For the past 35 years the FDA has neglected to bring meaningful treatments to market for people with Myalgic Encephalomyelitis / Chronic Fatigue Syndrome (ME/CFS). The lack of FDA-approved drugs means many patients rely on compounded medications to help improve symptoms and quality of life.
The FDA is considering banning substances that have helped people with ME/CFS gain significant functionality, and substances that may help people with ME/CFS before they’ve even had a chance to try them.
The FDA is in the process of reviewing bulk substances used in IV therapies, injections, and oral compounds to determine whether or not they will remain legal or be banned from being used in compounding. (This process does NOT affect commercial supplement manufacturers – only compounded products.)
Even though oral or commercial versions of these substances are available, many of us are allergic to common fillers and require a clean, compounded version, or require a special dosage or format (to get them directly into our bloodstream, for example, in a case where our intestines are not able to absorb them).
The concern is that the FDA is not considering the needs of people with ME/CFS when it decides which compounded medications to ban. Many of the compounded substances on the banned list have been used successfully in ME/CFS patients. The voice of ME/CFS patient has been further drowned out by the disbanding of the Chronic Fatigue Syndrome Advisory Committee this past summer.
The International Association of Compounding Pharmacists (IACP), states, “In certain areas, we believe the FDA is overstepping the regulatory authority given to the agency by Congress in the Federal Food, Drug, and Cosmetic Act as amended by the DQSA and infringing upon the role of state board of pharmacy in the regulation of the practice of pharmacy.”
As patients who greatly benefit from compounded medications we must demand that our access to these medications be protected. It is critical that we voice our concerns with the FDA before we are left without any options at all for treatment.
The FDA has not disclosed when the ban will take effect. Stakeholders speculate it could be as early as January 2019 or take up to three years.
This process does NOT apply to any FDA approved substances with a USP-NF monograph. (See notes below.)
- The Pharmacy Compounding Advisory Committee is reviewing substances in groups of ten. Below are lists of substances for compounding that have been approved, banned or are awaiting hearing.
- If you see substances on these lists that are important to you as compounded drugs, contact the Pharmacy Compounding Advisory Committee to let them to know not to ban them! (Scroll down for instructions.) They need to hear from people with ME and mast cell activation syndrome otherwise they won’t take our needs into consideration.
Awaiting hearing – The Federal Register will announce when these substances will be reviewed by the committee:
- ornithine hydrocholoride
- ox bile extract
Legal – The committee voted to approve these substances for compounding:
- alpha lipoic acid (oral only, no IV or injectable)
- coenzyme Q10 (oral only, no IV or injectable)
- creatine monohydrate (oral only, no IV or injectable)
- pyridoxal 5 phosphate (IV and oral)
Illegal – The committee voted to ban these substances for compounding:
- nicotinamide adenine dinucleotide (NAD)
- nicotinamide adenine dinucleotide disodium (NADH)
- quercetin dihydrate
- vasoactive intestinal peptide (VIP)
The committee has judged these substances not worthy of a hearing and they will automatically become illegal to compound:
- dichloroacetic acid (DCA)
- gamma aminobutyric acid (GABA)
- magnesium bisglycinate and glycinate
- manganese bisglycinate
- molybdenum glycinate
- ornithine hydrocholoride
- ox bile extract
- zinc picolinate and citrate
Contact the FDA about your Compounded Drugs
Please write the FDA a short note/email for each substance:
Subject:“503b Compounding – Substance Name”
Email: Explain that you have Myalgic Encephalomyelitis/Chronic Fatigue Syndrome and are using this substance with a doctor’s prescription, why it was prescribed, and the benefits you are getting from it. If you want to, include links to any supporting research – the FDA is swayed by facts.
Send it to:
Mail: Cindy Chee, PharmD, Designated Federal Officer (DFO)
Division of Advisory Committee and Consultant Management
Office of Executive Programs
Center for Drug Evaluation and Research
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, Maryland 20993-0002
Phone: (301) 796-9001
Fax: (301) 847-8533
Why the FDA is reviewing compounded drugs
In 2013, Congress passed the Drug Quality and Security Act (DQSA) in response to a fungal meningitis outbreak in 2012. This outbreak was due to contaminated compounds prepared under inappropriate conditions and resulted in 64 deaths across 20 states. Existing laws were used to send the makers of these contaminated injections to prison. This public health tragedy is not one to be ignored or forgotten and the goal of DQSA and compounding pharmacies should strive to ensure both patient safety and access.
FDA Commissioner, Dr. Scott Gottlieb, states, “Because compounded drugs are not FDA-approved and do not undergo premarket review by the FDA for safety, effectiveness and quality; they also present a greater risk to patients than FDA-approved drugs.” Gottlieb believes this was demonstrated by the fungal meningitis outbreak. However, an extensive list of FDA approved drug tragedies have seemingly been ignored when defending DQSA. For example:
- In 2001 Baycol® (cerivastatin), was found to be responsible for over 100,000 deaths and more than $1.2 billion in litigation damages.
- In 2004, Vioxx® (rofecoxib) was recalled for increased risk of heart attacks and stroke. Both the manufacturer of Vioxx® and the FDA were aware of the increased risks yet the drug reached consumers. Up to 140,000 people could have suffered heart attacks and stroke by taking the drug.
- In 1998, Posicor® (mibefradil) was recalled for being linked to 123 deaths due to potential deadly drug-drug interactions.
These are just a few examples of so called “safe FDA approved drug” tragedies. Many other medications over the years that have been pulled off the market due to potential risks and deaths caused by the drugs we are led to believe are safer than compounded medications.
Gottlieb also states, “We’re fully committed to implementing the DQSA requirements in a way that preserves access to compounded drugs for patients who have medical need for them, while protecting patients from poor quality or otherwise unsafe compounded drugs that could cause them serious harm.”
However, there is deep concern that the needs of people with ME/CFS are not being considered in this review process.
This process does NOT apply to any FDA approved substance with a USP-NF monograph.
- B12: Cyano and Hydroxo forms are FDA/USP approved drugs. Methyl B-12 is not approved, it is awaiting hearing.
- Amino Acids: Mixed amino acids like FreeAmine, Aminosyn etc. are FDA-USP approved drugs (although they contain other ingredients which patients might be allergic to). Some single amino acids are approved in one form and not another (i.e. l-cysteine is as is NAC)
- Calcium: Calcium Gluconate and Chloride are FDA-USP approved drugs.
- Magnesium: Chloride and Sulfate forms are FDA-USP approved, but Magnesium ascorbate, Magnesium bisglycinate, Magnesium bisglycinate dehydrate, Magnesium glycinate are not.
- B5: Dexpanthenol injection is FDA-USP approved BUT Pantothenic acid is not.
- B6: Pyridoxine is FDA-USP approved.
- Selenium: Selenium injection is FDA-USP approved.