Drugs

Beginning October 1, 2018, the U.S. Food and Drug Administration (FDA) will require electronic format for new Veterinary Master File (VMF) submissions, including amendments.  FDA states that it will not accept paper VMF submissions after this deadline.

What Is A VMF?

FDA defines a VMF as “a submission that provides confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of veterinary drugs and drug substances.” A VMF holder can authorize third parties to reference the VMF’s material in support of submissions such as investigational new animal drug applications (INADAs) and abbreviated new animal drug applications (ANADAs) without disclosing trade secrets to industry.

What Are FDA’s Requirements For Electronic VMFs?

FDA does not require a specific format for electronic VMFs, but the FDA Center of Veterinary Medicine (CVM) does provide recommended guidelines for files in an electronic submission.  After reaching out to FDA, the Agency has informed Registrar Corp that they will accept and encourage VMF submissions in Common Technical Document (CTD) format.  Note that CTD is not the same as the Electronic Common Technical Document (eCTD) format required for most types of Drug Master Files (DMFs) and drug applications.

Beginning October 1, VMFs must be submitted through FDA’s Electronic Submissions Gateway (ESG) using the CVM version of the eSubmitter software.  Electronic submissions to CVM require registration with both ESG and the CVM Electronic Submission System (ESS).  These registrations may take several weeks as they involve multiple back-and-forth communications with FDA, including written letters and test submissions.

Alternatively, you can make a time-consuming process quick and easy by having an experienced FDA Regulatory Specialist, such as Registrar Corp, assist with your VMF submissions.  Registrar Corp can convert your paper VMFs to electronic format and submit them to FDA on your behalf.  For more information, call us at +1-757-224-0177 or chat with a Regulatory Advisor 24/7 at regstaging.wpengine.com/livehelp.

U.S. FDA Deadline Approaching for Prescription Drug Labels: New Product Identifier Requirements

Under the Drug Supply Chain Security Act (DSCSA), manufacturers, packagers, and repackagers of human prescription drugs must affix or imprint a “product identifier” to each package and homogenous case of product intended to be introduced in a transaction into US commerce. This process is known as “serialization.”

Compliance Deadlines

Manufacturers, packagers and repackagers of human prescription drugs must comply with this new requirement by November 27, 2018.  After this date, the U.S. Food and Drug Administration (FDA) will consider drug products that do not bear a product identifier to be misbranded and in violation of FDA regulations.

Furthermore, industry will not be permitted to buy or sell prescription drug products that are not encoded with a product identifier after the following dates:

• November 27, 2018 for repackagers
• November 27, 2019 for wholesale distributors
• November 27, 2020 for dispensers

Formatting a Product Identifier

A product identifier should include the product’s National Drug Code (NDC), unique serial number, lot number and expiration date in human and machine-readable formats.

The machine-readable format should be a 2D data matrix barcode when affixed to or imprinted on a package (the smallest individual saleable unit of product for distribution by a manufacturer or repackager that is intended by the manufacturer for ultimate sale to the dispenser of such product) or a linear or 2D data matrix barcode when affixed to or imprinted onto a homogenous case of product (a sealed case containing only product that has a single NDC number belonging to a single lot).

 Implications for Drug Listings

 As of last year, FDA requires that drug establishments “certify” listings that have not been changed since the previous calendar year during the annual registration renewal period. In an email to industry this week, FDA stated that manufacturers and repackagers that have not yet incorporated the new product identifier requirements into their labels should not certify that their drug listings are up-to-date during the upcoming registration renewal period (October 1, 2018 to December 31, 2018). Industry should submit a new sampling of the labeling incorporating the product identifier as an update to their listing.

Registrar Corp can provide guidance on FDA’s new product identifier requirements and update drug listings on your behalf. For more information, complete the form below.  You can also reach us by phone at +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day at regstaging.wpengine.com/livehelp.

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*Update: In January 2019, FDA extended the eCTD compliance date for Type III DMFs to May 5, 2020.

Beginning May 5, 2018, the U.S. Food and Drug Administration (FDA) will require electronic common technical document (eCTD) format for all new Drug Master File (DMF) submissions, including reports and amendments.  FDA states that it will reject DMF submissions not in eCTD format following this deadline.

What is eCTD?

eCTD is currently FDA’s standard submission format for new drug applications (NDAs), investigational new drug applications (INDs), abbreviated new drug applications (ANDAs), and certain biologics license applications (BLAs).  FDA states that DMFs are typically submissions to these applications and, as such, are subject to electronic submission required by section 745A(a) of the Federal Food, Drug, and Cosmetic (FD&C) Act.

After the deadline, FDA will require users to submit DMFs in the eCTD version supported by the FDA Data Standards Catalog.  Additionally, an April 2017 FDA guidance document establishes technical specifications for aspects such as submission structure, file formats and versions of submission components, and required locations for datasets and study information.

Existing DMFs that are not in eCTD format, including those in paper form, do not require resubmission; however, additional submissions such as annual reports, supplements, and amendments to these DMFs must be submitted through ESG in eCTD.  Existing paper DMFs voluntarily converted to eCTD will retain their current DMF number.  Companies typically convert their existing paper DMFs to eCTD to expedite the review process of a NDA or ANDA that references the DMF.

How Do I Send an eCTD Submission?

eCTD submissions 10GB or smaller must be sent through FDA’s Electronic Submissions Gateway (ESG).  Prior to accessing ESG, a user must request an application number from FDA, register for an ESG account, and configure their computer to communicate with the gateway.  FDA advises users to perform a series of tests prior to submission.  The process for ESG access may require several weeks.

Alternatively, you can make the process quick and easy by having a Regulatory Specialist, such as Registrar Corp, convert your DMF submissions to eCTD format and submit them to FDA through ESG.  For more information, contact us by phone at +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day: regstaging.wpengine.com/livehelp.

On January 2, 2018, the U.S. Food and Drug Administration (FDA) removed all drug establishments that did not renew their FDA registrations for 2018 from its active registration database. The Agency also removed all uncertified drug product listings from publication.

• FDA removed 1,256 of the 10,496 drug establishments in FDA’s database as of December 31, 2017 (12%)
• FDA removed 30,786 of the 118,255 drugs listed in FDA’s database as of December 31, 2017 (26%)

Companies that would like to verify that their drug establishment registrations or drug product listings are active with FDA can do so at no cost using the following links:

Annual FDA Drug Establishment Registration

FDA requires registered drug establishments to renew their registrations between October 1 and December 31 each year.  Those that fail to renew by the deadline are removed from FDA’s database, and drugs manufactured in unregistered facilities are considered misbranded.  Marketing misbranded drugs in the USA is a prohibited act that may be met with seizure and injunction.

Registrar Corp can verify whether your registration was properly renewed at no cost.  Verify your registration now.

New “Blanket No Change Certification” Requirements for Drug Product Listings

FDA requires drug establishments to report any changes to product listings in June and December each year.  Until recently, unchanged listings required no action.  FDA introduced a change for the 2017 renewal period requiring registered drug establishments to submit a “blanket no change certification” in structured product labeling (SPL) format for all drug listings that required no updates within the year.  Unchanged listings that were not properly certified during the 2017 renewal period were removed from publication, making it a prohibited act for those products to be marketed in the USA.

Registrar Corp can verify whether your listings are currently on file with FDA at no cost.  Verify your listings now.

Registrar Corp is a U.S. FDA consulting firm that helps drug establishments comply with FDA regulations.  Registrar Corp assists with FDA registration, drug product listings, drug labeling, drug master files (DMFs), and more.  For questions or assistance, visit regstaging.wpengine.com, call +1-757-224-0177, or chat with a Regulatory Advisor 24-hours a day at regstaging.wpengine.com/livehelp.

This article was originally published as a press release.

On December 20, 2017, The U.S. Food and Drug Administration (FDA) published a final rule that will prohibit the inclusion of commonly used ingredient triclosan and 23 other active ingredients in antiseptics for health care environments.  Following the rule’s compliance deadline of December 20, 2018, health care antiseptics containing any of the covered ingredients will not be permitted to enter interstate commerce without FDA approval of a new drug application (NDA).  You will find a list of the covered ingredients below.

The scope of this rule only applies to antiseptic products (i.e. washes, scrubs, rubs, and skin preparations) used by health care professionals in health care settings.  Antiseptic products intended for use by consumers are covered by two separate rules, one of which had a compliance deadline in September 2017.

Why are these ingredients prohibited?

The covered ingredients were initially part of a 1994 tentative final monograph for OTC antiseptic drug products.  A 2015 proposed rule called for additional data to support the safety and effectiveness of these ingredients for use in health care antiseptic products.  FDA did not receive any additional data, and the available scientific evidence surrounding the ingredients was insufficient to support a determination that they are generally recognized as safe and effective (GRASE).

FDA is delaying final rulemaking for at least one year on benzalkonium chloride, benzethonium chloride, chloroxylenol, alcohol (also known as ethanol or ethyl alcohol), isopropyl alcohol, and povidone-iodine.  The Agency has stated that a determination for these ingredients will be dependent upon whether ongoing studies are eventually completed, and if so, when they are completed.

Not sure how this rule applies to your health care antiseptics?  Registrar Corp’s Regulatory Specialists can conduct a full review of your antiseptic product’s ingredients and labeling.  We review your product’s active ingredients to ensure that they conform to the requirements specified in the applicable FDA monographs for antimicrobial drug products. We also inspect your labeling to ensure that its content and formatting conform to numerous FDA drug regulations.  In addition to an extensive report of suggested revisions, you will receive a print-ready label incorporating these changes.  For assistance, call us at +1-757-224-0177 or chat with a Regulatory Advisor 24/7 at regstaging.wpengine.com/livehelp.

Ingredients Deemed Not Generally Recognized as Safe and Effective under the Health Care Antiseptic Final Rule: