2015 Annual Convention

Transcription

1 2015 Annual Convention Date: Monday, October 12, 2015 Time: 4:00 pm 5:30 pm Location: Gaylord National Harbor Resort and Convention Center, National Harbor 10 Title: Activity Type: Speaker: Compounding Legal, Regulatory & Quality Practice Update: What Pharmacies Need to Know Now ACPE # L03-P 0.15 CEUs ACPE # L03-T Application-based Rachael Pontikes, Partner, Duane Morris, LLP A.J. Day, PharmD, RPh, Director, Pharmacy Consulting, PCCA Ronna Hauser, PharmD, Vice President of Pharmacy Affairs, NCPA Pharmacist and Pharmacy Technician Learning Objectives: Upon completion of this activity, participants will be able to: 1. Discuss the current position of the FDA on compounding and the ramifications for your compounding practice. 2. Explain how the memorandum of understanding addressing interstate shipment of compounds is being enforced and potential practice effects for compounding pharmacies. 3. Discuss the rights of the pharmacy related to FDA s inspection activities. Disclosures: Rachael Pontikes is a Partner with Duane Morris, LLP. The conflict of interest was resolved by peer review of the slide content. A.J. Day is the Director of Pharmacy Consulting with PCCA. The conflict of interest was resolved by peer review of the slide content. Ronna Hauser 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. NCPA s education staff 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. NCPA is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. This program is accredited by NCPA for 0.15 CEUs (1.5 contact hours) of continuing education credit.

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3 Compounding Legal, Regulatory & Quality Practice Update: What Pharmacies Need to Know Now Ronna B. Hauser, PharmD, Vice President of Pharmacy Affairs, NCPA, Alexandria, Virginia Disclosures Rachael Pontikes is a Partner with Duane Morris, LLP. The conflict of interest was resolved by peer review of the slide content. A.J. Day is the Director of Pharmacy Consulting with PCCA. The conflict of interest was resolved by peer review of the slide content. Ronna Hauser 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. Learning Objectives 1. Discuss the current position of the FDA on compounding and the ramifications for your compounding practice. 2. Explain how the memorandum of understanding addressing interstate shipment of compounds is being enforced and potential practice effects for compounding pharmacies. 3. Discuss the rights of the pharmacy related to FDA s inspection activities. 1

4 Agenda 2013 Drug Quality and Security Act (DQSA) Compounding Provisions Implementation Timeline FDA Pharmacy Compounding Advisory Committee (PCAC) Maintaining a quality compounding practice FDA s implementation of the DQSA compounding law from a legal standpoint DQSA Where are We Now? NCPA Focused on 503A Implementation 12/4/13: FDA Seeks Nominations for 503A and 503B Drug Products that Present Demonstrable Difficulties for Compounding 12/4/13 and 7/2/14: FDA Seeks Nominations for 503A Bulk Substances 7/2/14: FDA Releases Updated Final 503A Guidance 7/2/14: Proposed rule re Withdrawn/Removed List 2/13/15: FDA Releases Draft Repackaging Guidance 2/13/15: FDA Releases Draft MOU 3/6/15:FDA Opens Public Compounding Docket Final 503A Guidance FDA s guidance documents do not establish legally enforceable responsibilities but describe the Agency s current thinking on a topic 503A pharmacies exempt from the following (1) section 501(a)(2)(B) (concerning current good manufacturing practice); (2) section 502(f)(1) (concerning the labeling of drugs with adequate directions for use); and (3) section 505 (concerning the approval of drugs under new drug applications (NDAs) or abbreviated new drug applications (ANDAs)) 10 conditions must be met for the compounded drug product to qualify for the exemptions 2

5 Final 503A Guidance Outstanding 503A issues: 1. Withdrawn/Removed List: FDA intends to update this list periodically, and expects compounders to comply with the list as it currently exists and with any final updates. 2. Bulk Drug Substances List: Until a bulk drug substances list is published in the Federal Register as a final rule, human drug products should be compounded using only bulk drug substances that are components of drugs approved under section 505 of the FD&C Act, or are the subject of USP or NF monographs. Final 503A Guidance Outstanding 503A issues: 3. Demonstrable Difficulties for Compounding: This provision is not enforceable until FDA promulgates an implementing regulation. 4. Memorandum of Understanding Between FDA and the States: FDA does not intend to enforce the 5% limit on interstate distribution until after FDA has finalized an MOU and made it available to the states for their consideration and signature. NCPA Comments 503A Draft Guidance 503A Bulk Substances List Round 2 comments 40 substances submitted All nominations are bulk substances currently used by compounding pharmacies that are not the subject of a USP or NF monograph nor are they components of approved products NCPA strongly recommends that FDA consult with the PCAC related to every single submission the Agency receives 3

6 NCPA Comments Draft MOU FDA has proposed that an inordinate amount of compounded human drug products has been distributed interstate if the number of units of compounded human drug products distributed interstate during any calendar month is equal to or greater than 30% of the number of units of compounded and non compounded drug products distributed or dispensed both intrastate and interstate during that month. NCPA opposed to (1) Defining distribution to include dispensing (2) Prohibiting all office use compounding by 503A pharmacies (3) Placing an arbitrary cap on patient specific compounds shipped interstate (4) requirements that FDA is placing on state boards of pharmacy NCPA Comments Draft Repackaging Guidance Limits the amount of product that a pharmacy can repackage at one time (14 days) LTC Pharmacy Concerns: impact on medication cabinets, automated remote dispensing and first dose systems, emergency kits or crash carts, unit-dose cards All are pre-packaged with non-sterile solid oral doses of medication in advance of receipt of a patient specific prescription or chart order These activities are regulated by state and federal laws and regulations Listening Sessions DQSA Stakeholders Broad Group of Prescribers, Pharmacists and Patients DQSA Stakeholder Coalition Activities Office Use/Potential House Legislation Repackaging Appropriations Dietary Supplements Listening Session Response GAO report Vitter bill (S. 1406) Demonstrably Difficult List Vet Compounding TRICARE 4

7 FDA PCAC Members FDA Pharmacy Compounding Advisory Committee 14 Total Members 12 Voting 2 Non-voting Temporary Members may be voting members Chairperson Jurgen Venitz, MD, PhD Associate Professor, Virginia Commonwealth University School of Pharmacy, Department of Pharmaceutics Ned S. Braunstein, MD (Industry Rep) Senior Vice President and Head of Regulatory Affairs Regeneron Pharmaceuticals, Inc. Michael A. Carome, MD, FACP (Consumer Rep) Director, Health Research Group, Public Citizen FDA PCAC Members Gigi S. Davidson, BSPh, DICVP Director, Clinical Pharmacy Services, North Carolina State University College of Veterinary Medicine Robert DeChristoforo, MS, FASHP Chief, Clinical Center Pharmacy Department, National Institutes of Health John J. DiGiovanna, MD Staff Clinician, DNA Repair Section, Dermatology Branch, Center for Cancer Research Padma Gulur, MD Professor, University of California, Irvine Department of Anesthesiology and Perioperative Care FDA PCAC Members Stephen W. Hoag, PhD Professor, University of Maryland, Baltimore Department of Pharmaceutical Science William A. Humphrey, BSPharm, MBA, MS Director, Pharmacy Operations, St. Jude Children s Research Hospital Elizabeth Jungman, JD Director, Public Health Programs, The Pew Charitable Trusts William Mixon, RPh, MS, FIACP (Industry Rep) Owner-Manager, The Compounding Pharmacy 5

8 FDA PCAC Members Katherine Pham, PharmD, BCPS Neonatal Intensive Care Unit Pharmacy Specialist Children s National Medical Center Allen J. Vaida, BSc, PharmD, FASHP Executive Vice President, Institute for Safe Medication Practices Donna Wall, PharmD Clinical Pharmacist, Indiana University Hospital FDA PCAC FDA Pharmacy Compounding Advisory Committee 1 st meeting February 23-24, 2015 withdrawn/removed list, 503A bulk substances list (64 total to be considered) 2 nd meeting June 17-18, 2015 expanded access to investigational drugs, withdrawn/removed list, 503A bulk substances list, proposed criteria for demonstrably difficult list 3 rd meeting Late October 2015 What Pharmacies Need to Know Now A.J. Day, PharmD, RPh Director, Pharmacy Consulting PCCA 6

9 503A, Day-to-Day Operations Votes from PCAC YES 1. Acetyl-D-Glucosamine 2. Brilliant Blue G 3. Cantharidin 4. DPCP 5. Squaric Acid Dibutyl Ester 6. Tranilast NO 1. 5-HTP (Oxitriptan) 2. Piracetam 3. Silver Protein Mild 4. Thymol Iodide So can you compound with those materials? YES What about the NO votes? As of now YES FDA has not released final decisions on any materials from PCAC meetings 7

10 Other 503A changes to daily ops Office use FDA opinion is HR 3204 limits 503A pharmacies to patient-specific prescriptions Congressional intent says this issue was to be left to the individual states Shipping to other states (FDA proposal) If you want to ship to other states, you are limited to 5% of your prescription volume going out of state OR your BOP must enter into MOU with FDA, which then allows 30% MOU current implications FDA has stated they will not enforce any MOU until 6 months after finalizing the documents. 3,052 public comments submitted as of 9/ N-1459 Continuous Quality Improvement QA/QC in the pharmacy Documentation in compliance with USP and BOP Test results potency, sterility, endotoxin, method suitability SOP for each procedure, all staff involved with those procedures Certificates of Analysis have them, know what to look for 8

11 Proper Wholesaler Chemical Pathway ABCs are What You Need Documentation SOP Equipment calibration logs, cleaning, gowning COA DFW Mix Well? CQI Self assessments, training logs Gowning Violations Bare arms No gloves No mask Misused gloves This is for YOUR safety 9

12 USP <795> Transfer of Materials for Use Within the Pharmacy Component name Supplier Lot number Transfer date EXP date If no EXP date is provided then 3 years from date of receipt Integrity of new container must be equal to, or better than, original container Coming Soon Updates to USP <797> Sterile compounding New USP <800> Hazardous drug compounding Sterile & non sterile FDA GFI #230 Veterinary Medicine HR 3204 only applies to human medicine GFI #230 seeks to apply several components to veterinary compounding Subverts legal process Adds significant documentation burden to both veterinarians and pharmacists Would make it illegal to compound from bulk for food-producing animals Broad definition of food animals 10

13 BOP primary mission Protect Public Health Execute recall procedure to patient level Comply with state rules & regulations Your state and others you ship to FDA rules Compounding: What Pharmacies Need to Know Office Use Under Section 503A Language of Section 503A FDA Position Enforcement Activities 11

14 Memorandum of Understanding Section 503A directs FDA to develop MOU Draft MOU Regulates All Pharmacy Practice Comment Period/Final MOU What happens now? Section 503A Positive List Section 503A requirements for bulk Criteria for positive list Recent developments FDA Inspections When FDA inspects pharmacies What happens during FDA inspections What happens post inspection Protocol for FDA inspection 12

15 ANY QUESTIONS? Rachael G. Pontikes, Esquire Phone: (312)