Tag: Drug Listing

PRIVATE LABEL DISTRIBUTOR

A firm that does not participate in the manufacture or processing of a drug but markets and distributes under its own trade/brand name, and labels a drug product made by someone else, is referred to as a Private Label Distributor or PLD.

The private label distributor takes on the responsibility of marketing, branding, and selling the products, while the manufacturer is responsible for producing and supplying the products.

PLDs do not have a registration or listing obligation for drugs since they do not manufacture or process in their facility.

They may elect to submit listing information for a drug they do not manufacture or process directly to the FDA by themselves or if they do not want to list, the manufacturer must submit the drug listings on behalf of the private label distributor.

If the PLD submit the listings under their NDC number, they assume full responsibility for compliance with all listing requirements.

To be a successful private label distributor, it is important to have strong relationships with manufacturers, a clear understanding of market trends and consumer preferences, and effective branding and marketing strategies.

The steps involved in drug listings can be checked at https://www.fdahelp.us/otc-drug-registration-process-fda.html

Liberty Management Group Ltd, provides assistance with drugs establishment registration, NDC labeler code request, Drug listings and US agent service to foreign facilities.

Sudha S

Regulatory Consultant

Email: office@libertymanagement.us

www.fdahelp.us

BASICS OF IMPORTATION – DRUGS

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.

  1. FDA Drug Establishment Registration
  2. Drug Listing
  3. NDA or ANDA approval (If applicable)
  4. Conducts field examination and analyzes samples of drugs products to make sure they comply with standard and label requirements.
  5. 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

www.fdahelp.us

NATIONAL DRUG CODE (NDC) – AN OVERVIEW

According to the Drug listing act of 1972, all registered drug establishments must provide the current list of all drugs manufactured, processed, prepared, propagated, compounded or processed for commercial distribution in their facility to FDA. These drugs products are identified and reported by using a unique three segment number called National Drug Code (NDC), which serves as universal product identifier for human drugs.

NDC number is a unique 10-digit, 3–segment numeric identifier assigned to each drug listed under Section 510 of FD&C act. Each NDC number identifies the labeler, product and the trade package size of the drug.

  • The first segment of NDC is known as labeler code, which is a unique 5 digit number assigned by FDA to each establishment that manufactures (including contract manufacturers, re-packers or re-labelers) or distributes (under its own name- Private label distributor).
  • Second segment, which is the product code, identifies the specifications (strength, dosage form and formulation) of a drug for a particular manufacturer.  This denotes that different formulations or different strengths of the same formulation should be assigned different product codes.
  • The third segment, the package code, classifies package sizes and types. The second and third segments of NDC should be assigned by the labeler. The NDC will be in one of the following configurations: 4-4-2, 5-3-2, or 5-4-1.

NDC Labeler code request to FDA should be submitted in SPL (structured Product Labeling) format via FDA ESG (electronic submission gateway). Labeler is responsible for each NDC directory entry submitted through SPL files.  Entry in NDC directory doesn’t indicate that FDA approved or verified the information of the drug. Assignment of NDC number to non-drug products is strictly prohibited. Under FD&C act, registration of a drug establishment or assignment of NDC number does not denote that FDA’s approval of the company or its products.

Even though NDC number is a mandatory requirement, but it is not required to appear on all drug labels and including the label of any prescription drug carton given to a consumer.  However, if the same drug product that are sold or used in the hospitals are required to put bar code on their products.

NDC Directory does not include animal drugs, blood products, API (Active Pharmaceutical Ingredients), drugs manufactured exclusively for a PLD, or drugs that are marketed as a part of a kit or combination product or inner cover of a multi-level packaged product not marketed separately.

Liberty Management Group Ltd, provides assistance with drugs establishment registration, NDC labeler code request, Drug Listing and US agent service to foreign facilities.

Sudha S

Regulatory Consultant

Mail: office@libertymanagement.us

http://www.fdahelp.us

OVER-THE-COUNTER (OTC) DRUG PRODUCTS

Over-the-Counter drugs (OTC)  also known as nonprescription drugs are medications sold directly to consumers without a prescription from a physician. OTC drugs are in general considered as safe and effective for use by the consumers without getting treatment from a healthcare professional.  There are more than 300,000 OTC drugs are marketed with about 800 active ingredients.

Although there are more than 80 therapeutic categories of OTC drugs, starting from acne products to weight management drugs, FDA is not approving OTC products, but Center of Drug Evaluation and Research (CDER) ensures that OTC drugs are properly labeled and its ingredients listings. For each category, FDA developed an OTC drug monograph and published in the Federal Register. OTC drug monograph provided guidance which covers doses, acceptable ingredients, formulations and labelling requirements.  When the company adheres to OTC monograph, it can make and market an OTC drugs without FDA’s pre-approval.  OTC monographs defines the safety, efficiency and labeling of all OTC active ingredients. The drugs for which the active ingredients is not OTC monograph, has to apply for New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

FD&C acts requires firms that manufacture, contract manufacture, repack or re-label or salvaging of OTC drugs in the United States or that are offered for import in the U.S are required to register with FDA and renew their registration annually. Also domestic and foreign establishments must list all drugs that they manufactured, prepared, propagated, compounded, or processed for commercial distribution in the U.S. Foreign firms are required to identify a U.S agent and importers at the time of registration.

FDA Drug establishment registration needs to be submitted electronically using Extensible Markup Language (XML) files in the Structured Product Labeling (SPL) format. The firms must use FDA’s Electronic Submission Gateway (ESG) to submit SPL files.

Private Label Distributors (PLD) are not required to register their establishment with FDA, however they have to apply for their own Labeler code and list their drugs with FDA. FDA has a released a list of summary of registration and listings requirements for the manufacture or distribution of human pharmaceuticals, which can be seen at https://www.fdahelp.us/Pdf/Drug.pdf

Drug establishments that are registered with FDA must list all the products they manufacture for commercial distribution under their own labeler code, which includes the API manufacturers, bulk manufacturers, contract manufacturers, re-packers and re-labelers.

FDA has published a regulation establishing standardized content and format for the labeling of OTC drug products (Drug Facts labeling). The Drug Facts labeling for OTC drug products is intended to make it easier for consumers to read and understand OTC drug product labeling and use OTC drug products safely and effectively. All drugs or drug products in finished package form is considered as misbranded if it does not comply with FDA labeling requirements.

Liberty Management Group provides assistance with drug establishment registration, drug listing and label review.

Sudha S

Regulatory Consultant

Mail: office@libertymanagement.us

http://www.fdahelp.us