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NaF, Na2SiF6, and H2SiF6 are unapproved drugs. The first step in getting them approved is insuring the quality of drug products by carefully monitoring drug manufacturers' compliance with its Current Good Manufacturing Practice (CGMP) regulations.
Are any fluoridation chemicals/drugs in compliance with ANY part of
Drug Applications and Current Good Manufacturing Practice (CGMP) Regulations
FDA ensures the quality of drug products by carefully monitoring drug manufacturers' compliance with its Current Good Manufacturing Practice (CGMP) regulations. The CGMP regulations for drugs contain minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product. The regulations make sure that a product is safe for use, and that it has the ingredients and strength it claims to have.
The approval process for new drug and generic drug marketing applications includes a review of the manufacturer's compliance with the CGMP. FDA inspectors determine whether the firm has the necessary facilities, equipment, and skills to manufacture the new drug for which it has applied for approval. Decisions regarding compliance with CGMP regulations are based upon inspection of the facilities, sample analyses, and compliance history of the firm. This information is summarized in reports which represent several years of history of the firms.
FDA can issue a warning letter or initiate other regulatory actions against a company that fails to comply with Current Good Manufacturing Practice regulations. Failure to comply can also lead to a decision by FDA not to approve an application to market a drug.
This web page provides links to resources to help drug manufacturers comply with the Current Good Manufacturing Practice regulations.
Code of Federal Regulations (CFR)1. The final regulations published in the Federal Register2 (daily published record of proposed rules, final rules, meeting notices, etc.) are collected in the CFR. The CFR is divided into 50 titles which represent broad areas subject to Federal regulations. The FDA's portion of the CFR interprets the Federal Food, Drug and Cosmetic Act3 and related statutes. Section 21 of the CFR contains most regulations pertaining to food and drugs. The regulations document the actions of drug sponsors that are required under Federal law.
21 Code of Federal Regulations Part 2104. Current Good Manufacturing Practice in Manufacturing Processing, packing, or Holding of Drugs.
21 Code of Federal Regulations Part 2115. Current Good Manufacturing Practice for Finished Pharmaceuticals.
Federal Register Notices for Proposed Changes and Final Changes to CGMP6. The Office of Compliance, Division of Manufacturing and Product Quality web page provides links to in-process changes in CGMP regulations announced in the Federal Register.
Guidance documents represent the Agency's current thinking on a particular subject. These documents are prepared for FDA review staff and drug sponsors to provide guidelines for the processing, content, and evaluation of applications, and for the design, production, manufacturing, and testing of regulated products. They also provide consistency in the Agency's regulation, inspection and enforcement procedures. Because guidances are not regulations or laws, they are not enforceable. An alternative approach may be used if it satisfies the requirements of the applicable statute, regulations, or both.
Guideline on the Preparation of Investigational New Drug Products (Human and Animal) (PDF - 795KB)7 (Issued 11/1992, Posted 3/2/1998). This guidance provides practices and procedures for preparing investigational new drug products that comply with certain section of the Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals (Title 21 of the Code of Federal Regulations, Parts 2108 and 2119.)
Guidance for Industry: Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production (PDF - 98KB)10. 10/2006 This guidance provides the Agency's current thinking on how to evaluate suspect, or out of specification (OOS) test results. For purposes of this document, the term OOS results includes all suspect results that fall outside the specifications or acceptance criteria established in new drug applications.
MaPPs are approved instructions for internal practices and procedures followed by CDER staff to help standardize the new drug review process and other activities. MaPPs define external activities as well. All MaPPs are available for the public to review to get a better understanding of office policies, definitions, staff responsibilities and procedures.
4723.1 Standing Operating Procedures for NDA/ANDA Field Alert Reports (PDF - 15KB)11. 12 (Issued 10/30/1998, posted 11/02/1998). This MaPP establishes a system for evaluating new drug application (NDA) and abbreviated new drug application (ANDA) Field Alert Reports and provides instructions to the responsible CDER units for handling those reports.
Compliance References13. This web site from the Office of Regulatory Affairs provides links to compliance policy guides, regulatory procedures manuals, and other compliance related information. Chapter 4 of the Compliance Policy Guide14 covers human drugs.
Compliance Program Guidance Manual15. These programs and instructions are for FDA field inspectors.
Consistent Application of Current Good Manufacturing Practice Determinations16. FDA cannot approve applications to market new drugs from companies who have been cited for Current Good Manufacturing Practice violations. Similarly, disapproval of any drug marketing application based upon CGMP deficiencies must also lead to regulatory and/or administrative action against other products produced under the same conditions.
--- In FluoridePoisoning@yahoogroups.com, "ron072754" <reheman@...> wrote:
> Are any fluoridation chemicals/drugs in compliance with ANY part of this
> RELEVANT LAW
> The Food. Drug and Cosmetic Act
> 4. Under the FDCA, "label" means a display of written, printed, or
> graphic matter upon the immediate container of any article. 21 U.S.C.
> § 321(k). The term "labeling" is defined as all labels and other
> printed or graphic matter upon any article or any of its containers or
> wrappers, or accompanying such article. 21 U.S.C. § 321(m).
> 5. Under the FDCA, "drugs" are defined as, among other things: (A)
> articles recognized in the official United States Pharmacopeia official
> Homeopathic Pharmacopeia or official National Formulary, or any
> supplement to any of them; (B) articles intended for use in the
> diagnosis, cure, mitigation, treatment, or prevention of disease in man
> or other animals; (C) articles (other than food) intended to affect the
> structure or any function of the body of man or other animals; and (0)
> articles intended for use as a component of any articles specified in
> clause (A), (B), or (C). 21 U.S.C. § 321(g).
> 6. A "new drug" is any drug which is not generally recognized, among
> experts qualified by scientific training and experience to evaluate the
> safety and effectiveness of drugs, as safe and effective for use under
> the conditions prescribed, recommended, or suggested in the labeling
> thereof. 21 U.S.C. § 321(P)(1). In order to be lawfully marketed,
> sold or dispensed in the United States, a new drug had to be the subject
> of a New Drug Application (''NDA'') which had been approved by the FDA.
> 21 U.S.C. § 355.
> 7. A drug intended for use in man which, because of its toxicity, or
> other potentiality for harmful effect. or the method of its use, or the
> collateral measures necessary to its use, is not safe for use except
> under the supervision of a practitioner licensed by law to administer
> such drug; or a drug which is limited by an approved application under
> 21 U.S.C. § 355 to use under the professional supervision of a
> practitioner licensed by law to administer such drug, can only be
> dispensed by a practitioner licensed by law pursuant to a lawful
> prescription. 21 U.S.C. § 353(b)(I). These drugs are commonly known
> as "prescription drugs." Dispensing a prescription drug without a valid
> prescription by a licensed practitioner is deemed by statute to be an
> act which causes the drug to be "misbranded" while held for sale. 21
> U.S.C. § 353(b).
> 8. Under the FDCA, every person engaging in the manufacture,
> preparation, compounding, or processing of drugs in any establishment
> which he or she owns or operates, is required to immediately register
> his or her name, places of business, and all such establishments. 21
> U.S.C. § 360(c). The terms "manufacture, preparation, propagation,
> compounding, or processing" include repackaging or otherwise changing
> the container, wrapper, or labeling of any drug in furtherance of the
> distribution of the drug from the original place of manufacture to the
> person who makes the final sale to the ultimate consumer or user. 21
> U.S.C. § 360(a)(1).
> 9. A drug is misbranded if, among other things, its labeling is false or
> misleading in any particular. 21 U.S.C. § 352(a). A drug is also
> misbranded if the labeling on the drug does not bear adequate directions
> for use. 21 U.S.C. § 352(1)(1). "Adequate directions for use" means
> directions under which a layman can use a drug safely and for the
> purposes for which it was intended without a doctors supervision. 21
> C.F.R. § 201.5. This regulation goes on to state: "Directions for use
> may be inadequate because .... of omission, in whole or in part, or
> incorrect specification of: (a) Statements of all conditions, purposes,
> or uses for which such drug is intended, including conditions, purposes,
> or uses for which it is prescribed, recommended, or suggested in its
> oral, written, printed, or graphic advertising, and conditions,
> purposes, or uses for which the drug is commonly used."
> 10. Directions under which a layperson can use a drug safely cannot be
> written for a prescription drug because such drugs can, by definition,
> only be used safely (if at all) at the direction, and under the
> supervision, of a licensed practitioner. Approved prescription drugs
> dispensed pursuant to a valid prescription are exempt from having
> adequate directions for use by a layperson. But prescription drugs that
> are unapproved new drugs or dispensed without a valid prescription are
> necessarily misbranded for lacking adequate directions for use.
> 11. Dispensing a prescription drug without a valid prescription by a
> licensed practitioner is deemed by statute to be an act which results in
> the drug being misbranded while held for sale. 21 U.S.C. § 353(b)(1).
> 12. Under the FDCA, the doing or causing of the following acts, among
> others, is prohibited:
> a. The introduction or delivery for introduction into interstate
> commerce of any drug that is misbranded (21 U.S.C. § 331(a». b.
> The receipt in interstate commerce of any drug that is misbranded, and
> the delivery or proffered delivery thereof for pay or otherwise (21
> U.S.C. § 33 1 (c». c. The introduction or delivery for
> introduction into interstate commerce of an unapproved new drug (21
> U.S.C. § 331(d». d. The doing of any act with respect to a drug,
> if such act is done while the drug is held for sale (whether or not the
> first sale) after shipment in interstate commerce. which results in the
> drug being misbranded (21 U.S.C. § 331(k».
> --- In FluoridePoisoning@yahoogroups.com, "ron072754" reheman@
> > Fluoridation started in 1945 in Grand Rapids Michigan. The very first
> > drop was illegal and millions of gallons later nothing has changed.
> > Na2SiF6, and H2SiF6 have never been approved by the FDA for internal
> > ingestion intended for use in the diagnosis, cure, mitigation,
> > treatment, or prevention of disease in man or other animals; and
> > intended to affect the structure or any function of the body of man or
> > other animals. Furthermore, all fluoride vitamins, drops and pills
> > fall into this catagory.
> > The entire chain, from the manufacturer, shippers, middlemen,
> > distributers, pharmacies, doctors, dentists, cities, mayors, city
> > boards, commissioners private and public water distributers and all
> > personal, and the National Sanitation Foundation are liable for
> > charges and direct action by the Food and Drug Administration at any
> > time.
> > Why has the FDA failed to act on the issue of unapproved fluoridation
> > drugs? The FDA is ignoring the law. FDA's actions are contrary to law,
> > arbitrary, capricious and an abuse of discretion. The plain language
> > the law says an article that appears to be misbranded or unapproved
> > shall be in violation. The FDA should notify immediately anyone in
> > possession of foreign or demostic-manufactured fluoridation
> > chemicals/drugs that its use is prohibited by law and that the drug
> > be returned to the FDA. The U.S. Drug Enforcement Administration
> > seize supplies because they are illegal or because of questions over
> > they were manufactured. The FDA is undermining its own policy of
> > maintaining a closed drug distribution system designed to keep
> > drugs out of U.S. Commerce. Opening up the 'closed' drug system by
> > allowing an unapproved drug, the FDA is jeopardizing their own system
> > and threatens the public health by creating a risk that could cause
> > the general public.
> > The FDA has long taken the position that consumers are exposed to a
> > number of risks when they are exposed to unapproved drugs because,they
> > may be expired, subpotent, contaminated or counterfeit product, the
> > wrong or a contraindicated product, an incorrect dose, or medication
> > unaccompanied by adequate directions for use.
> > The FDA's decision not to act on enforcing the removal of unapproved
> > drugs or to initiate enforcement proceedings against a violator is a
> > decision to ignore an administrative directive.