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What is the FDA's Code of Federal Regulations at Title 21, Section 216.24?

Posted By Administration, Friday, October 7, 2016

§216.24   Drug products withdrawn or removed from the market for reasons of safety or effectiveness.

The following drug products were withdrawn or removed from the market because such drug products or components of such drug products were found to be unsafe or not effective. The following drug products may not be compounded under the exemptions provided by section 503A(a) of the Federal Food, Drug, and Cosmetic Act:

Adenosine phosphate: All drug products containing adenosine phosphate.

Adrenal cortex: All drug products containing adrenal cortex.

Azaribine: All drug products containing azaribine.

Benoxaprofen: All drug products containing benoxaprofen.

Bithionol: All drug products containing bithionol.

Bromfenac sodium: All drug products containing bromfenac sodium.

Butamben: All parenteral drug products containing butamben.

Camphorated oil: All drug products containing camphorated oil.

Carbetapentane citrate: All oral gel drug products containing carbetapentane citrate.

Casein, iodinated: All drug products containing iodinated casein.

Chlorhexidine gluconate: All tinctures of chlorhexidine gluconate formulated for use as a patient preoperative skin preparation.

Chlormadinone acetate: All drug products containing chlormadinone acetate.

Chloroform: All drug products containing chloroform.

Cobalt: All drug products containing cobalt salts (except radioactive forms of cobalt and its salts and cobalamin and its derivatives).

Dexfenfluramine hydrochloride: All drug products containing dexfenfluramine hydrochloride.

Diamthazole dihydrochloride: All drug products containing diamthazole dihydrochloride.

Dibromsalan: All drug products containing dibromsalan.

Diethylstilbestrol: All oral and parenteral drug products containing 25 milligrams or more of diethylstilbestrol per unit dose.

Dihydrostreptomycin sulfate: All drug products containing dihydrostreptomycin sulfate.

Dipyrone: All drug products containing dipyrone.

Encainide hydrochloride: All drug products containing encainide hydrochloride.

Fenfluramine hydrochloride: All drug products containing fenfluramine hydrochloride.

Flosequinan: All drug products containing flosequinan.

Gelatin: All intravenous drug products containing gelatin.

Glycerol, iodinated: All drug products containing iodinated glycerol.

Gonadotropin, chorionic: All drug products containing chorionic gonadotropins of animal origin.

Mepazine: All drug products containing mepazine hydrochloride or mepazine acetate.

Metabromsalan: All drug products containing metabromsalan.

Methamphetamine hydrochloride: All parenteral drug products containing methamphetamine hydrochloride.

Methapyrilene: All drug products containing methapyrilene.

Methopholine: All drug products containing methopholine.

Mibefradil dihydrochloride: All drug products containing mibefradil dihydrochloride.

Nitrofurazone: All drug products containing nitrofurazone (except topical drug products formulated for dermatalogic application).

Nomifensine maleate: All drug products containing nomifensine maleate.

Oxyphenisatin: All drug products containing oxyphenisatin.

Oxyphenisatin acetate: All drug products containing oxyphenisatin acetate.

Phenacetin: All drug products containing phenacetin.

Phenformin hydrochloride: All drug products containing phenformin hydrochloride.

Pipamazine: All drug products containing pipamazine.

Potassium arsenite: All drug products containing potassium arsenite.

Potassium chloride: All solid oral dosage form drug products containing potassium chloride that supply 100 milligrams or more of potassium per dosage unit (except for controlled-release dosage forms and those products formulated for preparation of solution prior to ingestion).

Povidone: All intravenous drug products containing povidone.

Reserpine: All oral dosage form drug products containing more than 1 milligram of reserpine.

Sparteine sulfate: All drug products containing sparteine sulfate.

Sulfadimethoxine: All drug products containing sulfadimethoxine.

Sulfathiazole: All drug products containing sulfathiazole (except those formulated for vaginal use).

Suprofen: All drug products containing suprofen (except ophthalmic solutions).

Sweet spirits of nitre: All drug products containing sweet spirits of nitre.

Temafloxacin hydrochloride: All drug products containing temafloxacin.

Terfenadine: All drug products containing terfenadine.

3,3′,4′,5-tetrachlorosalicylanilide: All drug products containing 3,3′,4′,5-tetrachlorosalicylanilide.

Tetracycline: All liquid oral drug products formulated for pediatric use containing tetracycline in a concentration greater than 25 milligrams/milliliter.

Ticrynafen: All drug products containing ticrynafen.

Tribromsalan: All drug products containing tribromsalan.

Trichloroethane: All aerosol drug products intended for inhalation containing trichloroethane.

Urethane: All drug products containing urethane.

Vinyl chloride: All aerosol drug products containing vinyl chloride.

Zirconium: All aerosol drug products containing zirconium.

Zomepirac sodium: All drug products containing zomepirac sodium.

Tags:  chelation  chelation therapy  compounding  FDA 

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FDA: Additions/modifications to the list of drug products that have been withdrawn or removed from the market for reasons of safety or effectiveness

Posted By Administration, Thursday, October 6, 2016
Updated: Friday, October 7, 2016

Today, the U.S. Food and Drug Administration issued a final rule amending FDA’s list of drug products that may not be compounded under certain sections of the Food, Drug, and Cosmetic Act (FD&C Act) that allow the marketing of unapproved compounded drugs.

Drug products on the list may not be compounded because the drug products have been withdrawn or removed from the market for safety or effectiveness reasons. The list appears in the Code of Federal Regulations at Title 21, section 216.24.

The final rule:

  • Adds 24 types of drugs to the withdrawn or removed list.
  • Modifies the withdrawn or removed list to allow one type of drug product to be compounded under certain circumstances.
  • Clarifies that the withdrawn or removed list applies to sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act.

In addition, FDA published a discussion in the Federal Register that clarifies the procedure FDA intends to use to amend the withdrawn or removed list.

FDA’s website has additional information on compounding.

Tags:  chelation  chelation therapy  Code of Federal Regulations at Title 21  compounding  fda  fda compounding  section 216.24 

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TAKE ACTION NOW: FDA "Compounds" Its Attack on Supplements

Posted By Administration, Monday, July 13, 2015

The FDA’s hostility toward both supplements and compounded medicine is legendary—after all, they compete with the FDA-approved drugs that pay the government’s bills. Now the agency is attacking compounded supplements. Action Alert!

A few weeks ago, we reported on an amendment designed to fix a number of the most problematic regulations arising from Congress’s Drug Quality and Security Act (DQSA). The amendment would clarify provisions governing “office use,” allowing physicians to keep certain quantities of compounded drugs on hand in their office, and also remove the cap on interstate shipments if the medication is for an individual patient. ANH-USA strongly supports this amendment, as it would ensure patient access to important compounded medications which are currently endangered.


READ COMPLETE ARTICLE AND TAKE ACTION

Tags:  action amendment  compounds  FDA  House appropriations committee  supplements 

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AHPA Testimony Outlines Adequacy of Current FDA Framework for Homeopathic Drug Regulation

Posted By Reprinted with permission from Natural Practitioner Magazine, Friday, June 5, 2015
Updated: Wednesday, June 3, 2015
The Food and Drug Administration's (FDA) current regulation of homeopathic drugs provides sufficient, substantial oversight of these products, according to testimony presented by the American Herbal Product Association (AHPA) at a public hearing held by FDA on April 20-21. The hearing, "Homeopathic Product Regulation: Evaluating FDA's Regulatory Framework After a Quarter-Century," was held to gather input on appropriate regulatory policy for homeopathic medicines.

AHPA's testimony, presented by Will Woodlee, partner at Kleinfeld, Kaplan and Becker, LLP, highlighted several points that demonstrate the adequacy of FDA's current regulatory framework for homeopathic medicines in protecting public health and ensuring consumer access to safe products.

Woodlee stressed that, under the existing framework, companies are required to register their facilities and to list their drug products with FDA, which, along with other investigative and surveillance tools, provides the agency with the means to identify manufacturers, marketers, and products as candidates for education, administrative action, or enforcement action, as necessary or appropriate.

The current regulatory framework also provides FDA with sufficient information on adverse events associated with over-the-counter (OTC) homeopathic drug products to allow the agency to protect the public health, according the AHPA's testimony. Manufacturers are required to maintain records of all adverse events reported to them and must maintain records and reports regarding complaints. When required, firms must investigate these complaints and, upon request, make their files available during FDA inspections.

Woodlee also noted that FDA's existing regulatory framework for homeopathic drug products appropriately reflects the small saety risk inherent to these highly diluted products. In addition, AHPA is not aware of any data indicating that consumers perceive appropriately marketed OTC homeopathic drug products as substitutes for prescription drugs, and AAHPA believes FDA currently has adequate enforcement authority to address and OTC homeopathic drug products that inappropriately marketed for non-OTC indications or without adequate directions for use.

For m ore information, visit www.ahpa.org or www.fda.gov.

Tags:  AHPA  FDA  homeopathic  homeopathic drug regulation 

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GNC Makes Deal with NY Attorney General

Posted By Reprinted with permission from Vitamin Retailer, Friday, May 15, 2015
On March 30, GNC (Pittsburgh, PA) announced that it had reached an agreement with the New York Attorney General (NYAG) that affirms the company's Herbal Plus products were in full compliance with the federal U.S. Food and Drug Administration (FDA) current good manufacturing practice (cGMP) requirements and acknowledges GNC's full cooperation with the AG's inquiries.

In its response to the NYAG's inquiry, GNC provided the results of rigorous tests conducted both internally and by independent third parties. These tests provided conclusive evidence that GNC's products are safe, pure, properly labeled and in full compliance with all regulatory requirements. The testing also demonstrated that the company's products contain all herbal extracts listed on their respective labels.

In addition, a former senior FDA cGMP expert performed a comprehensive review of GNC's manufacturing processes for the products at issue and found them to be in compliance with all applicable requirements. Accordingly, GNC has restored its full assortment of Herbal Plus products to all GNC stores in New York State.

GNC also announced that it will expand its testing processes deeper into its supply chain by leading ongoing industry efforts to integrate source material traceability standards including DNA barcoding where appropriate(prior to extraction processes) and enhance certain other aspects of its operations to provide consumers even greater confidence in its products.

GNC said that it believe these measures, which would not have impacted availability of the products subject to this review, will result in the adoption of stricter minimum standards across the broader industry.
"As our testing demonstrated, and this agreement affirms beyond any doubt, our products are not only safe and pure but are in full copliance with all regulatory rewquirements," said Michael G. Archbold, CEO, GNC. "A robust testing regime, careful sourcing regimen and detailed manufacturing specifications have always been cor elements to ensuring that we provide our customers with high-quality products. Our customers trust and value our products, and we are steadfastly committed to maintaining that trust and confidence. As an industry leader we have always gone above and beyond the minim requirements in pursuing quality for our consumers, and we will continue to lead the efforts for higher standards. This is good for consumers, good for the industry and good for GNC.

GNC has preserved the specific product lots of the five products that were the subject of the NYAG inquiry for us in defending the Company against the lawsuits that have been filed subsequent to the NYAG's February 2 letter, despite the fact that there is no prohibition against the sale of such products. GNC believes these lawsuits are completely without merit and will defend itself aggressively. Identical products to those that have been preserved remain available for sale to consumers at GNC stores in New York State. For more information, visit www.gnc.com.

Tags:  dietary supplements  FDA  GNC  Target  Walgreens  Walmart 

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Guest Editorial: The Beat Goes On

Posted By Daniel Breeman, Editor-in-Chief, Natural Practitioner Magazine, Friday, May 15, 2015

Just how much longer will the dietary supplement industry continue to be under attack? And more importantly, has the damage already been done?

It's been nearly three months since New York Attorney General Eric Schneiderman launched his investigation into the dietary supplements industry by issuing cease-and-desist letters to four major retailers - GNC, Target, Walgreens and Walmart - calling on them to pull their own brands of herbal supplements from their shelves, following an investigation by his office that found nearly 80 percent of the products tested from those stores contained none of the plants listed on the products' labels. GNC, as you may know, reached an agreement with the attorney general's office in late March whereby the company will use DNA tests to authenticate the plants that will be used as ingredients in its herbal supplements. Some industry experts applauded the agreement, while others said it set a dangerous precedent going forward.

Of course, the questionable DNA testing methods used have come under hard scrutiny by the likes of the Natural Products Association (NPA), the Council for Responsible Nutrition (CRN) and other industry groups, but that didn't prevent Schnedierman and 13 other state attorneys general from sending a letter to Congress requesting an investigation into herbal supplements and calling for more regulatory oversight of the industry by the Food and Drug Administration (FDA). Schneiderman and his counterparts, despite admitting that the federal good manufacturing practices currently in place for dietary supplements are sufficient, continues to push forward in what is seemingly becoming a "witch hunt" at the expense of taxpayer dollars.

While the two sides continue to slug it out and the NPA calling for a grassroots campaign to attempt to prevent Schneiderman from taking further action, a larger question for the industry at-large may be, "Has the damage already been done?" While little has yet to be determined legally regarding the outcome of the dispute, the danger here for the dietary supplement industry is that in the court of public opinion, they may have already lost.

Of course, a Harvard-led study early last month that indicated that a handful of weight-loss and sports supplements contained amphetamine-like ingredients, not the plant extract listed on the label of the product, didn't help the cause.

For those who have long supported the dietary supplement industry, not much will change. Natural products manufacturers, suppliers and retailers alike will strongly defend the methods used to test and regulate their industry and will continue to fight for its survival. On the other hand, those who have long opposed or questioned the industry now have more ammunition at their disposal to challenge every move the industry makes. And finally, the real danger here is in convincing those consumers who have long been considering walking into your store to try a natural remedy or supplement might now be turned off by the ongoing negative press.

So what's the next step? Will the letter to Congress sent by Schneiderman and the 13 other state attorneys general be enough to eventually push the industry under regulation by the federal government? Does DSHEA carry no weight here?

For now, the smart move for the dietary supplement industry is to continue to provide the quality products that it's always provided. I also encourage you to take part in NPA's grassroots campaign and to join in fighting the good fight.

Tags:  dietary supplements  DNA testing methods  FDA  GNC  Target  Walgreens  Walmart 

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