock holdings, and honoraria. <800> Hazardous Drugs Handling in Healthcare Settings Published February 1, 2016 Implementation July 1, Implementation by who?... 17

18 Who enforces USP? State Board of Pharmacy Acceptance 12/50 states YES Under review in many states Proposed implementation: Partial adoption Delayed implementation Task force project Apply to sterile only? *Information provided courtesy of NASPA, current as of 8/9/

19 Federal Agencies and Civil Liability HD deficiencies have been mentioned in some FDA 483s OSHA OSHA Technical Manual Section VI: Chapter 2, Controlling Occupational Exposure to Hazardous Drugs has been archived and replaced New document contains: 209 references to USP 124 references to 800 Liability? The easi(er) things to do: Create a hazardous drug (HD) list Train staff and implement usage of safety data sheets Determine storage requirements for HDs Perform an assessment of risk where applicable Review PPE requirements What equipment is necessary? Shipping/transport/disposal 19

20 Harder things to do: Non sterile facility requirements: Harder things to do: Sterile facility requirements: 20

21 Where to begin? Be familiar with <800> and current NIOSH publication (2016) Prepare and train staff Create a hazardous drug list Assess facilities compliant for services offered? Or Jon Pritchett, Pharm.D., RPh. Associate Director, Pharmacy Accreditation Commission for Healthcare jpritchett@achc.org