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What You Should Know About Amazon OTC Medication Approval ~ Ultimate Guide

OTC Medication Amazon How To Get Approval


Amazon OTC medication approval

Health is wealth, and everyone is ready to do anything possible to enhance their well-being. This includes going to high-class hospitals to get the best medications ever.

Those who cannot afford expensive treatment, however, opt for non-prescription medicines readily available in nearby pharmacies, grocery stores, convenience stores, and charity offices.

Others choose to order their drugs from online stores such as Amazon, which then deliver on time.

Talking about online shopping, Amazon has recently drafted new rules regulating the listing and selling of over-the-counter (OTC) drugs. This makes it challenging for resellers planning to sell OTC medicines through the platform.

Also, although the new selling guidelines may be barriers to sellers, they aim to protect buyers from harmful drugs that may affect their health.

That is why Amazon works jointly with Food and Drugs Administration (FDA) to monitor drug processing, selling, and usage.

Generally, since OTC drugs are sold and used without professional medical examination, anyone selling through the e-Commerce platform must pass all the set standards before they are allowed to list.

Therefore, if you also plan to set up your drug-selling business on Amazon, here is everything you should know about Amazon OTC medication approval.

What Are OTC Medicines?

Over-the-counter (OTC) drugs are those that people can buy directly from drug stores, pharmacies, or gas stations without a doctor’s prescription.

Also called non-prescription, these drugs are used to treat minor medical issues such as cough, headache, pain, diarrhea, and cold.

One can buy OCT medicines conveniently and use them at home without consulting medical practitioners.

The US Food and Drug Administration (FDA) determines if a drug is a prescription or non-prescription. Simply put, a prescription is a medical term that refers to safe and effective medicines used under a doctor’s supervision.

On the other hand, non-prescription medicines are those determined by FDA to be safe and effective for use without a doctor’s intervention.

Generally, OTC or non-prescription medicines contain vital vitamins, minerals, health supplements, and medicinal herbs that make them effective against mild medical conditions.

Anyone buying over-the-counter medicines should, therefore, be keen on their ingredients, recommended usage, and possible side effects.

What Therapeutic Areas Typically Fall Under OTC Treatments?

Most people view OTC treatments as less effective, oddly safe, and rarely abused, especially because they lack doctors’ recommendations regarding their dosage.  They also think prescription medicines as more potent and less dangerous.

However, this is not accurate since the safety and effectiveness of any drug depend on various factors such as dosage and the body’s interaction with medicines.

That means OTC treatments are also as effective as prescription drugs. Maybe this is the reason these quick medical options are quickly getting their way into giant online shops like Amazon.

As a result, FDA classifies OTC medications into various categories based on their effectiveness and the therapeutic conditions they alleviate.

These drugs are available in oral (tablets, capsules, and lozenges) liquids, topical, and film options. Anyone planning to use OTC drugs should, first, understand the therapeutic condition they want to treat and their drug tolerance.

That said, here are the major therapeutic areas that fall under OTC drugs:

  • Cough, cold, and allergy treatments
  • Digestive and intestinal treatments
  • Painkillers
  • Topical OCT drugs

How To Get Ungated in OTC Medications on Amazon

Ungating Amazon OTC medication is not as easy as other subcategories. Remember, OTC meds are under the Health and Personal Care category. And any category that touches human health needs FDA approval before a seller can sell it on Amazon.

As a rule of thumb, any medicine that has not been approved by Food and Drug Administration is considered dangerous, and anyone found selling it should face harsh consequences.

Therefore, besides general ungating requirements for all restricted categories, Health and Personal Care category comes with extra regulations for unlocking. These include:

1. Buy Your Products From The Manufacturer

Unlike other categories where you can buy your products from trusted suppliers or wholesalers and sell them on Amazon, OTC medications require you to buy directly from the manufacturer. That is because Amazon will need you to provide Amazon Standard Identification Number (ASIN) for every product you list. If you don’t buy directly from the brand or manufacturer, Amazon is likely to decline your approval request since you cannot prove the safety and effectiveness of your drugs.

2. Get FDA Registration

Getting FDA certification is a vital step as it helps Amazon to determine if your OTC drugs are safe and effective or not. You can get the FDA registration by visiting the official website and filling out the registration form. The certificate also indicates that you are allowed to sell OTC medications on Amazon or any other platform, provided you follow all the set safety standards. You also need to take a screenshot of the registration page to ascertain that you are taking information directly from the official FDA website.

3. Check The Labeling Guidelines

Even after FDA has allowed you to sell OTC drugs, Amazon can still reject your approval request if you don’t follow its labeling guidelines. These guidelines include but are not limited to:

  • Labels must not state that the drug is FDA-approved if it is not.
  • Labels must not have an FDA logo. The FDA logo is used by the federal government only, and displaying it on the label, product, or product description page can lead to serious legal consequences.
  • Labels must not state that the drug can cure, mitigate, treat, or prevent disease. Such medical claims should only be made by FDA or an authorized medical regulatory body.

4. Other OTC Selling Approval Requirements Include:

  • A Good Manufacturing Practice (GMP) certificate
  • A Certificate of Analysis (CoA) for every OTC meds batch or a 510(K) Premarket Notification.
  • Purchase invoices from the manufacturer or their approved wholesaler. The invoice should indicate that you ordered at least ten units of OTC drugs from the brand. It should also have the brand’s information.
  • An Employer Identification Number (EIN) or Federal Tax Identification Number of your business. This is to show that your business is registered.

Examples of Over-the-Counter Brand Names

Tylenol | Advil | Motrin | Robitussin | Claritin | Benadryl

What Are Amazon Restricted or Gated Categories

Amazon gated or restricted categories are those with strict selling rules that no seller is allowed to sell freely. These categories, brands, and ASINs have specific approval guidelines, and any seller who meets the standards can enjoy a vast market with less competition. That means Amazon only has the power to draw the rules and open gates for more sellers to access the categories. The good news, however, is that Amazon does not always restrict the entire category, like in the previous gating practices.

Instead, it gates subcategories, leaving some products open, even though they might be under gated categories. This explains why there is a short list of gated categories and a long list of restricted products or subcategories such as Amazon OTC medication. Generally, any seller who wants to sell within a gated Amazon OTC medication must request approval.

Why Does Amazon Gate Its Categories?

Most multi-million investments are built on trust, customer satisfaction, and a healthy working environment, and Amazon is no exception. Being a huge marketplace with millions of users globally, Amazon strives to maintain a good relationship with both buyers and sellers by ensuring only high-quality products are in circulation. It achieves this by gating some categories, brands, and ASINs. Therefore, among others, here are the main reasons why Amazon gates its categories:

1. To Monitor Product Standards

One of the first missions of a company is to ensure buyers are offered both high-quality and safe products. It does this by allowing only sellers whose products have undergone stringent quality assessment steps to access highly-demanded categories.

Since the platform is home to millions of brands and buyers, there are high chances of buyers getting counterfeit products.

Hence, it is Amazon’s responsibility to block such products by setting up strict selling rules.

2. To Protect A Brand’s Reputation

Amazon also works jointly with big brands to ensure only authorized resellers can list products from certain brands.

Therefore, to protect the brand’s reputation, Amazon asks sellers to provide legit documentation from these brands to show they are allowed to list their products.

Resellers who do not provide proof of authorization are locked out of certain categories. Many large and well-known brands require pre-approval with them directly, before even applying to Amazon. This is true for both seasoned sellers, and individuals new to the platform.

The rule also applies to those selling white-label OTC medication on Amazon since they must verify the source of their medicines before rebranding them.

3. To Enhance Customer Satisfaction

Besides ensuring buyers can get high-quality products, Amazon OTC medication restrictions also prevent sellers from exploiting buyers. That means only sellers with a positive track record can access the categories and reach buyers.

This enhances customer satisfaction and a positive rating. The company may also limit or dictate maximum pricing to ensure buyers are not being fleeced.

4. Adherence to FDA Regulations

Many items require the approval of the Food and Drug Administration to sell in the US marketplace. No retail platform, website, or other selling venue is permitted to offer non-prescription medicines that are not previously rubber-stamped by the FDA.

The obvious reason for this is safety because specific laws exist to ensure that end users are not harmed. Further, items from foreign countries may not be permitted, as they do not meet standard codes from other regulatory bodies.

Categories And Products That Require Amazon Approval

As stated earlier, Amazon has a long list of gated products and a short list of restricted categories. That is because one category can have more subcategories, which can add up to tens of products.

Therefore, when checking OTC medication Amazon how to get approval, sellers need to consider three ungating levels; category, brand, and product ungating. They should also differentiate between category and product unlocking.

General Guidelines to Get Ungated in Non-Prescription Medicines on Amazon

Whether you are a new reseller or an established FBA seller, selling white-label OTC medication on Amazon should never be a challenge again. Amazon’s mission is to see its users grow, and thus, increase sales and profitability. And this does not matter if you are listing your products in a locked or unrestricted category.

As a result, if you want to expand your selling portfolio by offering non-prescription medicines, here are the general guidelines to get ungated on Amazon:

Sign Up for A Professional Amazon Seller Account

Professional Amazon Seller Account is the backbone of any seller as it records all the activities conducted by the seller on the platform. It is through this account that Amazon can tell your business position and determine whether you are eligible for white-labeling OTC medication on Amazon. Therefore, if you don’t have one, you can create a professional Seller Account which goes for around $39.99 per month.

Analyze And Verify Your Account Health

Creating a professional Seller Account is not enough. You still need to maintain its health to maximize your chances of getting approved.

Maintaining a healthy account includes meeting your customers’ expectations and adhering to Amazon’s business code.

That means you should have a timely shipping record, good customer relations, competitive pricing, and avoid violating Amazon’s policies.

To check your account health, go to the Account Health section on the Seller Central Account and click on the Performance menu.

Check Specific Category Ungating Guidelines

Each category has specific ungating instructions, and you need to check them before requesting approval. Some categories are complicated, while others have simple instructions that even new sellers can unlock easily. For example, some categories require sellers to have at least three years of selling experience and running websites. Therefore, for you to list Amazon’s top-selling OTC medication, you need to check specific OTC-ungating requirements, as discussed above.

Choose A Reputable Supplier

Getting a reliable supplier is also a vital step, especially as your demand curve grows. Amazon will also ask you to provide legitimate invoices from trusted suppliers whose products fall under gated categories. After choosing a supplier, you need to place at least three orders, with each order having at least ten pieces of the restricted product.

Retailers are not considered suppliers. You cannot go down to your local store and purchase a bunch of items for resale. The products need to come from verified wholesalers and distributors.

Be sure to do your research before sourcing and paying for any potential sales items. In the case of OTC drugs, you need to buy from an FDA-approved manufacturer to maximize your chances of approval.

Prepare Your Documents

Before submitting your approval request, you need to prepare your documents, which include recent purchase invoices from reputable wholesalers. These scanned copies of individual invoices should have all the ASINs written next to the product name. Price and other confidential information should be locked for wholesaler privacy. As a general note, it is usually best to send the documents in PDF format, so it can be easily seen that they have not been revised. You may also be required to send information about your status or business trading information, especially when dealing with private-label over-the-counter meds.

Request Approval

With all the documents and other requirements ready, you can proceed to request Amazon OTC medication approval using the following steps:

  • Getting a Pro-Merchant Status. You can get the status at only $39 per month. It becomes easier if you already have a Professional Seller Account.
  • Search for the item you want to list
  • Go to the Listing Limitations Apply
  • From the new menu, click on the Apply to Sale button
  • Lastly, click on the Request Approval button

Guidelines To Ungate Specific Categories on Amazon

Selling non-prescription medicines goes a long way in understanding what the subcategory entails and how to ungate it on Amazon. For instance, the Grocery and Gourmet Food category requires sellers to have authorization from regulatory bodies like Food and Drug Administration. On the other hand, some categories require sellers to have more years of selling experience and a good online presence. Therefore, if you intend to list Amazon’s top-selling OTC medication, you need to consider the following best tips to maximize your chances of getting ungated:

  • Getting a Pro-Merchant Status. You can get the status at only $39 per month. It becomes easier if you already have a Professional Seller Account.
  • Maintaining your order defect rate below 1%. Since it is challenging to tell how fast some products can go bad, it is crucial to ensure your orders move as fast as possible to minimize cases of selling defective products.
  • Maintaining your pre-fulfillment cancel rate below 2.5%. A higher pre-fulfillment cancel rate can impact your account health negatively. Thus, you need to lower your order cancelation to maximize your approval chances.
  • Lowering your late shipment rate to below 4%. Timely delivery is one way to get customer trust; hence, you should try as much as possible to avoid late shipment.
  • Acquiring child product certificate. A Child Product Certificate is a must-have requirement if you want to sell in children’s categories such as Toys and Games. It also proves that you adhere to both local and federal product safety laws.

Final Thoughts on Amazon OTC Medication Approval

The urgent need to deal with minor conditions such as stress, pain, headaches, and skin disorders has seen many people switch from prescription (Rx) to over-the-counter (OTC) medications. This has led to growth in the OTC market, which is estimated to be currently at $125 billion. Still, the market is predicted to grow at a rate of 5% over the next years.

So, what does this mean to online sellers? Sellers who strategically manage to list non-prescription medicines on giant online stores such as Amazon are guaranteed to make substantial revenues. That is because the platform has millions of people looking for quick ways to alleviate certain disorders. But first, understanding Amazon OTC medication approval is important.

Amazon’s new health and personal care selling guidelines are likely to lock out many sellers who do not fulfill all the requirements needed to sell OTC medications.

As such, any seller planning to sell private label over-the-counter meds should read all the OTC medication Amazon-how to get approval requirements before starting the process. Luckily, the above guide simplifies the journey by providing everything such sellers should know.

Vinny Ly

Vinny Ly

I have been helping Amazon sellers sell more inventory and increase revenues by guiding them through the process of ungating difficult Amazon categories, brands, and products.

I have spent years doing this for my own ventures and have helped countless other businesses reach inaccessible markets and tap into lucrative expansion.

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