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Next Steps In Response to the CARES ACT

Last week, the Food and Drug Administration (FDA) issued warning letters to a number of companies for illegally selling over-the-counter (OTC) skin lightening products that contained hydroquinone and did not meet proper requirements. These warnings are a follow-up to the Coronavirus Aid, Relief, and Economic Security Act (the CARES Act), which was signed into law in March 2020.

Need a refresher on the CARES Act?

Its purpose is to provide emergency assistance and health care response for individuals, families, and businesses affected by the COVID-19 pandemic.

However, subtitle F of the act imposes substantial reform of the regulatory framework for nonprescription drugs, which is the largest shake-up of the review process for OTC drugs since the process was first implemented. Given these changes, the CARES Act goes far beyond addressing the current public health emergency and has a major impact on our access to commonly-used ingredients, such as hydroquinone.

Let’s take a closer look at how the CARES Act affects the use of hydroquinone.

Hydroquinone is a category 1 substance on the FDA’s “503B Bulk Drug Substances List,” meaning that items from 503B facilities with this ingredient are not allowed to be dispensed at this time unless they have been FDA-approved through the new drug application (NDA) process. 503B pharmacies typically produce large batches of compounded drugs for “office use.” The activities of such facilities have been severely restricted and are now unable to collaborate with physicians on customized formulas until the compounds have been submitted for testing and stability studies.

If prescribers wish to use hydroquinone for their patient’s aesthetic issues, they must engage the services of a 503A compounding pharmacy, such as VLS Pharmacy and New Drug Loft. 503A compounding pharmacies are traditionally patient-focused compounding facilities, meaning that they are able to fulfill individual, patient-specific prescriptions approved by a prescribing practitioner. There is a strict requirement, however, that the medications must be shipped directly to the patient and not dispensed from the prescriber’s office.

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It’s also important to note that physicians must comply with FDA guidelines as well as state and local pharmacy regulations before filling prescriptions with hydroquinone.

So what’s happening now?

The FDA is advising consumers not to use OTC skin lightening products due to potential side effects, including skin rashes, facial swelling, and ochronosis, which can be permanent. Additionally, as mentioned above, the agency sent warning letters to 10 companies for continuing to sell and market products containing hydroquinone without an approved NDA.

It’s important to note that there are no FDA-approved OTC skin lightening products. The only FDA-approved drug containing hydroquinone is Tri-Luma, which can be prescribed for short-term treatment of dark spots associated with melasma on the face. It should only be used under the supervision of a licensed healthcare professional. 

Fortunately, VLS Pharmacy and New Drug Loft can help you and your patients during this challenging time.

We are able to support physicians who wish to continue prescribing hydroquinone-based treatments for their patients. However, monitoring of the patient’s progress should be undertaken with all of these potential side effects in mind. Also, as previously mentioned, the compounding must be performed specifically for the patient, and the medication must be shipped directly to the patient and not to the prescriber’s office.

Given the uncertain future of hydroquinone and the current regulations invoked by the CARES Act, which prevent OTC dispensing of the ingredient, alternative agents with comparable efficacy for treating melasma, sun damage, and hyperpigmentation are urgently required. Several such options are available, including:

  • Tranexamic acid (trans-4-aminomethyl cyclohexane carboxylic acid) was first registered as a blood-clotting antifibrinolytic drug. Its use was extended to a dermatological application as a general depigmenting agent for hormone-induced, ultraviolet-induced, and post-inflammatory hyperpigmentation.
  • Niacinamide is a form of vitamin B3 that has been shown to be effective in reducing the skin’s pigmentation when applied topically as a 5% niacinamide moisturizer. It is already part of many dermatologists’ treatment packages because it’s also efficacious in the treatment of acne.
  • Azelaic acid is a naturally occurring dicarboxylic acid found in wheat, rye, and barley. The 15% topical gel of azelaic acid is FDA-approved for the treatment of mild to moderate rosacea. The use of azelaic acid topical gel is also often applied off-label for the treatment of acne and hyperpigmentation. Thanks to its excellent safety profile and how well it is tolerated, azelaic acid, either as a monotherapy or in combination, is also an effective first-line or alternative treatment for hyperpigmentation.
  • Kojic acid is found naturally occurring in several different types of fungi and as a by-product of fermentation in certain foodstuffs. Kojic acid inhibits melanin production, making it an effective treatment for hyperpigmentation. It has been approved for use in cosmetic products in concentrations of 1% or less. Kojic acid is not tolerated as well as azelaic acid, especially in patients with sensitive skin. Most side effects are the symptoms of contact dermatitis, such as redness, irritation or itchiness, rashes, swollen skin, and pain or discomfort.
  • Retinoids are a class of chemicals related to vitamin A. Topical application of a first-generation retinoid, called tretinoin (retinoic acid), is effective in the treatment of post-inflammatory hyperpigmentation of darker skins. Tolerance varies across individuals and may improve with use over time. It is important, then, to closely monitor patient progress when using retinoid therapies.

Reach out to our team to learn more about the CARES Act and best practices and to partner with our experts on custom compounded medications for your patients.

All medications from VLS Pharmacy and New Drug Loft are prepared in a lab that follows safety and quality standards per our status as a 503A pharmacy.



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