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A Matter of Record

(301) 890-4188

1

FOOD AND DRUG ADMINISTRATION 1

CENTER FOR DRUG EVALUATION AND RESEARCH 2

3

4

5

6

7

PHARMACY COMPOUNDING ADVISORY COMMITTEE (PCAC) 8

Morning Session 9

10

Thursday, November 3, 2016 11

8:31 a.m. to 12:05 p.m. 12

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14

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FDA White Oak Campus 18

10903 New Hampshire Avenue 19

Building 31 Conference Center 20

The Great Room (Rm. 1503) 21

Silver Spring, Maryland 22

A Matter of Record

(301) 890-4188

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Meeting Roster 1

DESIGNATED FEDERAL OFFICER (Non-Voting) 2

Cindy Hong, PharmD 3

Division of Advisory Committee and Consultant Management 4

Office of Executive Programs, CDER, FDA 5

6

PHARMACY COMPOUNDING ADVISORY COMMITTEE MEMBERS (Voting) 7

Michael A. Carome, MD, FASHP 8

(Consumer Representative) 9

Director of Health Research Group 10

Public Citizen 11

Washington, District of Columbia 12

13

Gigi S. Davidson, BSPh, DICVP 14

(U.S. Pharmacopeial Convention Representative) 15

Director of Clinical Pharmacy Services 16

North Carolina State University 17

College of Veterinary Medicine 18

Raleigh, North Carolina 19

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21

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A Matter of Record

(301) 890-4188

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John J. DiGiovanna, MD 1

Senior Research Physician 2

DNA Repair Section 3

Dermatology Branch 4

Center for Cancer Research 5

National Cancer Institute 6

Bethesda, Maryland 7

8

Padma Gulur, MD 9

(Acting Chairperson) 10

Vice Chair, Operations and Performance 11

Duke University School of Medicine 12

Department of Anesthesiology 13

Durham, North Carolina 14

15

Stephen W. Hoag, PhD 16

Professor 17

Department of Pharmaceutical Science 18

University of Maryland, Baltimore 19

Baltimore, Maryland 20

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A Matter of Record

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Katherine Pham, PharmD, BCPS 1

Senior Officer 2

Drug Safety Project 3

The Pew Charitable Trusts 4

Washington, District of Columbia 5

6

Allen J. Vaida, BSc, PharmD, FASHP 7

Executive Vice President 8

Institute for Safe Medication Practices 9

Horsham, Pennsylvania 10

11

Donna Wall, PharmD 12

(National Association of Boards of Pharmacy 13

Representative) 14

Clinical Pharmacist 15

Indiana University Hospital 16

Indianapolis, Indiana 17

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A Matter of Record

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PHARMACY COMPOUNDING ADVISORY COMMITTEE MEMBERS 1

(Non-Voting) 2

Ned S. Braunstein, MD 3

(Industry Representative) 4

Senior Vice President and Head of Regulatory 5

Affairs 6

Regeneron Pharmaceuticals, Inc. 7

Tarrytown, New York 8

9

William Mixon, RPh, MS, FIACP 10

(Industry Representative) 11

Former Owner 12

The Compounding Pharmacy 13

Hickory, North Carolina 14

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A Matter of Record

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C O N T E N T S 1

AGENDA ITEM PAGE 2

Call to Order and Introduction of Committee 3

Padma Gulur, MD 8 4

Conflict of Interest Statement 5

Cindy Hong, PharmD 13 6

FDA Introductory Remarks 7

Emily Gebbia, JD 18 8

503A Bulk Drug Substances List 9

FDA Presentation 10

Glycolic Acid 11

Jane Liedtka, MD 21 12

Clarifying Questions from the Committee 34 13

Nominator Presentation 14

John Voliva, RPh 41 15

Open Public Hearing 42 16

Committee Discussion and Vote 17

503A Bulk Drug Substances List 18

FDA Presentation 19

Trichloroacetic Acid 20

Roselyn Epps, MD 56 21

22

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C O N T E N T S (continued) 1

AGENDA ITEM PAGE 2

Clarifying Questions from the Committee 65 3

Nominator Presentation 4

A.J. Day, PharmD 66 5

Clarifying Questions from the Committee 70 6

Open Public Hearing 86 7

Committee Discussion and Vote 95 8

503A Bulk Drug Substances List 9

FDA Presentation 10

Kojic Acid 11

Jonathan Jarow, MD 114 12

Clarifying Questions from the Committee 128 13

Nominator Presentation 14

Tom Wynn, RPh 132 15

Clarifying Questions from the Committee 145 16

Open Public Hearing 157 17

Committee Discussion and Vote 174 18

Adjournment 180 19

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A Matter of Record

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P R O C E E D I N G S 1

8:31 a.m. 2

Call to Order 3

Introduction of Committee 4

DR. GULUR: Good morning, everyone. I would 5

first like to remind everyone present to please 6

silence your cell phones, Blackberrys, and other 7

devices if you have not already done so. I would 8

also like to identify the FDA press contact for 9

this open session meeting, Ms. Lyndsay Meyer. If 10

you are present, please stand. 11

Good morning. My name is Padma Gulur. I am 12

the acting chairperson of the Pharmacy Compounding 13

Advisory Committee, otherwise referred to as PCAC. 14

I will now call the committee to order. We will 15

now ask that those at the table, including FDA 16

staff and committee members, to introduce 17

themselves, starting with the FDA to my far left 18

and moving along to the right side, ending with one 19

of the industry representatives, Dr. Braunstein. 20

DR. GANLEY: Charlie Ganley. I'm the 21

director of Office of Drug Evaluation IV in the 22

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Office of New Drugs at CDER. 1

MS. GEBBIA: Emily Gebbia. I'm a senior 2

advisor in CDER's Office of Compliance and the 3

acting agency lead on compounding. 4

MS. BORMEL: I'm Gail Bormel. I'm in CDER's 5

Office of Compliance, the Office of Unapproved 6

Drugs and Labeling Compliance. 7

MR. FLAHIVE: I'm Jim Flahive. I'm a 8

regulatory counsel in CDER Compliance Office of 9

Unapproved Drugs and Labeling Compliance. 10

DR. LAWSON: I'm Rosilend Lawson. I'm a 11

regulatory counsel in CDER's Office of Compliance 12

as well. 13

DR. KO: I am Hon-Sum Ko, medical officer in 14

dermatology and dental drugs products division in 15

the Office of New Drugs. 16

DR. EPPS: Good morning. I'm Dr. Roselyn E. 17

Epps. I'm a clinical reviewer in the Division of 18

Dermatology and Dental Products. 19

DR. LIEDTKA: I'm Jane Liedtka, medical 20

officer here at the FDA. 21

DR. HONG: I'm Cindy Hong, designated 22

A Matter of Record

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federal officer for PCAC. 1

MS. DAVIDSON: I'm Gigi Davidson, and I 2

represent the United States Pharmacopeia. 3

DR. DiGIOVANNA: I'm John DiGiovanna. I'm a 4

dermatologist at the National Cancer Institute, 5

NIH. 6

DR. HOAG: I'm Steve Hoag. I'm a professor 7

at the University of Maryland School of Pharmacy. 8

DR. CAROME: I'm Mike Carome, director of 9

Public Citizen's Health Research Group. 10

DR. WALL: I'm Donna Wall, clinical 11

pharmacist at University Hospital in Indianapolis 12

and represent NABP. 13

DR. VAIDA: Allen Vaida, and I'm a 14

pharmacist and executive vice president at the 15

Institute for Safe Medication Practices. 16

MR. MIXON: Good morning. Bill Mixon, 17

former owner of The Compounding Pharmacy, Hickory, 18

North Carolina; and also member of the North 19

Carolina Board of Pharmacy; member of the USP 20

Expert Committee for Compounding; and surveyor for 21

ACHC. 22

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DR. BRAUNSTEIN: Ned Braunstein. I'm the 1

head of regulatory affairs at Regeneron 2

Pharmaceuticals, and I'm the pharmaceutical and 3

biotechnology industry representative. 4

DR. GULUR: Thank you, everyone 5

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