8:00 – 6:00

Monday to Friday

13827 SW 15 Ter

Miami, FL 33184

+1 786 246 5285

Welcome to ALN Customs Brokers. Fast, knowledgeable with over 35 years of expertise

February 17, 2019

8:00 – 6:00

Monday to Friday

13827 SW 15 Ter

Miami, FL 33184

+1 786 246 5285

DRUGS – PHARMA

The U.S. Food and Drug Administration (FDA) regulates drug products intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and intended to affect the structure or any function of the body of humans or animals.
“ALN provides Registration, U.S. Agent, and Compliance Assistance for U.S. and Non-U.S. Companies in the Drug Industry.”

U.S. FDA Drug Establishment Registration and Listings

Owners or operators of all U.S. and non-U.S. drug establishments that engage in the manufacture, preparation, propagation, compounding, or processing of drugs are required to register and submit a list of every drug in commercial distribution in the United States.

Drug Labeling and Ingredient Reviews

FDA requires that drug labels be indexed using Extensible Markup Language (XML) in Structured Product Labeling (SPL) format. ALN can help modify your drug labeling to comply with FDA regulations. ALN provides revised graphic files ready to be printed or edited, and a report that details the regulations, compliance guides, warning letters, import alerts, and other guidance documents from FDA.

U.S. FDA Drug Master Files (DMF)

A Drug Master File is a submission to FDA that may be used in support of pre-market submissions to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more drugs. ALN’s team of Regulatory Specialists provide guidance as to required elements, formats, and particularities of Drug Master File submissions.

U.S. FDA Self-Identification Requirements for Generic Drug Facilities

Operators of facilities that produce generic drugs and generic drug APIs must submit “self-identification” information to FDA between May 1 and June 1 of each year.

U.S. FDA Outsourcing Facility Regulations

Compounding Pharmacies that register with FDA as Outsourcing Facilities may qualify for exemption from certain FDA approval and labeling requirements. ALN’s Regulatory Specialists can register pharmacies as Outsourcing Facilities as well as help them comply with FDA’s regulations for doing so, including submission of annual drug product reports.

U.S. FDA 3PL/WDD Reporting

Third-party Logistics (3PL) and Wholesale Drug Distributors (WDD) must report to FDA between January 1 and March 31 of each year.

Data Universal Numbering System (D-U-N-S®)

The Data Universal Numbering System (D-U-N-S®) is a business identification system operated by the private company Dun & Bradstreet®. D-U-N-S® numbers are required for drug establishments to register and list products with FDA.

Detention Assistance

Companies shipping products to the United States may find their shipments subject to Detention Without Physical Examination (“DWPE”) by FDA. Products subject to DWPE are held at the port of entry while FDA performs additional scrutiny, testing, and analysis. Delays from DWPE may be lengthy for businesses anxious to deliver products on schedule.

Certificate of U.S. FDA Registration

Companies registered with FDA often are asked by their customers and suppliers to verify their FDA registrations. A Certificate of Registration issued by ALN serves as a third-party verification of your FDA registration.
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