Category: fda registration drug

DMF – DRUG MASTER FILES

A Drug Master File (DMF) is a document submitted by a drug manufacturer to US FDA which is used to provide confidential detailed information about facilities, procedures, or things used in the manufacturing, processing, packaging, and storing of one or more human drugs. A DMF is submitted when more companies work in partnership to manufacture a drug product, which allows the company to protect is its intellectual property rights from its partner while complying with regulatory constraints as well for disclosing of processing procedures.

DMF’s are submitted to support regulatory regulations and prove the quality, safety and effectiveness of a product for getting Investigational New Drug Application (IND), New Drug Application (NDA), Abbreviated New Drug Application(ANDA), another DMF and Export Application. However, DMF submission is NOT a substitute for an IND, NDA, ANDA or Export Application. As per FDA regulation, DMF submission is not required by law, it is solely depends to submitters discretion.

As per FDA, there are five types of DMF’s

  • Type I  : Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)
  • Type II  : Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product
  • Type III :  Packaging Material
  • Type IV  : Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation
  • Type V :  FDA Accepted Reference Information

All DMF submissions must be in the English language which should contain transmittal letter, administrative information about the submission and must include specific information about the DMF type.

All foreign DMF holders are required to appoint an U.S agent, however domestic DMF holders do not need a representative to submit it.

DMF holders should submit an annual report on the same date of their original submission.  Annual report should contain all the information including name and address of DMF holder, corporate headquarters, Manufacturing/ processing facility, contact for FDA communication, agents (if any),statement of commitment and signed statement by the DMF holder assuring that the DMF is current.

Starting from May 5, 2018 onwards, new DMFs other that Type III, as well as all documents submitted to existing DMFs excluding Type III are required to submit DMF using Electronic Common Technical Document (eCTD).  DMFs that are not submitted through eCTD after May 5, 2018 will be rejected, however for Type III DMFs the requirement will be effective from May 5, 2020 onwards.

Liberty Management Group Ltd, a leading FDA consulting group in the United States, provides assistance DMF eCTD submissions, US agent service, DMF closure and reactivation request submission to FDA.

Sudha S

Regulatory Consultant

Mail: office@libertymanagement.us

http://www.fdahelp.us

DRUG LABELING

Drug label is a printed information which is included with any OTC drugs, prescription drugs or any dietary supplements. Drugs labels are regulated by FDA and provide information to healthcare providers and patients on safe and effective use of the product. The information on the labels must be accurate and should not be misleading

All drugs or drug products in finished package form is considered as misbranded if it does not comply with FDA labeling requirements. The labels needs to have the name and place of business of the manufacturer, packer or distributor.

All registered drug establishments which includes API manufacturer, bulk manufacturer, contract manufacturer, repackers, relabelers are required to list their products under their own labeler code, however NDC number is not required to appear on all drug labels, including the label of any prescription drugs given to a customer.

Drugs labels should contain all drug facts which includes active ingredients, purpose and uses of the drug, directions, other information, inactive ingredients, phone numbers if there is any questions or comments.

When there is an expiration date on the drug products, it should appear on the container and also in outer package. However, if it is a single dose drug product packed in individual cartons, the expiry date should be on the individual carton not on the product container.

Manufacturers, Contract manufacturers, repackers, relabelers, and private label distributors of a human prescription drugs or an over-the-counter (OTC) drugs that is regulated under the FD&C act are not required to have bar code on the products. However, if the same drug product that are sold or used in the hospitals are required to put bar code on their products.

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

Sudha S

Regulatory Consultant

Email : office@libertymanagement.us

www.fdahelp.us

HOMEOPATHIC DRUG REGISTRATION AND LISTING WITH FDA

Homeopathy is an alternative medicine created by a German Scientist which claims that a substance that causes the symptoms of a disease in healthy people would cure similar symptoms in sick people.

Any drugs labeled as homeopathic has to be listed in the Homeopathic Pharmacopeia of the United States (HPUS).

FDA does not approve products labeled as homeopathic products. The products labeled as homeopathic contains a range of substances resulting from plants, healthy or dead animal or human sources, minerals and chemicals.

Homeopathic products currently marketed here in US have not been reviewed by FDA to check its safety and effectiveness to treat, diagnose, cure or prevent any disease or conditions.

Under FD&C act, Homeopathic drugs products are subject to same regulations as OTC drugs.

As per FDA, companies which manufacture, prepare, propagate and compound homeopathic drugs must register with FDA as drug establishment and list their drugs with FDA by creating a SPL.

Homeopathic drug product labeling must comply in same regulations as any other drugs products.

Liberty Management Group Ltd, provides assistance with homeopathic drugs establishment registration, drug listings and US agent service to foreign facilities.

Sudha S

Regulatory Consultant

Mail : office@libertymanagement.us.

www.fdahelp.us

COMPOUNDING PHARMACY REGISTRATION

Compounding is a method of mixing, combines or alters ingredients of a drug to manufacture a medication custom made to the needs to individual patient under the supervision of licensed pharmacist, or a licensed physician or an outsourcing facility.

Compounded drugs are not FDA-approved. FDA does not check these drugs to assess their safety or efficiency before they reach patients. It is only the responsibility of State board of pharmacy to monitor state-licensed pharmacies that compound drugs in accordance with regulation of section 503A of the FD&C, although FDA has some control over their operations.

Outsourcing facilities registered under section 503B are regulated by FDA and must stratify cGMP requirements and will be inspected by FDA.

An outsourcing facility is geographic location or address where the drugs are compounded. An outsourcing facility has to be in compliance with section 503B and must comply with cGMP requirements.

If an outsourcing facility engages in compounding non-sterile drugs and animal drugs, mixing, diluting or repacking biological products do not need to register as an outsourcing facility as the drugs compounded are not eligible for exemption form 503B for FD&C act.

All Outsourcing facilities that engages in compounding sterile human drugs needs to register with FDA using CEDR system.

All outsourcing facilities must renew their registration between Oct 1st and Dec 31st and pay the annual establishment registration fees for every year as long as they wish to register as an outsourcing facility.

PRODUCT REPORTING PROCEDURES

The drug products manufactured from December 1 through May 31 must submit drug product reporting between June 1 and June 30. In the same way, the drug products manufactured from June 1 through November 30 must submit drug product reporting between December 1 and December 30.

Each product report must include all sterile and non-sterile drug compounded in the outsourcing facility must include active ingredient and its strength, NDC number of source drug or bulk active ingredient, dosage and route of administration, package description, number of individual units manufactured and NDC number of end product (If assigned)

LMG provide assistance with FDA registration of Outsourcing facilities.

Sudha S

Regulatory Consultant

Mail – office@libertymanagement.us

http://www.fdahelp.us

Published on: January 9, 2019