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The Risk

Athletes who have a prescription for a compounded medication or a compounded supplement should be aware that compounding pharmacies are risky. Compounded products are more likely to be contaminated because they are mixed by hand and there is limited regulatory oversight.

In many countries, companies that mass-produce medications have to follow strict rules, but compounding pharmacies can produce medications with little or no regulatory oversight. This means compounded medications have a higher chance of being contaminated or unsterile compared to mass-produced medications that you can buy off the shelf.

Compounding pharmacies may also market compounded supplements as a safe alternative to mass-produced dietary supplements. Unfortunately, the fact that a supplement was prepared in a pharmacy setting or based on a prescription does not eliminate the risk of contamination or a corresponding rule violation.

For example, three UFC athletes recently tested positive because they used compounded supplement products that were contaminated with performance-enhancing drugs.  Even though the compounded products were contaminated and the athletes had prescriptions, the athletes were still sanctioned under the UFC anti-doping rules.


Remember:

Compounded medications are riskier than using mass-produced medications, and supplements are always risky, even when compounded.


Reducing Your Risk

If your doctor wants to prescribe a compounded medication for you, first ask if a commercially prepared drug is available instead. If your medication must be compounded due to allergies or other concerns, ask to talk to the Pharmacist-in-Charge about their compounding pharmacy and its policies. That pharmacist is there to make sure the company meets quality standards to keep patients safe. Tell the pharmacist you are an athlete and need to know if any ingredient is prohibited in sport.

USADA will consider a Therapeutic Use Exemption (TUE) application for a compounded formulation if an athlete’s medical documentation clearly shows a commercial preparation cannot be used instead. It is extremely unlikely that USADA will approve a TUE for specialty compounds of Hormone Replacement Therapies, such as those with testosterone. For more TUE information, visit the TUE Resource Page.

More About Compounding

In the United States, the law says that if there is a commercially available drug, then a doctor is supposed to prescribe that, unless there is something about the drug that makes it unsafe or unsuitable for a patient. Other countries have different laws and regulations around pharmacy compounding that may be more relaxed than commercial drug manufacturing requirements in the United States.

Here are more reasons why compounding pharmacies are risky:

  • In most countries, including the United States, the ingredients used for compounding are government-approved for use, but no pre-approval is required for the final mixtures. Compounded medications may be contaminated with testosterone, DHEA, or other hormones that can lead to a positive test.
  • Compounding pharmacies may not consistently follow the same strict laws as commercial drug manufacturers.
  • Some untrustworthy compounding pharmacies may create unsafe mixtures of ingredients that have never been tested on humans.
  • Each compounded medication is unique and, despite some claims to the contrary, there are no clinical trials proving that each individually-made compounded medicine is measurably safer or more effective than a commercial drug.[1]
  • Compounded pharmacies may inadvertently purchase contaminated or low quality raw ingredients.
  • Compounded drugs may be more susceptible to human error than commercially manufactured drugs, which can result in lower or higher than expected doses, or completely different medications than intended.
  • Some compounding pharmacies don’t have good quality control processes in place and might contaminate products with microorganisms, dust particles, or residue of other ingredients. Serious events (e.g. blindness, paralysis, and death) have been caused by accidental bacterial contamination of compounded medicines for injection.
  • There is no detection or warning system in place to quickly notify the public or protect athletes about unsafe compounded products, or to prevent the continued sales of these products.

[1] All commercial drugs made by drug companies must provide a lot of clinical studies proving safety and effectiveness before they can be marketed in any country.

Other Resources

FDA Inspections and Recalls: https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm339771.htm

References:

Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry. FDA January 2018. https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM510154.pdf

Regulatory Policy Information. U.S. Food and Drug Administration. https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm166743.htm Accessed 5/7/2018

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