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FDA Requires Electronic Submission of Veterinary Master Files Beginning October 1, 2018

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.

Registrar Corp’s FDA Compliance Monitor Now Includes Recalls

Registrar Corp added recalls to their FDA Compliance Monitor.  Users can now view the recall history of their own company, their suppliers, and potential suppliers, including:

  • The description of the recalled product.
  • The recall classification (the level of health risk involved).
  • The reason for the recall.
  • The current status of the recall (ongoing, completed, etc.).

This capability will help businesses comply with the Food Safety Modernization Act (FSMA), which requires food facilities and US importers to monitor their food suppliers’ FDA compliance as related to food safety. Recalls can damage a brand’s reputation, disrupt supply chains, and delay production and are an important aspect of a facility’s compliance history.

In addition to recalls, the FDA Compliance Monitor includes the FDA inspection history, FDA import alert status, FDA warning letter history, and record of FDA-refused shipments for monitored facilities, making full compliance with FSMA’s monitoring requirements easier than ever before. Schedule a demo of the FDA Compliance Monitor now.

Users can access the FDA Compliance Monitor through MyFDA.com, a simple online portal that makes it easy for food and beverage businesses to manage their FDA compliance, including FDA registrations and prior notice submissions.

For more information about the FDA Compliance Monitor or FSVP monitoring requirements, contact Registrar Corp by phone at +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day: regstaging.wpengine.com/livehelp.

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

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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FDA Publishes FY 2019 Medical Device and Generic Drug User Fees

The U.S. Food and Drug Administration (FDA) recently published the Fiscal Year (FY) 2019 fee schedules for the Generic Drug User Fee Amendments (GDUFA) and Medical Device User Fee Amendments (MDUFA). FY 2019 rates for both amendments take effect on October 1, 2018. To keep industry updated on these requirements, Registrar Corp outlines upcoming changes to these fees below.

Fees for Drug Facilities
GDUFA requires user fees from certain types of drug facilities. On October 1, 2018, generic drug facilities are required to pay any applicable facility fees to FDA. Additionally, GDUFA requires fees for new Type II Drug Master File (DMF) and Abbreviated New Drug Application (ANDA) submissions to FDA. You will find a table of these fees below.

Notable Changes to GDUFA in FY 2019

  • ANDA Program Fees – In FY 2018, FDA introduced program fees for ANDA holders. These facilities pay a user fee based on the number of approved ANDAs they hold on October 1 of a given year.  The FY 2019 ANDA program fees reflect an approximate 17% increase from the previous year.
  • Type II DMF Submission Fees – In FY 2018, the fee for a single Type II DMF submission to FDA was $47,829. FY 2019 will see an approximate 15% increase to $55,013.

You can view a comparison between the FY 2018 and FY 2019 GDUFA fees below:

FY 2019 GDUFA Fees

Fee Type 2018 2019
Facility Fees Domestic Foreign Domestic Foreign
Active Pharmaceutical Ingredient (API) $45,367 $60,367 $44,226 $59,226
Finished Dosage Form (FDF) $211,087 $226,087 $211,305 $226,305
Contract Manufacturing Organization (CMO) $70,362 $85,362 $70,435 $85,435
ANDA Program Fees – Based upon the number of approved ANDAs held
Large (20 or more ANDAs) $1,590,792 $1,862,167
Medium (6 – 19 ANDAs) $636,317 $744,867
Small (5 or fewer ANDAs) $159,079 $186,217
Application Fees
ANDA $171,823 $178,799
Type II DMF $47,829 $55,013

Fees for Medical Device Establishments
MDUFA requires all FDA-registered establishments to pay a user fee during their annual registration renewal. The FY 2019 establishment registration fee for all establishments is $4,884.  According to the publication of MDUFA fees, FDA does not recognize an establishment as legally registered until this fee is paid.

Additionally, MDUFA requires fees for the submission of certain medical device applications to FDA.  Small businesses, defined by MDUFA as having gross sales or receipts of no more than $100 million during the most recent tax year, may qualify for discounts to application fees. All medical device application fees reflect an approximate 3-4% increase from the previous year.

You can view a comparison between the FY 2018 and FY 2019 MDUFA fees below:

FY 2019 MDUFA Fees

Fee Type 2018 2019
Annual Establishment Registration $4,624 $4,884
Application Fees Standard Small Business Standard Small Business
510(k) $10,566 $2,642 $10,953 $2,738
513(g) $4,195 $2,098 $4,349 $2,175
De Novo Classification $93,229 $23,307 $96,644 $24,161
PMA, PDP, PMR, BLA $310,764 $77,691 $322,147 $80,537
panel-track supplement $233,073 $58,268 $241,610 $60,403
180-day supplement $46,615 $11,654 $48,322 $12,081
real-time supplement $21,753 $5,438 $22,550 $5,638
BLA efficacy supplement $310,764 $77,691 $322,147 $80,537
PMA annual report $10,877 $2,719 $11,275 $2,819

Not sure which fees you may be subject to?  Registrar Corp’s Regulatory Specialists can help determine your applicable fees and facilitate payment with FDA.  Call us at +1-757-224-0177, or chat with a Regulatory Advisor 24 hours a day at regstaging.wpengine.com/livehelp.

The Current Implementation Status of FSMA: What’s Required Now, What’s Next, and FDA’s Enforcement to Date

The U.S. Food and Drug Administration (FDA) has finalized a number of rules under the Food Safety Modernization Act (FSMA) that address topics such as:

  • Preventive controls for human and animal food
  • Foreign supplier verification programs
  • Prevention of intentional adulteration of the food supply
  • The registration of food facilities

Many of the deadlines for complying with FSMA rules have already passed. There are also multiple upcoming deadlines that covered businesses should be aware of. A summary of several important FSMA requirements and deadlines may be found below.

Rules On Preventive Controls For Human and Animal Food

Preventive Controls Overview
Under this rule, food facilities are required to establish a hazard analysis and risk-based preventive controls plan (HARPC), also known as a food safety plan, that identifies and analyzes potential hazards and specifies risk-based preventive controls that minimize or prevent identified hazards. Each HARPC plan must be developed by a Preventive Controls Qualified Individual (PCQI), defined as “someone who has successfully completed certain training in the development and application of risk-based preventive controls or is otherwise qualified through job experience to develop and apply a food safety system (FDA.gov),” and must be kept in the records of a given food facility.

Preventive Controls Deadlines
Different businesses face different deadlines for completing their HARPC plan. Compliance deadlines for most businesses have already passed. Very small businesses, defined as businesses with under 1 million dollars in average annual sales of human food or under 2.5 million dollars of average annual sales of animal food and businesses subject to the Pasteurized Milk Ordinance have until September 17, 2018 to comply. Generally, facilities that manufacture, process, pack, or store human or animal food for U.S. consumption are legally required or will soon be legally required to comply with this rule.

Preventive Controls Enforcement and Requirements
Most U.S. food importers must verify that their suppliers meet applicable FDA food safety requirements, including these Preventive Controls requirements. Therefore, a US importer may ask to review a supplier’s HARPC plan. In the event of an inspection, FDA is also likely to review a facility’s written HARPC plan.

Because developing a written HARPC plan is a complex and potentially time consuming endeavor, it is prudent for food businesses to begin developing their plans as soon as possible. It may also be prudent for businesses to seek assistance from professionals with specialized training in FDA regulatory compliance in order to ensure that their plans meet government standards. Registrar Corp’s Food Safety Specialists are PCQIs and can develop or review a facility’s HARPC plan for FDA compliance.

Rule On Foreign Supplier Verification Programs

Foreign Supplier Verification Program Overview
Under the Foreign Supplier Verification Program (FSVP) rule, U.S. importers must have a written FSVP that is developed by a qualified individual and documents that they have completed risk-based activities meant to verify that the food they import into the United States is produced in a manner that is consistent with U.S. safety standards. Among other things, FSVPs must include an analysis of hazards associated with imported products and their suppliers and a plan for conducting verification activities, such as annual supplier audits, testing and sampling imported products, or reviewing a supplier’s HARPC Food Safety Plan. As part of the supplier analysis, importers must monitor and document the FDA compliance status of each of their suppliers by tracking FDA warning letters, import alerts relating to food safety, and other FDA enforcement actions.

Foreign Supplier Verification Program Deadlines
Importers’ deadlines are based on factors such as the size of a foreign supplier, the nature of the importer, and whether the foreign supplier must meet various regulatory requirements. The deadlines for complying with this rule passed for most importers in May 2017 and March 2018. The deadlines for other importers are scheduled to occur on dates ranging from July 26, 2018 to July 27, 2020.

Foreign Supplier Verification Program Enforcement and Compliance
FDA has begun inspecting importers for FSVP compliance. In 2017, failure to develop an FSVP was cited by FDA 108 times. FSVP inspections are based upon a review of records. Though such inspections may take place at an importer’s place of business, FDA may also ask that an importer provide FSVP records electronically or by some other remote means that quickly delivers records to the agency.

Registrar Corp’s Food Safety Specialists can develop new FSVPs on behalf of importers or review existing FSVPs for compliance. Registrar Corp also offers a tool to assist with the supplier monitoring aspects of FSVP.  In order to monitor supplier compliance on their own, an importer would need to routinely search each individual FDA database for each of their foreign suppliers. In order to make this process easier, Registrar Corp developed the FDA Compliance Monitor.  Users simply submit the facility they would like to monitor and the FDA Compliance Monitor will reveal any FDA Import Alerts, Warning Letters, Import Refusals, Recalls, or Inspection Classifications related to the facility. Printable reports allow users to document the compliance of their monitored facilities per FDA’s requirements.

Rule For Mitigation Strategies To Protect Food Against Intentional Adulteration

Intentional Adulteration Overview
Under this rule, most food facilities that are required to register with FDA must develop and implement a written Food Defense Plan for human foods manufactured, processed, packed, or held at the facility. Food Defense Plans should identify vulnerabilities and actionable process steps, mitigation strategies, and procedures for food defense monitoring, corrective actions and verification.

Intentional Adulteration Deadlines
Most covered facilities must comply with FDA’s Intentional Adulteration rule by May 27, 2019.  Small businesses (defined as businesses with fewer than 500 full-time equivalent employees) have one additional year to comply. If you are unsure of whether your business qualifies as small, you can read Registrar Corp’s earlier blog post on how FSMA defines small businesses.  Very small businesses (businesses with less than $10,000,000 in average annual revenue) are exempt from most requirements under FDA’s Intentional Adulteration rule. In order to take advantage of this exemption, businesses must provide records to FDA proving their very small business status by May 27, 2021.

Registrar Corp’s Food Safety Specialists can develop or review a Food Defense Plan for compliance with FDA’s Intentional Adulteration rule.

Amendments to the FDA Registration Process

FSMA made significant changes to the FDA registration process. Food facilities are now required to provide an email address for registration and must assure that FDA will be permitted to inspect the facility under circumstances permitted by the Federal Food, Drug and Cosmetic Act.

Additionally, FSMA requires facilities to renew their FDA registrations during each even numbered year. For example, because 2018 is even numbered, food facilities will have to renew their registration later this year between October 1 and December 31. It is very important that facilities comply with renewal requirements. In 2017, FDA removed 28% of food facility registrations from its database. Many of these removals resulted from a failure to properly renew registration as was required in 2016.

Registrar Corp’s Regulatory Specialists can help facilities register or renew their registrations with FDA quickly and properly.

Responding to the Implementation of FSMA

FSMA imposes many complex requirements on food businesses. The deadlines for complying with these various requirements have already passed or will soon pass. Businesses should take measures to ensure that they are in compliance. One such measure would be to enlist the help of Registrar Corp’s Regulatory Specialists who have expert knowledge of FSMA and extensive experience in helping businesses comply with FDA regulations. For more information, call +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day at regstaging.wpengine.com/livehelp.

U.S. FDA Permits 8 Additional Non-Digestible Carbohydrates To Be Declared As Dietary Fibers

In a recent guidance document, the U.S. Food and Drug Administration (FDA) announced the intention to permit eight isolated or synthetic non-digestible carbohydrates to be declared as dietary fiber on the nutrition facts label.  Pending rulemaking, FDA intends to exercise enforcement discretion when the following are included in a label’s dietary fiber declaration:

  • Mixed plant cell wall fibers
  • Arabinoxylan
  • Alginate
  • Inulin and inulin-type fructans
  • High amylose starch (resistant starch 2)
  • Galactooligosaccharide
  • Polydextrose
  • Resistant maltodextrin/dextrin

Why Is FDA Permitting These Fibers?

Prior to publication of the 2016 Revision of the Nutrition and Supplement Facts Label Final Rule, existing FDA regulations did not define “dietary fiber.”  Under the revised rule, isolated or synthetic non-digestible carbohydrates may only be included in dietary fiber declarations if FDA determines them to have “physiological benefits.”  The final rule named seven isolated or synthetic fibers that met this requirement:

  • Beta-glucan soluble fiber
  • Psyllium husk
  • Cellulose
  • Guar gum
  • Pectin
  • Locust bean gum
  • Hydroxypropylmethylcellulose

After reviewing petitions and scientific literature surrounding twenty-six isolated or synthetic non-digestible carbohydrates, FDA determined that the eight additional fibers demonstrate the required physiological benefits.

How Does This Affect My Label?

Industry previously expressed concern that FDA’s new definition for dietary fiber would exclude fibers they were already declaring on their labels, limiting their ability to make certain nutrient content or health claims.  For example, in order for many foods to say they are a “good source of fiber,” “contain fiber,” or “provide fiber,” their fiber content must be between 10 and 19 percent (2.8 g – 5.32 g) of the daily reference value (28 g) per reference amount customarily consumed (RACC).  FDA’s inclusion of the above fibers will allow more manufacturers to continue to make fiber claims under updated label requirements.

When Do I Need To Comply?

Changes to the dietary fiber declaration take effect following the compliance deadline for FDA’s new label rules.  Food manufacturers grossing $10 million or more in annual food sales have until January 1, 2020 to update their label for compliance with FDA’s new regulations.  Businesses grossing less than $10 million are provided an additional year.

Start compliance now for a smooth transition.  Registrar Corp can review your food labeling for compliance with new U.S. FDA regulations.  In addition to a report of recommended changes, you will receive a print-ready graphic file of your revised label.  For more information, call +1-757-224-0177 or chat with a Regulatory Advisor 24/7 at regstaging.wpengine.com/livehelp.