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Discussion Draft "FDA Globalization Act of 2008"

Based on inputs from different groups a discussion draft for an "FDA Globalization Act of 2008"  has been released on April 17, 2008.. The goal of this effort is to "provide adequate funding and authority for FDA to ensure the safety the nation's food, drug, medical device and cosmetics supply in an increasingly globalized market place". The draft makes reference to the Federal Food, Drug and Cosmetic Act: Whenever in this act an amendment is expressed in terms of an amendment to a section or other provision, the reference shall be considered to be made to a section or other provision of the Federal Food, Drug and Cosmetic Act" The draft has four sections

  • Food safety
  • Drug and device safety
  • Cosmetic safety
  • Miscellaneous

In this article we will highlight the key points of section 2 and section 4, as it relates to drug and device safety.

For a more detailed discussion you may look at the Labcompliance audio seminar

Title II: Drug and Device Safety.

 

Section 201: Registration Fee to Producers of Drugs and Devices

The Secretary shall assess and collect an annual fee for registration for the purpose of defraying the costs of inspecting establishments registered under such subsection to ensure that such establishments are in compliance The amount of the fee shall be determined by the Secretary.

Section 202: Inspection of Producers of Drugs, Active Pharmaceutical Ingredients, Devices and Device Parts

Domestic and foreign manufacturers of drugs, active pharmaceutical ingredients, class II or III device, should be registered and inspected before delivery products into interstate commerce. A new initial inspection shall be required after modification of products, unless the modification is minor.

Section 203: Documentation of Admissibility of Drug Imports

Drugs shall only enter the United States through a port of entry that is located in a metropolitan area with a federal testing laboratory unless the party offering that drug for import provides the Secretary, at the time of offering the drug for import, documentation demonstrating compliance with applicable requirements pertaining to identity, strength, quality, purity, approval, listing, labeling, and registration. The Secretary may require that such documentation include verification of compliance by an accredited third party or by the Secretary during an inspection within the past two years, and such other information

Section 204: Origin of Ingredients

Drug manufacturers shall provide adequate documentation to establish where
the ingredient was made, including all previous producers and manufacturers, that the ingredient is not adulterated or misbranded, that the ingredient will perform in accordance with specifications, is not contaminated, and does not have any undisclosed additives, and that the ingredient was manufactured, distributed, shipped, warehoused, processed, brokered, imported, and conveyed under conditions that ensure the identity, strength, quality, and purity of the drug

Section 205: Testing for Drug Impurity and Identity

Manufacturer of the finished dosage form, active ingredients, and inactive ingredients contained in or consisting of that drug shall verify that its product’s purity and identity using scientifically sound and appropriate methods of sufficient analytical precision and specificity to detect and quantify the product separate from contaminants, impurities, and adulterants;

Each manufacturer of an active pharmaceutical ingredient contained in or consisting of that drug shall periodically evaluate its ingredient’s impurity profile toverify that it remains substantially similar to or better than the profile of the lot (or lots) used in the clinical  studies and/or toxicological evaluation. If no clinical studies or toxicological evaluation was conducted, then the im1purity profile shall determined according to standards to be established by the Secretary

Section 206: Country of Origin Labeling

Labeling of drugs should identify the country which is the source of active pharmaceutical ingredients in whole or in part, if the information is not available on the website of the manufacturer of the drug.  The labeling of drugs should also include the place manufacture. Labeling of devices should identify the country of manufacture.

Section 207: Recall Authority for Drugs

The Secretary shall have the same recall authority with respect to drugs as the Secretary has with respect to devices. In applying the previous sentence, any reference in such section to a device shall be deemed a reference to a drug.

Section 208: Destruction of Adulterated, Misbranded or Counterfeit Drugs Offered for Import

The Secretary shall have the authority to destroy any product that is refused admission if if (1) it appears to pose a risk of injury or death, or (2) has a value of less than $2,000, as determined by the Secretary’’.

Section 209: Administrative Detention that Appears to Violate the Law

The Secretary shall have the authority for detection of drugs as is currently available for devices. Violation of the law is determined by and officer or employee making an inspection. 

Section 210: Civil Money Penalties for Violative Drugs and Devices and Improper Import Entry Filings

Any person who violates a requirement of this Act that relates to drugs and devices for human use shallbe liable to the United States for a civil penalty not to exceed $100,000 per violation. Each day during which a violation continues shall be considered a separate violation..  Any person, including a manufacturer, distributor, importer, broker, or filer, who knowingly reports or enters false data on documents related to the introduction of drugs and devices in interstate commerce shall be liable to the United States for a civil penalty not to exceed $150,000. Each act of reporting or entering false data shall be considered a separate violation

Title IV: Miscellaneous

 

Section 401: Registration and Fee for Commercial importers of Feed, Drugs, Devices, and Cosmetics

The Secretary shall assess and collect an annual fee for the registration of an importer
of food, drugs, devices, or cosmetics. The amount of the fee shall be $10,000.

Section 402: Unique Identification Number for Food, Drug, and Device Facilities and Establishments

Each Food, Drug, and Device Facility and Establishment Shall get a unique identification number.

Section 403: Dedicated Foreign Inspectorate

The Secretary shall establish and maintain a corps of inspectors dedicated to inspections of foreign vice, and cosmetics facilities and establishments. This corps shall be staffed and funded by the Secretary at a level sufficient to allow it to conduct inspections of foreign food, drug, device and cosmetic facilities and establishments at a frequency at least equivalent to the inspection rate of domestic food, drug, device, and cosmetic facilities and establishments

Section 404: Continued Operation of Field Laboratries

Secretary’’) shall not
(1) terminate any of the 13 field laboratories that were operated by the Office of Regulatory Affairs of the Food and Drug Administration as of 9 January 1, 2007
(2) consolidate any such laboratory with any other laboratory;
(3) terminate any of the 20 district offices or any of the inspection or compliance functions of any of the 20 district offices of the Food and Drug Administration functioning as of January 1, 2007; or
(4) consolidate (A) any such district office with an office, (B) transfer any of the compliance or inspection functions of any such district office to
any other district

 

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