4/26/2013. Libia Lugo Drug Specialist San Juan District Office Investigations Branch
|
|
- Marybeth Cannon
- 6 years ago
- Views:
Transcription
1 Libia Lugo Drug Specialist San Juan District Office Investigations Branch The Food and Drug Administration (FDA) responsibilities extend to the 50 United States, the District of Columbia, Puerto Rico, Guam, the Virgin Islands, American Samoa, and other U.S. territories and possessions. There are five regional offices. They are located as follows: Northeast Region: Jamaica, NY and Stoneham, MA; Central Region: Chicago, IL and Philadelphia, PA; Southeast Region: Atlanta, GA; Southwest Region: Dallas, TX; and, Pacific Region: Oakland, CA. 1
2 FDA is responsible for protecting the public health by: Assuring that foods are safe, wholesome, sanitary and properly labeled; Assuring human and veterinary drugs, and vaccines are safe and effective Protecting the public from electronic product radiation (Radio emitting devices) Assuring cosmetics and dietary supplements are safe and properly labeled Regulating tobacco products FDA is also responsible: Takes the best informed decisions regarding the entry of the regulated products (i.e., food, drugs, devices) into the United States of FDAregulated products; FDA also participates in media with other countries to harmonize regulatory requirements Foods Dietary Supplements Human Drugs (OTC and prescription drug products) Vaccines, Blood Banks Medical Devices Electronic Products (microwave ovens and X-ray equipment, lights, and mammography facilities) Cosmetics Veterinary Products Tobacco Products 2
3 FDA does not regulate: alcoholic beverages illegal drugs of abuse, such as heroin and marijuana (except for the methadone which is regulated by FDA) meat and poultry (except for game meats, such as venison, ostrich, iguana, snake and others) restaurants and grocery stores (Retailers except upon request from the state on a case-by-case basis) San Juan District Office District Director Compliance Laboratory Investigations Administration San Juan Office Ponce RP Saint Thomas RP Aguada RP Devices Drugs Food Biologics Imports 3
4 210.3 Definitions (4) Drug product means a finished dosage form, for example, tablet, capsule, solution, etc., that contains an active drug ingredient generally, but not necessarily, in association with inactive ingredients. Active ingredient means any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man or other animals. The term includes those components that may undergo chemical change in the manufacture of the drug product and be present in the drug product in a modified form intended to furnish the specified activity or effect. Inactive ingredient means any component other than an active ingredient. Drug products are identified and reported using a unique number, called the National Drug Code (NDC). Bearing of this number on the label is voluntary FDA publishes the listed NDC numbers and the information submitted in the National Drug Code Directory at The NDC # does not mean the drug product is finally approved. 4
5 Drug Products regulated include: Prescription Drugs: Brand-name Drugs (a.k.a. Innovator Drugs) Bioequivalence Drug Products (a.k.a. Generic Drugs) Over-the-counter Drug Products The Prescription Drug Marketing Act of 1987 (PDMA) to ensure that drug products purchased by consumers are safe and effective, and to avoid the unacceptable risk to consumers from counterfeit, adulterated, misbranded, sub-potent, or expired drugs. This Act gives FDA authority to inspect establishments where finished drug products are sold such pharmacies, etc Generic drug products are similar/equivalent to the brand-name drug products. Applications for the generic drugs are also approved by the FDA as well as the brand drug products. Generic drugs are comparable to brand products in: Dosage form Strength route of administration Quality Performance characteristics Intended use 5
6 The generic drug must scientifically demonstrate that product performs in the same manner as the brand drug. For many products such as tablets and capsules, generics must show bioequivalence to the brandname referenced. The generic must deliver the same amount of active ingredient into a patient s bloodstream over the same time period as the brand-name reference listed drug. Studies in the bioavailability of the generic drug has to compare with the brand-name drug. Generic drug products use the same active pharmaceutical ingredients. Generic drugs go through the same approval review process. Have the same therapeutic equivalence, even though the generic drug may differ in certain other characteristics (e.g., shape, flavor, or preservatives). Manufacturers of generic drugs have to comply with the same standards and regulations Rx drug does. All approved drug products, the brandname and generic drug products, are listed in FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (a.k.a. Orange Book). 6
7 The generic drug products are less expensive than the brand drug products. Do not require new developmental work Do not require the preclinical (animal) and clinical (human) data to re-establish safety and effectiveness. Do not require marketing expenses About half of the generic drugs are manufactured by the brand name companies. Generic equivalent of brand-name drugs can be found through Generic equivalents can be found through "Electronic Orange Book. Every drug will have some side effects. Since the FDA considers both the benefits and risks of all medications before approval, side effects are generally not serious and not necessarily manifest in every user. FDA require that labeling (package insert) outlines the benefits and risks reported in the tested population. 7
8 FDA encourages consumers and health professionals to notify FDA of any adverse side effects found when using drugs, by reporting them online to Medwatch. Ask to your health care provider to report the problem to FDA's MedWatch hotline, at 800-FDA-1088 or through MedWatch What to Report to MedWatch Any event that: is fatal. is life-threatening. is permanently/significantly disabling. requires or prolongs hospitalization. causes a birth defect. requires intervention to prevent permanent impairment or damage. Report all adverse events: Online through ( Mail, Downloading the form Fax For questions about the form:
9 FDA encourages the consumers to initiate complaints regarding the quality, problems and deviations known for any of the products regulated by the Agency. FDA is committed to investigate and take actions when necessary. Contact for Complaints: An establishment inspection is a careful, critical, official examination of a facility to determine its compliance with laws administered by FDA. Objectives: To determine whether the firms are in compliance with regulations (GMPs) To provide GMP orientation through the assessments made 9
10 Drug inspections are intended to monitor the production of the drug products through a comprehensive coverage of all aspects of the production which include: storage, manufacturing, packaging, testing, distribution and product behavior after distribution. Inspections are also used to obtain evidence to support legal action when violations are found. The regulations in this part and in part 211 applicable for drug products Sec. 21 Code for Federal Regulations Scope. (a) The regulations in this part contain the minimum current good manufacturing practice for preparation of drug products (excluding positron emission tomography drugs) for administration to humans or animals. Establishments must be registered within 5 days of beginning operations. (21 CFR (a) and and FD&C Act sections 510(c), (d), & (i)). 10
11 Drug Inspections could be: Comprehensive inspections Compliance Follow-up For Cause Inspections Typically, routine drug inspections are scheduled in a biennial basis. All drug manufacturers shall comply with the Good Manufacturing Practices (GMP) The regulations in this part contain the minimum current good manufacturing practice for preparation of drug products (excluding positron emission tomography drugs) for administration to humans or animals. The regulation is specified at the Code for Federal Regulations (21 CFR 211) Manufacturers Requirements: There shall be a quality control unit that shall have the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging material, labeling, and drug products. Review production records to assure that no errors have occurred during the processes. If errors have occurred, that they have been fully investigated. 11
12 Manufacturers Requirements: Personnel: Each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training, and experience, to enable that person to perform the assigned functions. There shall be an adequate number of qualified personnel to perform and supervise the manufacture, processing, packing, or holding of each drug product. Manufacturers Requirements: Storage: Storage of drug products under appropriate conditions of temperature, humidity, and light so that the identity, strength, quality, and purity of the drug products are not affected Manufacturers Requirements: Controls: Records shall be maintained for all components, drug product containers, closures, and labeling for at least 1 year after the expiration date or, 12
13 Manufacturers Requirements: Control records shall be prepared for each batch of drug product produced and shall include complete information relating to the production and control of each batch. (1) Dates; (2) Equipment (3) Specific identification of each lot of materials (4) Weights and measures of components used in the course of processing; (5) In-process and laboratory control results; (6) Inspection of the packaging and labeling area before and after use; (7) Identification of the persons performing and checking each significant step in the operation (8) Resolution of any investigation made During the inspection, conditions deemed to be objectionable are listed on an FDA Form 483. The observed conditions or practices indicate that an FDA-regulated product may be in violation of FDA s requirements. Untitled Letters, Warning Letters, and Regulatory Meetings 13
14 FDA has the practice to give individuals and firms an opportunity to take voluntary and prompt corrective action before it initiates an enforcement action. Prior notice is a basic principle. Advisory notice tools include: FDA-483 Form- Inspectional Observations, Verbal Observations, untitled letters, regulatory meetings, and warning letters. Enforcement (judicial) actions Administrative actions Import actions Primary intention is to put the firm on notice of deviations from the regulations and achieving prompt voluntary compliance with the Federal Food, Drug, and Cosmetic Act (the Act). It notifies the regulated industry about violations that FDA has documented during the routine and directed inspections or investigations. Warning Letters are issued only for violations of regulatory significance. The Agency will take enforcement action without a Warning Letter under these situations: The violation reflects a history of repeated or continual conduct of a similar nature; The violation is intentional, The violation presents a reasonable possibility of injury or death in the consumers, When adequate prior notice has been given and the violations have not been corrected. 14
15 CFR - Code of Federal Regulations Title 21 atwww.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcf R/CFR Regulatory Procedures Manual at oceduresmanual/default Staff Manual Guides at ManualGuides/default CP Drug Manufacturer Inspections ComplianceProgramManual/ucm
Raritan Pharmaceuticals, Inc. 6/20/17
Raritan Pharmaceuticals, Inc. 6/20/17 U.S. Food & Drug Administration Division of Pharmaceutical Quality Operations I New Jersey District 10 Waterview Boulevard, 3rd Floor Parsippany, NJ 07054 June 20,
More informationFDA Sampling Guidance and Practices. Terri McConnell FDA/ORA/Office of Regulatory Science
FDA Sampling Guidance and Practices Terri McConnell FDA/ORA/Office of Regulatory Science Background and General Information Mission of the Food and Drug Administration (FDA) Major Laws Enforced by the
More informationMitch Zeller, Director, Center for Tobacco Products, FDA September 19, 2013 Kansas Public Health Association
Regulatory Public Laws Compliance & Education Policies Science & Enforcement & Communications The FDA Center for Tobacco Products (CTP): Its Role in Reducing Tobacco Use Mitch Zeller, Director, Center
More informationDEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Apini$r$iy -tq 5-f
DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Apini$r$iy -tq 5-f J Dallas District 4040 North Central Expressway Dallas, Texas 75204-3145 Ref: 2004-DAL-WL-03 WARNING LETTER CERTIFIED MAIL RETURN
More informationPublic Health Service Food and Drug Administration San Francisco District 1431 Harbor Bay Parkway Alameda, CA Telephone: 510/
Department of Health and Human Services Public Health Service Food and Drug Administration San Francisco District 1431 Harbor Bay Parkway Alameda, CA 94502-7070 Telephone: 510/337-6700 WARNING LETTER December
More informationGuidance for Industry DRAFT GUIDANCE. This guidance document is being distributed for comment purposes only.
Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry DRAFT GUIDANCE This guidance
More informationTeva Pharmaceuticals USA Attention: Scott D. Tomsky Vice President, US Generics Regulatory Affairs 425 Privet Road Horsham, PA 19044
DEPARTMENT OF HEALTH & HUMAN SERVICES ANDA 090783 Food and Drug Administration Silver Spring, MD 20993 Teva Pharmaceuticals USA Attention: Scott D. Tomsky Vice President, US Generics Regulatory Affairs
More informationTSDR Pharmacy Inc. dba brandmd Skin Care 11/9/17
TSDR Pharmacy Inc. dba brandmd Skin Care 11/9/17 Division of Pharmaceutical Quality Operations IV 19701 Fairchild, Irvine, CA 92612-2506 Telephone: 949-608-2900 Fax: 949-608-4417 WARNING LETTER VIA SIGNATURE
More informationOverview of Dietary Supplement GMP Inspection Trends Quality Session 6
Overview of Dietary Supplement GMP Inspection Trends Quality Session 6 Presented by: Dean R. Cirotta, MBA President & Chief Operating Officer EAS Consulting Group, LLC 1700 Diagonal Road, Suite 750 Alexandria,
More informationBorder Issues and Statistics: Regulatory Activities. Mr. Robert Deininger Southwest Import Director AFDO San Antonio, Texas
Border Issues and Statistics: Regulatory Activities Mr. Robert Deininger Southwest Import Director AFDO San Antonio, Texas U.S. Food & Drug Administration Mission Statement The Food & Drug Administration
More informationFDA Laws & Pharmacy Practice
Objectives FDA Laws & Pharmacy Practice Tom Hazlet Pharmacy 543 October 6, 2004 Be able to discuss the evolution of food and drug law in the United States Be able to discuss the ways in which pharmacists
More informationRock Solid Nutrition, LLC 12/22/16
Rock Solid Nutrition, LLC 12/22/16 December 22, 2016 WARNING LETTER Kansas City District Office 8050 Marshall Drive - Suite 205 Lenexa, Kansas 66214-1524 913-495-5100 VIA UNITED PARCEL SERVICE OVERNIGHT
More informationFDA Basics FDA s Import Operations: How FDA Regulates Imported Products
FDA Basics FDA s Import Operations: How FDA Regulates Imported Products Carlos W. Hernandez Compliance Officer U.S. Food and Drug Administration Global Regulatory Operations and Policy Office of Regulatory
More informationInspections, Compliance, Enforcement, and Criminal Investigations
Page 1 of 5 Home Inspections, Compliance, Enforcement, and Criminal Investigations Enforcement Actions Warning Letters Inspections, Compliance, Enforcement, and Criminal Investigations V-SAB Medical Labs,
More informationStonegate Pharmacy LP 11/10/16
Stonegate Pharmacy LP 11/10/16 November 10, 2016 2017 DAL WL 03 WARNING LETTER UPS Overnight Rene F. Garza, Pharm.D., Chief Executive Officer Stonegate Pharmacy, LP 2501 W. William Cannon Drive, Suite
More informationFDA Laws & Pharmacy Practice
Objectives FDA Laws & Pharmacy Practice Tom Hazlet Pharmacy 543 Autumn 2006 Be able to discuss the evolution of food and drug law in the United States Be able to discuss the ways in which pharmacists and
More informationOptimum Bioenergy International Corp. 12/21/17
Optimum Bioenergy International Corp. 12/21/17 Office of Human and Animal Food Division 5 West 1431 Harbor Bay Parkway Alameda, CA 94502-7070 Sent Via UPS Signature Required WARNING LETTER December 21,
More informationPublic Health Service Food and Drug Administration Dallas District 4040 North Central Expressway Dallas, Texas
Department of Health and Human Services Public Health Service Food and Drug Administration Dallas District 4040 North Central Expressway Dallas, Texas 75204-3128 March 30, 2010 2010-DAL-WL-08 CERTIFIED
More informationInspections, Compliance, Enforcement, and Criminal Investigations
Page 1 of 9 Inspections, Compliance, Enforcement, and Criminal Investigations Phoenix Medical Devices, LLC 9/29/2009 Department of Health and Human Services Public Health Service Food and Drug Administration
More informationReishi D. International, Inc. 2/6/18
Reishi D. International, Inc. 2/6/18 San Francisco District Office 1431 Harbor Bay Parkway Alameda, CA 94502-7070 Via UPS Overnight February 7, 2018 Mr. Zheng Xiong Li, CEO Reishi D. International, Inc.
More informationLopez Gonzalez Santana Corporation dba Domel and dba Dermixx 8/28/17
Lopez Gonzalez Santana Corporation dba Domel and dba Dermixx 8/28/17 Office of Human and Animal Food Operations East Division IV Compliance Branch 466 Avenida Fernández Juncos San Juan, Puerto Rico 00901-3223
More informationInspections, Compliance, Enforcement, and Criminal Investigations
Page 1 of 6 Home Inspections, Compliance, Enforcement, and Criminal Investigations Enforcement Actions Warning Letters Inspections, Compliance, Enforcement, and Criminal Investigations P.A. Benjamin Manufacturing
More informationPlanning For The FDA s 'Deeming Rule' For E- Cigarettes
Law360, New York (September 21, 2015, 3:39 PM ET) -- The 2009 Family Smoking Prevention and Tobacco Control Act (TCA)[1] gave the U.S. Food and Drug Administration the authority to oversee the manufacture,
More informationRequirements to the Registration of Medicinal products in the Republic of Armenia
Requirements to the Registration of Medicinal products in the Republic of Armenia Yerevan 2010 Requirements to the Registration of Medicinal products in the Republic of Armenia Current requirements to
More informationTown and Country Compounding and Consultation Services, LLC 10/17/17
Town and Country Compounding and Consultation Services, LLC 10/17/17 Division of Pharmaceutical Quality Operations I 10 Waterview Blvd, 3rd FL Parsippany, NJ 07054 Telephone: (973) 331-4900 FAX: (973)
More informationResidual Solvents: FDA/ Regulatory Perspective
Rosa Motta Compliance Officer Residual Solvents: FDA/ Regulatory Perspective PDA/USP Residual Solvents Conference January 18-19, 2007 1 Outline Laws and regulations governing the compliance requirements
More informationSandoz Inc. 12-Aug-08
Sandoz Inc. 12-Aug-08 Department of Health and Human Services Public Health Service Food and Drug Administration Atlanta District Office 60 8th Street, N.E. Atlanta, Georgia 30309 August 12, 2008 VIA FEDERAL
More information247 CMR BOARD OF REGISTRATION IN PHARMACY
247 CMR 18.00: NON-STERILE COMPOUNDING Section 18.01: Authority and Purpose 18.02: Non-Sterile Compounding Process 18.03: Non-Sterile Compounding Facility 18.04: Non-Sterile Compounding Equipment 18.05:
More informationcgmp (21 CFR 111) Regulation and Compliance Overview
cgmp (21 CFR 111) Regulation and Compliance Overview Neogen Effective Compliance Seminar September 23, 2014 Michael McGuffin President, American Herbal Products Association mmcguffin@ahpa.org Regulation
More informationOverview of FDA Oversight and Enforcement on Drug Compounding
Overview of FDA Oversight and Enforcement on Drug Compounding Ruey Ju, Pharm.D., J.D. Senior Advisor for Compounding Compliance and Enforcement (Acting) Center for Drug Evaluation and Research Today s
More informationSouthern California Section & Western Compendial Discussion Group
Association for Official and Analytical Chemists Southern California Section & Western Compendial Discussion Group October 6, 2011 Compliance Officer Bill Vitale, Food and Drug Administration Los Angeles
More informationIN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF NEW MEXICO ) ) ) ) ) ) ) ) ) INFORMATION. General Allegations. A. Introduction and Background
IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF NEW MEXICO UNITED STATES OF AMERICA, Plaintiff, vs. MOHAMED BASEL ASWAD, M.D., Defendant. CRIMINAL NO. 21 U.S.C. 331(a and 333(a(1: Introduction
More informationAKA Good Manufacturing Practice (GMP) Certification Program
AKA Good Manufacturing Practice (GMP) Certification Program Preamble The American Kratom Association (AKA) is establishing this program to assure the safety and integrity of kratom dietary supplements
More informationSan Diego Compounding Pharmacy 9/25/17
San Diego Compounding Pharmacy 9/25/17 Division of Pharmaceutical Quality Operations IV 19701 Fairchild Road Los Angeles, CA 92612 WARNING LETTER VIA UNITED PARCEL SERVICE SIGNATURE REQUIRED September
More informationAgency Information Collection Activities; Submission for Office of Management and Budget
This document is scheduled to be published in the Federal Register on 01/28/2016 and available online at http://federalregister.gov/a/2016-01690, and on FDsys.gov 4164-01-P DEPARTMENT OF HEALTH AND HUMAN
More informationResponsibilities of Laser Light Show Projector Manufacturers, Dealers, and Distributors; Final Guidance for Industry and FDA.
Responsibilities of Laser Light Show Projector Manufacturers, Dealers, and Distributors; Final Guidance for Industry and FDA (Laser Notice 51) Document issued on: May 27, 2001 U.S. Department of Health
More informationPreparing a US FDA Medical Device 510(K) Submission
Preparing a US FDA Medical Device 510(K) Submission If you want to introduce your medical device to the US market, you need to obtain clearance from the FDA. This clearance is obtained from the FDA via
More informationFood Commissaries under FSMA and the US FDA model Food Code
Food Commissaries under FSMA and the US FDA model Food Code Introduction A food commissary is a facility or operation that procures and/or produces foods intended for distribution. A retail or foodservice
More informationTaylor C. Wallace, PhD, CFS, FACN, March 22, 2018
Food Ingredients Taylor C. Wallace, PhD, CFS, FACN, March 22, 2018 Disclosures Think Healthy Group, Inc. George Mason University, Department of Nutrition and Food Studies Journal of the American College
More informationM I L L E R T H O M S O N LLP Barristers & Solicitors, Patent & Trade Mark Agents
M I L L E R T H O M S O N LLP Barristers & Solicitors, Patent & Trade Mark Agents Communiqué for Health Industry Clients on the Legal Retainer Program Canada s New Natural Health Products Regulations On
More informationInspections, Compliance, Enforcement, and Criminal Investigations
Page 1 of 6 Home Inspections, Compliance, Enforcement, and Criminal Investigations Enforcement Actions Warning Letters Inspections, Compliance, Enforcement, and Criminal Investigations A Nelson & Co.,
More informationBetter Health Lab, Inc 2/18/15
U.S. Food and Drug Administration Protecting and Promoting Your Health Better Health Lab, Inc 2/18/15 Department of Health and Human Services Public Health Service Food and Drug Administration New Jersey
More informationGuidelines for Product Recall or Withdrawal
REPUBLIC OF KENYA PHARMACY AND POISONS BOARD Guidelines for Product Recall or Withdrawal Edition 1 Date of release for publication June 2006 Date of implementation June 2006 This document has been prepared
More informationMedidée Services SA. Nano-Tera.ch. 05 February 2015 part 4. Intro ISO GMP - GLP Pierre-Alain Sommer
Nano-Tera.ch 05 February 2015 part 4 Intro ISO GMP - GLP Pierre-Alain Sommer Pierre-alain.sommer@medidee.com www.medidee.com Nano-Tera 2015 05.02.2015 Introduction to ISO 13485, cgmp s and GLP s Context
More informationRULES OF THE TENNESSEE BOARD OF PHARMACY CHAPTER DRUG DONATION REPOSITORY PROGRAM TABLE OF CONTENTS
RULES OF THE TENNESSEE BOARD OF PHARMACY CHAPTER 1140-17 DRUG DONATION REPOSITORY PROGRAM TABLE OF CONTENTS 1140-17-.01 Definitions 1140-17-.02 Purpose 1140-17-.03 Eligibility Criteria for Program Participation
More informationHealth Authority Abu Dhabi. Document Title: Policy for Recall of Drugs and Healthcare Products Document Ref. Number:
Health Authority Abu Dhabi Document Title: Policy for Recall of Drugs and Healthcare Products Document Ref. Number: PPR/DMP/DR/P0001 Version 0.9 Approval Date: August 2007 Effective Date: August 2007 Last
More informationAGREEMENT ON COMMON PRINCIPLES AND RULES OF CIRCULATION OF MEDICINAL PRODUCTS WITHIN THE EURASIAN ECONOMIC UNION. (Moscow, 23 December 2014)
AGREEMENT ON COMMON PRINCIPLES AND RULES OF CIRCULATION OF MEDICINAL PRODUCTS WITHIN THE EURASIAN ECONOMIC UNION (Moscow, 23 December 2014) Member States of the Eurasian Economic Union, hereinafter referred
More informationDraft Guidance for Industry and FDA Staff
Draft Guidance for Industry and FDA Staff Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile DRAFT GUIDANCE This guidance document
More informationTalon Compounding Pharmacy 10/3/17
Talon Compounding Pharmacy 10/3/17 Office of Pharmaceutical Quality Operations, Division II 4040 N. Central Expressway, Suite 300 Dallas, Texas 75204 October 3, 2017 CMS Case # 522630 VIA UPS EXPRESS WARNING
More informationFDLI s Enforcement, Litigation, and Compliance Conference. Center for Tobacco Products Office of Compliance and Enforcement 2017 Update
FDLI s Enforcement, Litigation, and Compliance Conference Center for Tobacco Products Office of Compliance and Enforcement 2017 Update Ann Simoneau, Director Office of Compliance and Enforcement Center
More informationUSP Perspective on Atypical Actives November 29, 2017
USP Perspective on Atypical Actives November 29, 2017 USP Excipients Stakeholder Forum USP Perspective on Atypical Actives Catherine Sheehan, M.S., M.S. Senior Director, Science Excipients Outline Role
More informationUsing and Referencing ISO and IEC Standards for Technical Regulation
Using and Referencing ISO and IEC Standards for Technical Regulation Third ANSI Conference on U.S. Leadership in ISO and IEC May 23-24, 24, 2007 Chicago, IL David P. Kelly, M.I.M. Office of International
More informationNaloxone Expanded Access: OTC status Considerations for a Nonprescription Drug Development Program
Naloxone Expanded Access: OTC status Considerations for a Nonprescription Drug Development Program Andrea Leonard-Segal, M.D., M.S. Director, Division of Nonprescription Clinical Evaluation 1 Contents
More informationINTRODUCTION TO DRUG LAW AND REGULATION: REGULATION OF DRUG MANUFACTURING
Food and Drug Law Institute's Workshop on INTRODUCTION TO DRUG LAW AND REGULATION: REGULATION OF DRUG MANUFACTURING November 8-9, 2010 Park Hyatt Hotel Washington, D.C. 1 REGULATION OF DRUG MANUFACTURING
More informationWhich was the greatest problem with patent medicines in early America that lead to drug legislation?
Pharmacology Connections to Nursing Practice 3rd Edition Adams Test Bank Full Download: http://testbanklive.com/download/pharmacology-connections-to-nursing-practice-3rd-edition-adams-test-bank/ Adams
More informationHieber's Pharmacy 12/5/17
Hieber's Pharmacy 12/5/17 Division of Pharmaceutical Quality Operations I 10 Waterview Blvd, 3rd FL Parsippany, NJ 07054 Telephone: (973) 331-4900 FAX: (973) 331-4969 CERTIFIED MAIL RETURN RECEIPT REQUESTED
More informationRESULTS AT A GLANCE. FDA Oversight of Tobacco Manufacturing Establishments. HHS OIG Data Brief August 2017 OEI
HHS OIG Data Brief August 2017 OEI-01-15-00300 FDA Oversight of Tobacco Manufacturing Establishments RESULTS AT A GLANCE The Tobacco Control Act authorized FDA to regulate domestic tobacco manufacturers
More informationGenetic Edge Compounds LLC 4/14/17
Genetic Edge Compounds LLC 4/14/17 April 14, 2017 2017 DAL WL 15 UPS Overnight Bradley N. Howard, Owner and CEO Genetic Edge Compounds, LLC (b)(6), (b)(7)(c) McKinney, Texas 75070 Mr. Howard: WARNING LETTER
More informationRecall Guidelines. for Chinese Medicine Products
Recall Guidelines for Chinese Medicine Products April 2018 Recall Guidelines for Chinese Medicine Products Chinese Medicines Board Chinese Medicine Council of Hong Kong Compiled in September 2005 1 st
More informationRoseann B. Termini, Esq.
Food Labeling and Food Safety Kind, Naked and Legal Issues... Do you Know who Really regulates Your Pizza and Where Your Beef is From? What is Smart About FOP Labelling? Roseann B. Termini, Esq. www.fortipublications.com
More informationTOBACCO PRODUCT OR MEDICAL PRODUCT?
TOBACCO PRODUCT OR MEDICAL PRODUCT? Priscilla Callahan-Lyon, MD Deputy Director Division of Individual Health Science Office of Science, CTP Grail Sipes, JD Director Office of Regulatory Policy, CDER Disclaimer:
More informationRE: Permits under the Arizona Pharmacy Act should not be required for dietary supplements
Board Members Arizona State Board of Pharmacy 1616 W. Adams St., Suite 120 Phoenix, AZ 85007 c/o Kam Gandhi, PharmD Executive Director Arizona State Board of Pharmacy Via email: kgandhi@azpharmacy.gov
More informationMARKETING STANDARDS FOR MEMBERSHIP
MARKETING STANDARDS FOR MEMBERSHIP The Vapor Technology Association (VTA) is a leading national trade association in the electronic cigarette and vapor product industry. VTA represents the manufacturers,
More informationFDLI ANNUAL CONFERENCE May 4, 2018
FDLI ANNUAL CONFERENCE May 4, 2018 DIETARY SUPPLEMENTS RETAILER ISSUES AND LIABILITY Jean Frydman, Partner, Chair FDA Practice Fox Rothschild, LLP FDA Concern is Safety Only DHSEA Act of 1994 Know what
More informationAFDO Conference June 9, Mercedes Mota, Director Medical Device, Surgical Care Johnson & Johnson Quality & Compliance Worldwide
AFDO Conference June 9, 2009 Mercedes Mota, Director Medical Device, Surgical Care Johnson & Johnson Quality & Compliance Worldwide Government Agencies 483 observations A violation of the FD&C Act involving
More informationMEDICINES CONTROL AGENCY GUIDELINE FOR REGISTRATION OF FOOD/NUTRITIONAL/DIETARY SUPPLEMENTS IN THE GAMBIA
MEDICINES CONTROL AGENCY GUIDELINE FOR REGISTRATION OF FOOD/NUTRITIONAL/DIETARY SUPPLEMENTS IN THE GAMBIA Document No.: MCA/NSG/17/11/01 Date of Adoption: 20 th January 2017 Date of Issue: 25 th July 2017
More informationOpiate Freedom Center 1/11/18
Opiate Freedom Center 1/11/18 UNITED STATES OF AMERICA DEPARTMENT OF HEALTH FEDERAL TRADE COMMISSION AND HUMAN SERVICES BUREAU OF CONSUMER FOOD AND DRUG ADMINISTRATION PROTECTION SILVER SPRING, MD 20993
More information51ST LEGISLATURE - STATE OF NEW MEXICO - FIRST SESSION, 2013
SENATE BILL ST LEGISLATURE - STATE OF NEW MEXICO - FIRST SESSION, 0 INTRODUCED BY Peter Wirth 0 AN ACT RELATING TO COMMERCE; AMENDING AND ENACTING SECTIONS OF THE NEW MEXICO FOOD ACT AND THE COMMERCIAL
More informationGeneral Concepts in the European Pharmacopoeia. Anne-Sophie Bouin European Pharmacopoeia Department, EDQM, Council of Europe
General Concepts in the European Pharmacopoeia Anne-Sophie Bouin European Pharmacopoeia Department, EDQM, Council of Europe General notices Anne-Sophie Bouin, 28/10/09 2009 EDQM, Council of Europe, All
More informationChapter 11 How to state your conditions clearly to the doctor
Chapter 11 How to state your conditions clearly to the doctor Chapter 11 How to state your conditions clearly to the doctor While seeing doctor, details of your statement should include the following:
More informationCDER Compliance Update
CDER Compliance Update Donald D. Ashley, JD 22 nd Annual GMP by the Sea August 30, 2017 www.fda.gov www.fda.gov 2 Office of Compliance Structure Office of Compliance Office of Drug Security, Integrity
More informationLIVE INTERACTIVE YOUR DESKTOP. Food Recall Process. Cecilia M. Wolyniak Food and Drug Administration Office of Enforcement
LIVE INTERACTIVE LEARNING @ YOUR DESKTOP Food Recall Process Cecilia M. Wolyniak Food and Drug Administration Office of Enforcement Wednesday, December 9, 2009 LEGAL ISSUES Code of Federal Regulations
More informationNew England Compounding Center 04-Dec-06
New England Compounding Center 04-Dec-06 Department of Health and Human Services Public Health Service Food and Drug Administration New England District One Montvale Avenue Stoneham, Massachusetts 02180
More informationCompare Results. 153 Replacements 26 Insertions 344 Deletions. Total Changes. Styling and. Content. 0 Annotations. Old File: New File:
3/1/2019 4:12:31 PM Compare Results Old File: Draft Guidance.pdf 20 pages (438 KB) 3/21/2018 3:55:17 PM versus New File: Final Guidance.pdf 21 pages (323 KB) 2/28/2019 11:42:05 AM Total Changes 523 Text
More informationChanges to the Eighth Edition
Pharmacy Practice and the Law, Eighth Edition Includes Navigate 2 Advantage Access By Richard R. Abood, BS Pharm, JD-Professor Emeritus Pharmacy Practice, Thomas J. Long School of Pharmacy and Health Sciences,
More informationH 7816 S T A T E O F R H O D E I S L A N D
LC00 01 -- H 1 S T A T E O F R H O D E I S L A N D IN GENERAL ASSEMBLY JANUARY SESSION, A.D. 01 A N A C T RELATING TO BUSINESSES AND PROFESSIONS - PHARMACIES Introduced By: Representatives Serpa, Canario,
More informationInspections, Compliance, Enforcement, and Criminal Investigations
Home Inspections, Compliance, Enforcement, and Criminal Investigations Enforcement Actions Warning Letters Inspections, Compliance, Enforcement, and Criminal Investigations Burzynski Research Institute
More informationDietary Supplement Health and Education Act of 1994 Public Law rd Congress
Dietary Supplement Health and Education Act of 1994 Public Law 103-417 103rd Congress An Act To amend the Federal Food, Drug, and Cosmetic Act to establish standards with respect to dietary supplements,
More informationPick and Pay Inc dba Cili Minerals 5/8/15
U.S. Food and Drug Administration Protecting and Promoting Your Health Pick and Pay Inc dba Cili Minerals 5/8/15 Department of Health and Human Services Public Health Service Food and Drug Administration
More informationStandards, Education, Verification. Patient Focused Certification
Standards, Education, Verification Patient Focused Certification PFC Training helps you achieve quality standards. Staff Certification is now available online www.pfctraining.org jahan@safeaccessnow.org
More informationC. No employee shall report to work or remain on duty while having a detectable blood alcohol concentration.
1 Series 3000 Personnel Section 3100 General Provisions Policy 3101 Drug Free Work Place File: 3101 3101.1 STATEMENT OF PURPOSE: The WV Board of Education and the Harrison County Board of Education recognize
More informationUNIVERSITY POLICY. Revised: Contact:
UNIVERSITY POLICY Policy Name: Policy for Controlled Substances Section #: 90.2.3 Section Title: Compliance Approval Authority: Responsible Executive: Responsible Office: Formerly Book: President Adopted:
More informationSub. S.B. 119 As Passed by the Senate
AM3404 Sub. S.B. 119 As Passed by the Senate Topic: Opioid Data and Communication Expansion Act moved to amend as follows: In line 1 of the title, after "4723.52," insert "4729.01, 4729.44, 4729.75, 4729.79,
More informationIC Chapter 10. Unlawful Sales
IC 7.1-5-10 Chapter 10. Unlawful Sales IC 7.1-5-10-0.1 Application of certain amendments to chapter Sec. 0.1. The addition of section 15.5 of this chapter by P.L.80-1986 does not apply to actions accruing
More informationCase 8:14-cv DKC Document 2-4 Filed 11/17/14 Page 1 of 17. Exhibit 3
Case 8:14-cv-03607-DKC Document 2-4 Filed 11/17/14 Page 1 of 17 Exhibit 3 Case 8:14-cv-03607-DKC Document 2-4 Filed 11/17/14 Page 2 of 17 Mallinckrodt: Chart Documenting Generic Substitution Laws for 50
More informationWINDBER AREA SCHOOL DISTRICT
No. 242 SECTION: STUDENTS WINDBER AREA SCHOOL DISTRICT TITLE: ADOPTED: May 7, 2014 CONTROLLED SUBSTANCES/PARAPHERNALIA REVISED: 242. CONTROLLED SUBSTANCES/PARAPHERNALIA 1. Purpose The Board recognizes
More informationGuidance for Industry
Guidance for Industry Dosage Delivery Devices for OTC Liquid Drug Products DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments and suggestions regarding this
More informationClinical Endpoint Bioequivalence Study Review in ANDA Submissions. Ying Fan, Ph.D.
Clinical Endpoint Bioequivalence Study Review in ANDA Submissions Ying Fan, Ph.D. 1 Disclaimer This presentation constitutes an informal communication that represents the best judgment of the speaker at
More informationThe Shifting Federal Regulation of Cannabis Products
The Durham Bar 2019 CLE Program The Shifting Federal Regulation of Cannabis Products Erica M. Jackson, FDA Partner K&L Gates February 6, 2019 Copyright 2018 by K&L Gates LLP. All rights reserved. OVERVIEW
More informationUse of Standards in Substantial Equivalence Determinations
Guidance for Industry and for FDA Staff Use of Standards in Substantial Equivalence Determinations Document issued on: March 12, 2000 U.S. Department Of Health And Human Services Food and Drug Administration
More informationChallenges and Opportunities: Implementing the Tobacco Control Act
Challenges and Opportunities: Implementing the Tobacco Control Act Lawrence R. Deyton, M.S.P.H., M.D. Director, Center for Tobacco Products April 5, 2011 1 To make tobaccorelated death and disease part
More informationSchedules of Controlled Substances: Temporary Placement of U into. AGENCY: Drug Enforcement Administration, Department of Justice.
This document is scheduled to be published in the Federal Register on 11/14/2016 and available online at https://federalregister.gov/d/2016-27357, and on FDsys.gov Billing Code 4410-09-P DEPARTMENT OF
More informationInspections, Compliance, Enforcement, and Criminal Investigations
Page 1 of 8 Home Inspections, Compliance, Enforcement, and Criminal Investigations Compliance Actions and Activities Warning Letters 2014 Inspections, Compliance, Enforcement, and Criminal Investigations
More informationGILMER COUNTY SCHOOLS Policy No POLICY MANUAL
GILMER COUNTY SCHOOLS Policy No. 4080 POLICY MANUAL TITLE: DRUG FREE WORKPLACE POLICY 1. General Policy. The Board believes it is imperative to establish, promote and maintain a safe, healthy working and
More informationMark M. Yacura. Partner
Mark M. Yacura Partner Mark M. Yacura focuses his practice primarily on FDA legal and regulatory matters. He has practiced in this area for more than 30 years. He represents his clients before administrative
More informationFSIS DIRECTIVE
UNITED STATES DEPARTMENT OF AGRICULTURE FOOD SAFETY AND INSPECTION SERVICE WASHINGTON, DC FSIS DIRECTIVE 7700.1 2-22-00 I. PURPOSE IRRADIATION OF MEAT AND POULTRY PRODUCTS This directive provides inspection
More informationFlexRx 6-Tier. SM Pharmacy Benefit Guide
FlexRx 6-Tier SM Pharmacy Benefit Guide Welcome to FlexRx The AllWays Health Partners FlexRx SM program is built for choice, savings, and convenience with benefits including: Low-cost drug tier for many
More information