a) Substances approved by the official pharmacopoeia or prescription.
b) A substance used to diagnose, cure, alleviate, treat, or prevent disease.
c) Substances (other than food) intended to affect the structure or any function of the body.
d) Substances intended to be used as pharmaceutical ingredients but not equipment or components, parts or accessories of equipment.
e) Biological products are included in this definition and are usually covered by the same laws and regulations, but their manufacturing processes (chemical and biological processes) are different.
a) The FDA defines over-the-counter drugs (OTC) as safe and effective for use by the public without a doctor's prescription. Disposable hand sanitizer, disinfectant, disinfectant hand sanitizer, spray disinfectant, disinfectant wipes, disinfectant cotton, scald paste, hair spray and so on belong to OTC.
b) It is used for human body. If it is used to disinfect the environment or objects, it is within the scope of EPA control.
c) Some products may be both OTC and cosmetics. For example, toothpaste containing fluoride, deodorant which is also an antiperspirant, and moisturizing liquid and cosmetics sold under the slogan of sunscreen.
OTC products FDA requirements
a) Enterprise registration: manufacturing, packaging drugs or other related enterprises (such as brand side) need to register with FDA.
b) Product registration: OTC drugs to be sold in the United States must register the corresponding products and specifications with FDA.
c) Product label: the product label must be made in accordance with FDA requirements and contain drug facts, which shall reflect the active ingredients and content, purpose, use method, warning, storage conditions, inactive ingredients, etc.
d) Quality management system: FDA will spot check whether the enterprise's quality management system meets the requirements of 21 CFR Part 210 (CGMP)
Information required for registration - Product Registration
a) Proper name: product name, that is, the name of the product by the enterprise.
b) Non proprietary name: the generic name of the drug. Generally, the main active ingredients of the product are regarded as the generic name of the product.
c) Product packaging specification / net content: different forms of products have different expressions. For example, hand sanitizer / disinfectant is expressed in volume units (ML, l); Disinfectant wipes, expressed in PCs units; The mass of drug paste is expressed in mg.
d) Form (dosage form): the state of a drug when it is used. For example, disposable hand sanitizer is liquid (Liquid), spray disinfectant is spray (Spray), disinfectant wipes are Cloth, paste medicine is Paste.
e) Medication route: the way of drug use. For example, disinfection products such as hand sanitizer are topical, and some drugs need to be taken orally.
f) Active ingredient and content: the key ingredient to exert drug efficacy. For example, alcohol is the key ingredient of disposable hand sanitizer. Different content description methods should be used for different forms. The alcohol in disposable hand sanitizer can be written as 75% v / V, the alcohol in disinfectant wipes can be written as 5ml / PCs or 75% v / V, and the active ingredient in paste can be written as 5mg / 100g. The Unii number of the component is also required.
g) Inactive ingredients: for other ingredients except active ingredients, the specific content may not be written, but it must have Unii number.
h) Unii number: FDA's number of drug ingredients. The ingredients submitted to FDA must fill in the Unii number. You can enter the English name or CAS number of the product on the FDA website to query the corresponding Unii number. https://fdasis.nlm.nih.gov/srs/srs.jsp
1. Labeler Code: brand number. The number is assigned by FDA after submitting the application. It is generally 5 Arabic numerals, such as 71234.
2. NDC: National Drug Code, i.e. national drug code of the United States.
3. Product NDC: the NDC number of the product, usually 7 or 8 Arabic numerals, such as 71234-001 or 71234-01. Generally speaking, the product NDC of the same formula is different for different formulas.
4. NDC package code: the NDC number of the package, usually 10 Arabic numerals, such as 71234-001-01 or 71234-01-001.
5. Generally speaking, the first 8 or 7 digits are the same for the packaging code of the same formula and different specifications, and only the last 2 or 3 digits are different.
6. Package description: package description, which describes the specifications of the package, such as 50ml in 1 bottle, 20g in 1 tube and 30cloth in 1 bag.
About US Agency
A U.S. agent must reside or maintain a place of business in the United States and must obtain a dunpak code.
The responsibilities of the U.S. agent are limited, including:
Assist FDA in communicating with foreign companies; Answer questions about equipment imported or supplied to the United States by foreign institutions; Assist FDA in arranging inspections of foreign institutions; And if FDA is unable to contact foreign agencies directly or quickly, FDA may provide information or documents to U.S. agents, and such action shall be deemed to be equivalent to providing the same information or documents to foreign agencies.
OTC product registration query (you can find it 48 hours after product registration):
FDA will spot check the manufacturers of OTC drugs. The enterprises that are spot checked need factory audit. The audit standard is based on 21 CFR Part 210, referred to as cGMP for short;
FDA announced that all factory audits will be suspended in April 2020 and will be resumed in the future;
In early April 2020, FDA issued a quick application guide for wash free absorbent. At present, the application for FDA registration of such products is relatively fast.
After registration, the data shall be resubmitted to FDA from October 1 to December 31 every year.
After the registration is completed, the product label needs to be made according to the FDA OTC product label requirements before it can be legally sold;
The label format is shown in the figure;
In addition, the registered NDC package code needs to be marked on the product package;
If there is a confirmed U.S. importer, the importer must be added to the enterprise's registration information (the importer's name, Deng Bai's number, e-mail and telephone number must be provided).
Cycle: about 1 week for enterprise registration and about 3 weeks for product registration
About annual fee (new policy in 2021)
On March 26, 2021, FDA issued a notice on charging user fees for OTC monographs
Fee Rates Under the Over-the-Counter Monograph Drug User Fee Program for Fiscal Year 2021
FDA will charge the following fees
1. Facility fees:
a. (MDF) direct manufacturer and brand $20322
b. (CMO) OEM $13548
2. Omor fee (this fee is the fee for OTC products (NDA or anda) requiring FDA approval, that is, products with application number)
Class 1 $500000
Level 2 $100000
1. The enterprise fee shall be paid before May 10, 2021.
2. Enterprise fees are only for enterprises registered or updated in 2020.
3. During the epidemic period, enterprises that only produce hand sanitizer products will not be charged.
4. The manufacturer of wash free hand sanitizer or wipes does not need to pay an annual fee. The so-called wash free means that there is no water in the product. At the same time, the enterprise was registered with FDA for the first time after January 27, 2020.
5. Newly registered enterprises in 2021 do not need to pay fees in that year, but they should pay in 2022.
6. Payment is required only if the registration category is OTC monograph not final or OTC monograph final.
7. Enterprises that are only brands and do not produce OTC products do not need to pay annual fees.
How to determine the classification of products?
Judging from the active ingredients of the product, if one or more of the active ingredients of the product are in the OTC monograph not final or OTC monograph final list issued by FDA, it can be registered according to this category, otherwise it can only be applied according to Unapproved draw other.