The FDA states that compounded drugs are not FDA-approved, which means FDA does not verify the safety, effectiveness or quality of compounded drugs before they are marketed. A Drugs@FDA record shows that an approved cyanocobalamin injection also exists. No source used here analyzes the content or sterility of any compounded B12 product.
What the FDA says compounded drugs are and are not
A second FDA page, Understanding the Risks of Compounded Drugs, states that compounded drugs are not FDA-approved, which means the agency does not review their safety, effectiveness or quality before they are marketed. The Q&A page states that compounded drugs should only be used in patients whose medical needs cannot be met by an FDA-approved drug, and that unnecessary use may expose patients to potentially serious health risks. It also states that poor compounding practices can result in serious drug quality problems, such as contamination or a drug that contains too much or too little active ingredient, which can lead to serious patient injury and death.
Section 503A, outsourcing facilities, labels and online purchase
| Question | What the source says |
|---|---|
| What is section 503A? | The FDA states that section 503A describes the conditions under which compounded human drug products are exempt from the FD&C Act sections on FDA approval prior to marketing, current good manufacturing practice (CGMP) requirements, and labeling with adequate directions for use. |
| How do outsourcing facilities differ? | The FDA states that outsourcing facilities are subject to CGMP requirements, unlike compounders operating under section 503A, and may distribute compounded drugs either pursuant to a patient-specific prescription or in response to an order from a health care provider. It also states that quality standards for compounded drugs differ depending on the setting where compounding occurs. |
| What does it say about labels? | The FDA states that labels on compounded drugs may not include important information such as adequate directions to help ensure the drugs are used safely. Its risk alerts page lists an alert that differences in strength expression on product labels of compounders and conventional manufacturers may lead to dosing errors. |
| What does it say about buying online? | The FDA states that consumers who purchase compounded drugs online, such as through online pharmacies and telehealth platforms, may not know the identity of the compounder that produced the drug, including whether it was produced by a compounder whose drugs meet appropriate quality standards. |
Outbreaks and one sample analysis
The FDA states that in 2012, contaminated drugs compounded by a Massachusetts pharmacy led to more than 750 cases of infection and more than 60 deaths of patients in 20 states. A review of infection outbreaks linked to contaminated pharmacy-compounded sterile preparations identified 19 outbreaks, resulting in at least 1000 cases, including deaths.
A PubMed abstract on compounded polidocanol injection, a different drug from cyanocobalamin, reports that seven samples from three compounding pharmacies were analyzed, none contained the labeled concentration and five contained excessive levels of impurities. This is an observational analysis of those samples. It cannot show cause and effect, and it does not describe any B12 product.
An approved product record
The Drugs@FDA record for ANDA 080515 lists a product named CYANOCOBALAMIN with active ingredient CYANOCOBALAMIN, strength 1MG/ML, dosage form and route INJECTABLE;INJECTION, and marketing status Prescription. The database lists FDA-approved drugs, so this shows an approved cyanocobalamin injection exists. It does not make a compounded product approved.
A label statement and reporting problems
The prescribing information for cyanocobalamin injection says parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The sources used here do not say what a visual check can or cannot show about sterility or content.
For adverse reactions, the FDA encourages people with an adverse reaction to a medication, including any compounded medication, to report the problem to their health care professional and directly to FDA. It adds that anyone unsure if a medication is compounded should ask their health care professional.
What this does not tell you
No source used here analyzes the content, strength or sterility of any compounded B12 product. The outbreak findings and the polidocanol samples concern other products and cannot show what a B12 product contains. None of the sources compares compounded B12 products with approved ones. A record for an approved product does not give a compounded product the same status. Questions about a specific prescription are for a licensed provider.