FDA regulates a range of products which includes food (human and animal consumption), medical products (drugs, devices and biological products), radiation-emitting electronic products, tobacco products and cosmetics. All imported shipments of FDA regulated products are evaluated by FDA and needs to comply with same regulations as of domestic products. The products that are offered into U.S including personal items must be declared to U.S. Customs and Border Protection (CBP). CBP will refers all FDA –regulated products to FDA for review. Mostly, importers will hire a custom broker to help them in submitting necessary entry documents and applicable payments to CBP on behalf of the importer. FDA regulated products are refused to enter in US commerce, if they appear to be adulterated, misbranded, or restricted for Sale. Refused products needs to be destroyed or exported from U.S within 90 days.
DRUGS IMPORTATION
FDA will verify compliance with the following requirements at the time of importation.
- FDA Drug Establishment Registration
- Drug Listing
- NDA or ANDA approval (If applicable)
- Conducts field examination and analyzes samples of drugs products to make sure they comply with standard and label requirements.
- FDA will make sure that the manufacturer is in not is the list of foreign manufacturers who are not in compliance with drug GMP or import alert.
FDA will verify the manufacturer’s registration and listing by comparing the submitted information to CDER’s registration and listing databases. If the information does not match, FDA will ask for additional information or may detain the product. If the product requires a NDA, ANDA or IND and if does not have it, then FDA will subject the product to refusal.
Foreign establishments whose drugs are imported into United States are required to register with FDA and submit their drug listing information of their products intended for marketing in U.S. If the manufacturer has not registered, they need to register with FDA within 5 days after submitting their application. Also all foreign manufacturers are required to identify a U.S. Agent. FDA Drug establishment Registration and drug listing must be submitted to FDA electronically via CDER unless waiver is granted.
Drug products imported into the United States are subject to FDA labeling requirements. FDA will review the drug labels at the time of importation to check whether they are in compliance with FDA regulations. Specific drug labeling requirements are determined by the type of drug product. OTC drugs, prescription drugs, and drugs imported for drug effectiveness studies are subject to specific labeling requirements in addition to the general drug label requirements.
Liberty Management Group , a leading FDA consulting group in the United States provides assistance with drug establishment registration, drug listing and label review and US agent service for foreign drug establishment firms.
Sudha S
Regulatory Consultant
Mail: office@libertymanagement.us
Hello, I want to start importing anti-aging cream from Colombia. Do i need to register too if the manufacturer is already registered? Please advise the fee and time required. Is there an expedited service?
In general drug importer does not need registration, but let us know whether you are a PLD (Private Label distributor) , if so, you don’t need to register your establishment with FDA, but you need to have your own labeler code Labeler code and drug listing with FDA. Please check the following link for our fees structure https://www.fdahelp.us/fda-fees.html
I am not sure what PLD means. The company in Colombia is going to manufacture and ship the ready products to me. I am only going to sell the products here. Do i need to register or list?
PLD means Private Label Distributor. If you are going to put your company labels in the products, then you need to have your own labeler code and list the drugs with FDA. If you are only a domestic distributor then you do not need to register with FDA.
I am the regulatory pharmacist for a Brazilian cosmetic company. We are looking for company in America to register our sunscreen. Will your company be able to assist in this regard? Could you please provide me the OTC monograph list of FDA? TIA
Sure, we can help you with FDA registration. As per FDA. Sunscreen comes under drugs, so please complete our online form https://www.fdahelp.us/drug-registration-form.html. Also you can check OTC monograph at
https://www.fda.gov/media/75758/download for OTC monograph.
Where can i find a list of import alerts for drugs?
You can search the list at https://www.accessdata.fda.gov/cms_ia/industrygroup_6.html
Help! My drug shipment is on detention by FDA. They say my registration is incorrect and importer info is missing. My importer is registered. How do i make sure my shipment is released?
Please ask the manufacturer to update their drug establishment registration with importer information.