disclosure - ncpa · • those that should not register: if the fa cility’s activities only...
TRANSCRIPT
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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.
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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, PharmDVP, Pharmacy Affairs
NCPA
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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
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Top 5 Things for Compounders to Keep on Your Radar1. 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)
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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 (07.11.16):
• “(i.e., human drug compounders that are not registered with FDA as outsourcing facilities under section 503B).
Thank You!
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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.
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Regulatory Outlook: FDA Implementation of the DQSAFDA 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: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm166743.htm
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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
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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.
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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).”
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FDA Efforts with State Boards of Pharmacy
• State required to take “appropriate action.”
• State required to notify FDA via email 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)
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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
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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
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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
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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! http://p3rx.org/
Let your prescribers and patients know about the bill!
Thank You!
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Cynthia Blankenship, EsqExecutive Vice PresidentInternational Academy of
Compounding [email protected]
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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, 2018
• ….. Implementation by who?....
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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 8/9/2017
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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
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Harder things to do:
• Non‐sterile facility requirements:
Harder things to do:
• Sterile facility requirements:
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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 [email protected]
919‐785‐1214