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FDA: Additions/modifications to the list of drug products that have been withdrawn or removed from the market for reasons of safety or effectiveness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Drug products on the list may not be compounded because the drug products have been withdrawn or removed from the market for safety or effectiveness reasons.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  • Adds 24 types of drugs to the withdrawn or removed list.
  • Modifies the withdrawn or removed list to allow one type of drug product to be compounded under certain circumstances.
  • Clarifies that the withdrawn or removed list applies to sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act.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FDA published a discussion in the Federal Register that clarifies the procedure FDA intends to use to amend the withdrawn or removed list.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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Threats to Compounded Medicine and What You Can Do

Posted By ANH - Alliance for Natural Health USA, Friday, June 3, 2016

In 2013, Congress passed the Drug Quality and Security Act (DQSA), which tightened federal control over compounding pharmacies.
To implement the law, the FDA is setting guidelines for what can be compounded at “traditional” pharmacies (503A facilities) and outsourcing pharmacies (503B facilities).

In general:

·        503B facilities will only be able to compound drugs that appear on a separate pre-approved list, which has not yet been finalized. Current thinking is that this list will be extremely limited in terms of the needs of integrative physicians. 

·        503A pharmacies are also facing harsh restrictions. DQSA rules limit the substances that can be compounded by traditional pharmacies to those that either 1) have US Pharmacopoeia monographs, 2) are components of approved drugs, or 3) appear on a pre-approved list by the FDA. The FDA is developing a separate “Demonstrably Difficult to Compound List” that will exclude many other important ingredients from compounding.

What is threatened?
Bioidentical Hormones
—Estriol, progesterone, testosterone, and other hormones have been nominated to the “Demonstrably Difficult to Compound” list, meaning that access to compounded hormones is in grave danger.
Supplements—Although many supplements have USP monographs, the FDA has stated that supplements must be pre-approved to be legally compounded. Many supplements and natural ingredients that have been nominated have been rejected, such as curcumin, aloe vera, boswellia, and acetyl-L-carnitine, to name just a few.
IV Nutrients—It is unclear whether the FDA will allow the compounding of nutrient IV bags—especially due to the threats to compounded supplements.
Office Use— The FDA has made it illegal for doctors to keep compounded medications from 503A facilities in their offices without a prescription, a practice known as “office use.” This has increased the cost of these medications, not to mention the added hassle for patients. Medications without prescriptions from 503B facilities can continue, but the list of medications that can be legally compounded by 503B facilities will be limited.
Affordability—Due to the above-mentioned restrictions, and the threat of more to come, it has become extremely difficult for doctors to obtain medications. For example, the price of injectable B-12 has climbed just under 700% from the mid-2000’s.
Interstate Commerce—DQSA limits the amount of interstate shipments that 503A facilities can make to 5% of total sales. This is extremely problematic given that certain pharmacies specialize in specific preparations. A memorandum of understanding released by the FDA increases this amount to 30%, but then states must take over regulatory responsibility over these facilities. Since it is likely that many states will not elect to take on this additional burden, the upshot is 503A facilities will only be able to ship a small portion of their medications out of state, which could create shortages and increase the price of compounded medications further. 

What Can You Do?

·        Follow the developments regarding compounding at ANH-USA.org. 

·        Participate in ANH-USA action alerts that urge lawmakers and regulators to preserve access to compounded medications.

·        Share your story with ANH-USA at http://www.anh-usa.org/contact-anh-usa/

·        Support ANH-USA in its efforts to rein in these excessive, burdensome, and costly regulations at http://www.anh-usa.org/donate/

Tags:  chelation  compounding pharmacy  FDA compounding 

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Chelation Therapy: What You Need to Know

Posted By ANH: Alliance for Natural Health USA, Friday, June 3, 2016

Chelation therapy has been receiving a lot of attention lately for the accumulating evidence of its effectiveness in treating patients—but also from regulators whose recent actions threaten to eliminate access to important chelation drugs.

Is chelation safe?
Despite concerns voiced by regulators, recent evidence has shown that intravenous therapy with edetate disodium (EDTA) to treat cardiovascular disease is safe. In a study of the NIH-sponsored Trial to Assess Chelation Therapy (TACT), Dr. Jeanne Drisko and co-authors concluded, “The experience with 55,222 infusions of edetate disodium or placebo in TACT shows that this therapy is safe when used according to the TACT safe infusion protocol.”[1]


What are the threats to future access?
Recent events show a number of reasons to be concerned about continuing access to chelation therapy in your practice.


FDA compounding rules.
In 2013, Congress passed the Drug Quality and Security Act which tightened federal control over compounding pharmacies. This law set guidelines for what can be compounded at “traditional” pharmacies (503A facilities) and outsourcing pharmacies (503B facilities). Among other things, these rules limit the substances that can be compounded by traditional pharmacies to those that either 1) have US Pharmacopoeia monographs, 2) are components of approved drugs, or 3) appear on a pre-approved list by the FDA. 503B facilities will only be able to compound drugs that appear on a separate pre-approved list, which has not yet been finalized.


Recent meetings strongly suggest that many natural substances and substances used by integrative doctors are being rejected for inclusion on the FDA’s pre-approved list for 503A pharmacies, meaning they will be illegal to compound. An FDA advisory committee has already rejected curcumin, aloe vera, boswellia, and acetyl-L-carnitine, to name just a few.

This means it is extremely unlikely that doctors and patients will continue to have access to:

·        Compounded chelation drugs such as dimercaptosuccinic acid (DMSA)

·        DMPS (sodium 2,3-dimercaptopropane-1-sulfonate)

·        Compounded IV nutrients

·        Compounded supplements (even though many supplements have monographs, the FDA has said supplements must be pre-approved to be legally compounded)

Recent regulations have also made it illegal for doctors to keep compounded medications from 503A facilities in their offices without a prescription, a practice known as “office use.” This has increased the cost of these medications, not to mention the added hassle for patients. Medications without prescriptions from 503B facilities can continue, but the list of medications that can be legally compounded by 503B facilities will be limited.

EDTA on the chopping block?
In response to patient deaths allegedly linked to chelation therapy, the FDA is reviewing the “benefit/risk profile of [EDTA] to determine if the benefits of its intended use continue to outweigh the serious risks.”[1] Given the agency’s antipathy towards integrative medicine, it is likely to take action against EDTA.


State Medical Board Hostility.
State medical boards have been historically aggressive against doctors using chelation therapy—totaling 194 actions over 40 years. Mostly these actions have been against doctors using chelation without proving heavy metal toxicity with a blood—even though blood tests are not a reliable measure for heavy metal toxicity, since metals circulate in blood for a short time before concentrating in tissue.

Medical boards in Tennessee, New Hampshire, and Oregon have taken official positions on chelation that threaten action against doctors using chelation beyond FDA-approved uses.[2]

What can you do?

·        Follow the developments regarding chelation therapy at ANH-USA.org. 

·        Participate in ANH-USA action alerts that urge lawmakers and regulators to preserve access to chelation therapy.

·        Share your story with ANH-USA at http://www.anh-usa.org/contact-anh-usa/

 


[1] Poster: Post-myocardial Infarction Treatment with Edetate Disodium Was Safe in the Trial to Assess Chelation Therapy (TACT) - Jeanne A. Drisko MD, Karen P. Alexander MD, Rhonda S. Roberts MSPH, L. Terry Chappell, MD, Kerry L. Lee PhD, Robin Boineau MD, Daniel B. Mark MD, Richard L. Nahin PhD, Christine Goertz DC PhD, Yves Rosenberg MD, Gervasio A. Lamas MD. TACT chelation infusion: disodium EDTA, 3 grams, adjusted downward baed on eGFRl ascorbic acid, 7 grams; magnesium chloride, 2 grams; potassium chloride, 2 mEq; sodium bicarbonate, 840 mg; pantothenic acid, thiamine, pyridoxine; procaine, 100 mg; unfractionated heparin, 2500 U; sterile water to 500 mL

[2]http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm113736.htm

[3] See, for example, this notice from the Tennessee Board of Medical Examiners: https://www.tn.gov/assets/entities/health/attachments/g4015060.pdf

 

INTERESTED IN CERTIFICATION IN CHELATION THERAPY?
Visit www.acam.org/CAP to learn about ACAM's exclusive Chelation Advanced Provider Training

Tags:  alliance for natural health  chelation therapy  edetate disodium  EDTA  FDA compounding  TACT  Tact2 

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