4/26/2013. Libia Lugo Drug Specialist San Juan District Office Investigations Branch

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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

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