Many athletes believe they need dietary supplements to perform at their best, but this trust in supplements is undeserved. Dietary supplements are regulated in a post-market fashion, which means that no regulatory body approves the accuracy of the label or the safety of the contents before they are sold to consumers.

As such, it is known that any supplement an athlete chooses could contain dangerous, illegal or banned ingredients. There are often no warning signs that a product is unsafe, and many athletes have suffered health problems or positive drug tests and sanctions from using products that are incorrectly labeled or contaminated with dangerous ingredients, such as anabolic steroids, pharmaceuticals, or research drugs. Sometimes, risky or dangerous ingredients are even listed right on the label or identified by a confusing name.

If athletes choose to use supplements despite these known risks, USADA has always recommended that athletes use only dietary supplements that have been certified by a third-party program that tests for substances prohibited in sport.

USADA currently recognizes NSF Certified for Sport® as the program best suited for athletes to reduce the risk from supplements.

Using an NSF Certified for Sport® product significantly reduces, but does not necessarily eliminate, the chance of testing positive and being sanctioned. Under the rules, if an athlete tests positive and establishes the source as a contaminated NSF Certified for Sport® product, the athlete could get a much-reduced sanction, but there likely would still be a consequence.

NSF Certified for Sport® products are recognized by the Certified for Sport label (below) and should be verified by checking on the NSF Certified for Sport® website or the mobile application.

Click here for more information on NSF Certified for Sport® and how to reduce your risk from supplements.

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

The United States Anti-Doping Agency (USADA) today announced the launch of a pilot program for a new blood collection process designed to advance the athlete experience, enable more blood collections, and increase sample longevity.

The process will utilize TAP™, the world’s first push-button blood collection device, through a partnership between USADA and Seventh Sense Biosystems, Inc. (7SBio). Within minutes, and without creating discomfort for the athlete, a small amount of blood is collected and stored inside this state-of-the-art device.

“We all know that blood collections can be unnerving,” said Dr. Matthew Fedoruk, USADA’s Senior Managing Director of Science and Research. “This new device offers far more flexibility than existing blood draw methods, while advancing a painless collection method. Currently, around 10 percent of total samples collected from participating athletes worldwide are blood, due in large part to the complexities and expense surrounding existing blood collection procedures. If this pilot program proves successful, we believe this innovation will drive advancement in global anti-doping practices, making it easier for athletes to give, and anti-doping agencies to collect, ship, and analyze, blood samples around the world.”

The new program is initially being introduced to UFC^® athletes, but WADA-accredited laboratories and other global anti-doping partners will also play an integral role in evaluating and adopting these new technologies designed to benefit athletes worldwide, including doping detection and deterrence programs in Olympic, Paralympic and emerging sport. “It’s an amazing new tool that has the potential to increase doping deterrence and more easily introduce young athletes in an athlete-friendly way to the anti-doping process,” said Dr. Fedoruk.

The TAP device received FDA clearance in early 2017 for the determination of HbA1c, a biomarker used to screen for, diagnose, and monitor diabetes. The device also supports USADA’s larger effort to evaluate alternative testing methods, including the use of dried blood spot testing (DBS). Recent peer-reviewed published scientific studies have shown that DBS testing provides a complementary testing method to current blood collections for a wide range of substances and biomarkers, while also enabling longer storage of blood samples and increasing reanalysis potential as new detection methods become available.

“The introduction of the TAP device in USADA’s anti-doping efforts will result in a simple, convenient, and virtually painless experience for all athletes who are subject to testing,” said Stuart Blitz, Chief Business Officer for Seventh Sense Biosystems. “We believe the TAP device will help advance clean competition on a global scale for generations to come, as the new standard in blood collection. Seventh Sense Biosystems is also developing TAP devices that will enable self-collection at home, in addition to quicker and easier blood collections across the medical and healthcare industry.”

More information about the TAP device and DBS testing is available here: FAQ and Step-by-Step Guide.

About USADA

The U.S. Anti-Doping Agency (USADA) is recognized by the United States Congress as the official anti-doping organization for all Olympic, Paralympic, Pan American, and Para Pan American sport in the United States. In addition, USADA is recognized by the UFC as its official, independent anti-doping agency. USADA is dedicated to preserving the integrity of competition, inspiring true sport, and protecting the rights of athletes. Learn more at www.USADA.org.

About Seventh Sense Biosystems

Seventh Sense Biosystems has designed and developed TAP™, the world’s first push-button blood collection device. It makes the process simple, convenient, and virtually painless. $50 billion is spent annually on diagnostics and consumers are demanding more from the healthcare system. The company aims to create a new standard for blood collection that increases patient compliance with testing orders, leading to faster diagnoses and better outcomes. Future versions of TAP will be designed to enable patients to collect their own blood anywhere. Seventh Sense is funded by Flagship Pioneering and Polaris Partners, as well as Novartis ($NVS), LabCorp ($LH), and Siemens ($SIEGn.DE). For more information: www.7sbio.com.

For more information or media inquiries, email media@usada.org.

USADA would like to remind all athletes that the 2016 Prohibited List went into effect on January 1, 2016. There have been some minor changes from the 2015 Prohibited List, and it is vitally important that all athletes take a moment to re-check any medication they are taking under the new 2016 Prohibited List.

Athletes can search medications purchased in the US, Canada, the United Kingdom and Japan to determine their prohibited status at: http://ufc.globaldro.com/

The full 2016 WADA Prohibited List can be downloaded here

As an example of a 2016 update, it is important to note that there have been new substances or clarifications added to the Prohibited List in various categories, including, but not limited to, meldonium (Mildronate) and insulin-mimetics, including all insulin-receptor agonists.

If an athlete has a legitimate medical need to use a substance or method on the 2016 WADA Prohibited List, they may apply for a Therapeutic Use Exemption (TUE). For more information on TUEs, click here.

USADA has resources available to help. If an athlete has any questions regarding the prohibited status of a substance or method they can email drugreference@usada.org or call Athlete Express at 866-601-2632 (international toll free: +8008-120-8120).

This reminder is also available in the following languages. 

French | Japanese | Portuguese | Russian | Spanish