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FDA EXTENDS DEADLINE FOR MANDATORY USE OF eCTD FORMAT FOR TYPE III DMF SUBMISSIONS.

On April 25, 2018, the U.S. Food and Drug Administration (FDA) extended the deadline for the mandatory use of electronic common technical document (eCTD) format for type III Drug Master File (DMF) submissions by one year. eCTD format will now be required for type III DMF submissions beginning May 5, 2019.

Type II, type IV, and type V DMF submissions to FDA must be in eCTD format beginning May 5, 2018. Additionally, FDA recommends using eCTD format to file Type III DMF submissions despite the extension.  eCTD submissions must be filed through FDA’s Electronic Submissions Gateway (ESG).  The process to obtain access to ESG can take several weeks, so it is prudent for businesses to begin working toward compliance as soon as possible.

You can make compliance easy by having Registrar Corp manage your DMF submissions.  Our Regulatory Specialists use FDA’s ESG to submit new DMFs to FDA in eCTD format as well as convert existing DMFs to eCTD to make future updates, reports, and amendments easier. If you are not certain if your DMFs qualify for the extension, Registrar Corp can verify your classifications at no cost.

For more information, contact us by phone at +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day: www.registrarcorp.com/livehelp.

Drug Establishments Must Use eCTD Format for U.S. FDA Drug Master File (DMF) Submissions Beginning May 5, 2018

*Update: In April 2018, FDA extended the eCTD compliance date for Type III DMFs to May 5, 2019.


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: www.registrarcorp.com/livehelp.

FDA Removes Expired Drug Establishment Registrations and Uncertified Listings from its Database

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 www.registrarcorp.com, call +1-757-224-0177, or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp.

This article was originally published as a press release.

2017 in Review – U.S. FDA Medical Device and Drug Regulations

The medical device and drug industries saw numerous regulatory developments in 2017.  The U.S. Food and Drug Administration (FDA) introduced new requirements, fees, deadline extensions, and exemptions.  Below, Registrar Corp provides an overview of regulatory highlights this year.

FDA Removed Medical Device and Drug Establishments that Did Not Register for 2017

Medical device and drug establishments that failed to properly renew their registrations for 2017 were removed from FDA’s active registration database. The Agency will likely do the same in 2018.  Marketing medical devices and drugs without a valid registration is a prohibited act that may be met with seizure and injunction.

FDA Extended the UDI Compliance Date for Class I Devices to 2020

FDA issued a letter in June announcing its intention to extend the universal device identifier (UDI) compliance dates for class I and unclassified devices.  The letter proposes to push the UDI labeling compliance date for these devices to September 24, 2020.

FDA Exempted Certain Class II Devices from 510k

In July, FDA exempted certain class II medical devices from premarket notification (510k) requirements. The exempt devices “are sufficiently well understood and do not present risks that require premarket notification review to provide a reasonable assurance of safety and effectiveness.”  View a list of the exempt devices here.

The Compliance Date Passed for the Consumer Antiseptic Wash Final Rule

As of September, over-the-counter (OTC) consumer antiseptic washes containing any of nineteen certain ingredients are not permitted to enter interstate commerce without approval of a new drug application (NDA).  FDA made this determination after discovering there was insufficient evidence to support the ingredients’ safety and effectiveness for their intended use.

FDA Published FY 2018 User Fees for Medical Devices and Generic Drugs

The Medical Device User Fee Amendments (MDUFA) and Generic Drug User Fee Amendments (GDUFA) were reauthorized for fiscal year (FY) 2018.  The amendments introduced differences in rates from FY 2017, as well as new types of fees for certain facilities and submissions.

View the list of fees for medical device establishments here.

View the list of fees for drug establishments here.

FDA Introduced a New Verification Requirement for U.S. Agents of Medical Device Establishments

The U.S. Agent of medical device establishments located outside of the United States is now required to confirm this role with FDA.  Agents must accept their designation through the FDA Unified Registration and Listing System (FURLS).  If the Agent does not respond to a verification email within ten days, the establishment will need to designate a new Agent.

FDA Introduced Annual Certification Requirement for Unchanged Drug Listings

The 2017 registration renewal period introduced a requirement for drug establishments to submit a “blanket no-change” certification for drug listings that did not receive any changes to data or labeling during the year.  Certifications must be submitted in structured product labeling (SPL) format.

FDA Published Final Guidance for UDI Direct Marking Requirements

In November, FDA issued a final guidance to clarify a device labeler’s responsibilities for UDI direct marking requirements.  Class II devices must comply with direct marking requirements by September 24, 2018.  During a December webinar, FDA stated that they do not intend to enforce these requirements for class I and unclassified devices until September 24, 2022.

FDA Issued a Final Rule on the Safety and Effectiveness of Triclosan in Health Care Antiseptics

FDA finalized a rule prohibiting the use of Triclosan and 23 other active ingredients in OTC antiseptics for health care environments.  After December 20, 2018, health care antiseptics containing these ingredients will not be permitted to enter interstate commerce without FDA approval of an NDA.

As we cross into 2018, Registrar Corp will continue to keep the medical device and drug industries informed about important FDA regulations.  For assistance with FDA requirements in either industry, call us at +1-757-224-0177, or chat with a Regulatory Advisor 24/7 at www.registrarcorp.com/livehelp.

FDA Issues Final Rule on Safety and Effectiveness of Triclosan in Health Care Antiseptics

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 www.registrarcorp.com/livehelp.

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

Chlorhexidine gluconate
Mercufenol chloride
Cloflucarban
Methylbenzethonium chloride
Fluorosalan
Phenol
Hexachlorophene
Secondary amyltricresols
Hexylresorcinol
Sodium oxychlorosene
Iodophors (Iodine-containing ingredients)
• Iodine complex (ammonium ether sulfate and polyoxyethylene sorbitan monolaurate)
• Iodine complex (phosphate ester of alkylaryloxy polyethylene glycol)
• Iodine tincture USP
• Iodine topical solution USP
• Nonylphenoxypoly (ethyleneoxy) ethanoliodine
• Poloxamer—iodine complex
• Undecoylium chloride iodine complex
Tribromsalan
Triclocarban
Triclosan
Triple dye
Combination of calomel, oxyquinoline benzoate, triethanolamine, and phenol derivative
Combination of mercufenol chloride and secondary amyltricresols in 50 percent alcohol

FDA Announces New Enforcement Approach to Drugs Labeled as Homeopathic

Once small and specialized, homeopathic drugs now comprise a nearly $3 billion industry.  Following an increase in reported health concerns stemming from these products and a flurry of unsubstantiated health claims surrounding the industry, the U.S. Food and Drug Administration (FDA) is taking new measures to curb the widespread distribution of potentially harmful drugs labeled as homeopathic.

What are Homeopathic Drugs?

Homeopathy is a form of alternative medicine based on the principle of remedying health conditions using diluted solutions of substances that produce similar symptoms in a healthy patient.

The Food, Drug, and Cosmetic (FD&C) Act defines articles recognized in the official Homeopathic Pharmacopoeia of the United States as drugs.  FDA states that homeopathic drugs “are subject to the same requirements related to approval, adulteration and misbranding as any other drug product.”

Despite this, the uniqueness of homeopathic drugs delayed them from the 1972 over-the-counter (OTC) drug review, which determined the safety and effectiveness of most OTC drugs on the U.S. market.  Even now, FDA has not conducted a formal review of homeopathic drugs.  Since 1988, a FDA Compliance Policy Guide (CPG) establishes provisions under which these products may be marketed without the prior FDA approval required of other drug products.

Why is FDA Cracking Down on Homeopathic Drugs?

Numerous homeopathic drugs contain potentially harmful ingredients.  As recently as September 2017, a homeopathic drug facility received a Warning Letter, citing failure to establish adequate in-process controls for products containing multiple potentially toxic ingredients.  One such ingredient was Nux vomica, a plant bearing constituents commonly used for rat poison.

Throughout 2017, FDA issued at least four additional letters to homeopathic drug manufacturers who failed to adequately test and control potentially toxic substances in their products.  FDA charged the drugs in question as adulterated.

New Enforcement Approaches to Homeopathic Drugs

In addition to FDA, the U.S. Federal Trade Commission (FTC) has issued measures to mitigate the prevalence of unsubstantiated health claims made by homeopathic drug manufacturers. A 2016 FTC Enforcement Policy Statement requires homeopathic drug labeling to communicate that “there is no scientific evidence that the product works.”  The label must also indicate that “the product’s claims are based only on theories of homeopathy from the 1700s that are not accepted by most modern medical experts.”

A December 2017 FDA draft guidance explains that the Agency intends to prioritize enforcement on products that are known to cause harm to patients, including those with reported health issues and those deemed adulterated under section 501 of the FD&C Act.

FDA states it will also focus increased attention on homeopathic drugs with less overt health concerns.  According to the guidance, unapproved drugs intended to treat serious or life-threatening conditions may cause a patient to delay or discontinue treatment already generally recognized as safe and effective (GRASE). Homeopathic drugs designed for vulnerable populations (e.g. infants and the elderly) may pose significant health risks even in small concentrations, in spite of treatments that have already been determined GRASE.  For this reason, these drug categories may see increased regulatory enforcement.

In the previously referenced Warning Letters, FDA maintains that “nothing in the FD&C Act exempts homeopathic drugs from any of the requirements related to adulteration, labeling, misbranding, or approval.”  The letters and newly issued guidance suggest that FDA intends to expand efforts to hold homeopathic drug manufacturers accountable to the regulations derived from the FD&C Act.

Registrar Corp is a consulting firm that assists drug companies with U.S. FDA regulations.  Our Regulatory Specialists can assist with FDA registration and drug listing, labeling requirements, and other drug regulations.  For assistance or questions call +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.

FDA Introduces Annual Certification Requirement for Unchanged Drug Product Listings 

Drug establishments registered with the U.S. Food and Drug Administration (FDA) are required to renew their registrations with every year between October 1 and December 31.  The 2017 renewal period marks the first time that registered establishments must submit a “blanket no change certification” for all drug product listings that required no updates within the year.

FDA requires drug establishments to report any changes to product listings in June and December each year.  Until recently, unchanged listings required no action.  This year, registrants must certify that all product listings which were not updated have had no changes occur to the data or labeling.  Product listings that are neither updated within the year nor certified during the renewal period may be considered expired by FDA and removed from the Agency’s database.  Marketing unlisted drugs in the United States is a prohibited act.

How can I obtain “blanket no change certification” for my drug product listings?

Registered drug establishments should submit a “Blanket No Change Notification” for all products that have not been updated during the current year to certify there were no changes to the data or labeling as part of their annual registration renewal.  The notification must be submitted in structured product labeling (SPL) format.  Structuring data in SPL format requires SPL authoring software.  The SPL files can be submitted to FDA via the Agency’s Electronic Submission Gateway (ESG).  Users may also use CDERDirect to submit for human drug listings.  According to FDA, all SPL listing submissions will undergo a rigorous set of validation rules.

Registrar Corp can renew your FDA registration and certify or update your drug product listings using the required SPL format on your behalf.  Our Regulatory Specialists are experienced in navigating FDA’s ESG and can complete your renewal quickly and properly.  Contact us at +1-757-224-0177 or chat with a Regulatory Advisor online 24-hours a day at www.registrarcorp.com/livehelp.

Medical Device and Drug Establishments Must Renew FDA Registrations by December 31, 2017

Medical device and drug establishments that produce and distribute products for sale within the United States are required to renew their U.S. Food and Drug Administration (FDA) registration annually.  Registrar Corp writes to remind the industries that registrations must be renewed for 2018 between October 1, 2017 and December 31, 2017.

Medical device establishments are required to designate an Official Correspondent for FDA communications in their registrations, while drug establishments must designate a Registrant Contact. Additionally, FDA requires all businesses located outside of the United States to appoint U.S. Agents.

Notices for Medical Device Establishments

While there are no major changes this year for drug establishments, medical device businesses should be aware of two important updates for their 2018 renewals:

  1. The 2018 user fee for medical device establishment registration is $4,624, a steep increase of $1242 from 2017. All medical device establishments that are required to register must pay this fee, regardless of whether or not they qualify as a small business for other medical device user fees.
  2. As mentioned previously, foreign medical device establishments are required to designate U.S. Agents in their registrations. The 2018 renewal period marks the first time that designated U.S. Agents must verify their agreement to serve this function.  Once an Agent’s information is entered into the FDA Unified Registration and Listing System (FURLS), the system will issue them a verification email.  Agents will have ten days accept their designation through FURLS.  If a device establishment’s U.S. Agent does not accept, a new Agent must be designated or the registration may be considered invalid for 2018.

Why Timely Renewal is Important

Failure to renew FDA registration can have adverse effects.  In the past, FDA has removed establishments from its database that did not renew, rendering their registration invalid.

FDA may issue a Warning Letter to a medical device or drug business that manufactures and distributes products for interstate commerce without a valid registration.  Shipments from foreign businesses may be denied entry into the United States if their registrations are not renewed.  It is prudent for businesses to complete timely registration renewal to help avoid preventable delays from costly detentions or other enforcement actions.

Registrar Corp can assist in the renewal of your medical device or drug establishment registration, facilitate payment of fees with FDA, and issue a third-party certificate that verifies your registration. Additionally, Registrar Corp can serve as your Official Correspondent or Registrant Contact and U.S. Agent.

Renew a Medical Device Establishment Registration here.

Renew a Drug Establishment Registration here.

Alternatively, you can call us at +1-757-224-0177 or you can chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.

FDA Publishes FY 2018 User Fees for Medical Devices and Generic Drugs

The Medical Device User Fee Amendments (MDUFA) and the Generic Drug User Fee Amendments (GDUFA) were reauthorized on August 18, 2017 to be in effect through September 30, 2022.  The U.S. Food and Drug Administration (FDA) recently published the Fiscal Year (FY) 2018 fees for both MDUFA and GDUFA, introducing new types of fees and changes in rates from FY 2017.  All MDUFA and GDUFA fees begin on October 1, 2017.  To prepare medical device and drug businesses for these requirements, Registrar Corp outlines some notable changes to these amendments this year.

Fees for medical device establishments:

MDUFA requires a user fee from medical device establishments that register with FDA, as well as fees for certain applications, notifications, and other types of submissions filed on or after October 1, 2017.  Small businesses, defined for this regulation as having less than $100 million in gross sales during the most recent tax year, are eligible for reduced rates on most fees.  All other facilities are subject to a standard fee.  Some significant changes to MDUFA for this fiscal year are explained below.

Annual Establishment Registration – All medical device establishments that are required to register with FDA must pay the Annual Establishment Registration user fee.  The fee for this year is $4,624 (a $1,242 increase from FY 2017).  Unlike with other MDUFA fees, there is no waiver or reduction for small businesses.

510(k) Application – The standard fee for 510(k) applications sees an increase of $5,876 from the FY 2017 rate of $4,690 to $10,566.  Small businesses are required to pay $2642, facing an increase of $297 from the previous year.

De Novo Classification Application – New to the recent reauthorization of MDUFA is a fee for De Novo Classification applications.  A standard business that files an application following the start of FY 2018 is required to pay $93,229, while a small business pays $23,307.

Refer to the chart below for a detailed comparison of MDUFA’s fee changes between FY 2017 and FY 2018.

 

FY 2018 MDUFA Fees

Fee Type 2017 2018
Annual Establishment Registration $3,382 $4,624
Application Fees Standard Small Business Standard Small Business
510(k) $4,690 $2,345 $10,566 $2,642
513(g) $3,166 $1,583 $4,195 $2,098
De Novo Classification N/A N/A $93,229 $23,307
PMA, PDP, PMR, BLA $234,495 $58,624 $310,764 $77,691
panel-track supplement $175,871 $43,968 $233,073 $58,268
180-day supplement $35,174 $8,794 $46,615 $11,654
real-time supplement $16,415 $4,104 $21,753 $5,438
BLA efficacy supplement $234,495 $58,624 $310,764 $77,691
PMA annual report $8,207 $2,052 $10,877 $2,719
30-day-notice $3,752 $1,876 $4,972 $2,486

 

Fees for drug establishments:

GDUFA requires user fees for certain drug establishments producing active pharmaceutical ingredients (API) or finished dosage forms (FDF), the submission of certain drug master files (DMF) for generic drug products, and the submission of certain applications for generic human drug products.  New additions to GDUFA include abbreviated new drug application (ANDA) program fees and contract manufacturing organization (CMO) facility fees.  Some significant changes to GDUFA for this fiscal year are explained below.

Contract Manufacturing Organization Fees – For the recent GDUFA reauthorization, CMO facility fees apply to FDF facilities that are identified in at least one approved ANDA, but are not the ANDA holder or an owner or affiliate of the holder.  These fees are a two-thirds reduction of FDF facility fees for qualifying establishments.  Domestic CMOs are required to pay a user fee of $70,362, while foreign CMOs pay $85,362.

ANDA User Fees – The user fee for the submission of a single abbreviated new drug application (ANDA) has increased from $70,480 to $171,823.

ANDA Program Fees – Businesses holding ANDAs are now required to pay a user fee in relation to how many they hold.  The smallest ANDA program, with as little as one approved ANDA, begins with a user fee of $159,079.  A business holding between six and nineteen approved ANDAs is required to pay a medium program fee of $636,317. The largest program fee for businesses holding twenty or more approved ANDAs is $1,590,792.

Refer to the chart below for a detailed comparison of GDUFA’s fee changes between FY 2017 and FY 2018.

 

FY 2018 GDUFA Fees

Fee Type 2017 2018
Facility Fees Domestic Foreign Domestic Foreign
API $44,234 $59,234 $45,367 $60,367
FDF $258,646 $273,646 $211,087 $226,087
CMO N/A N/A $70,362 $85,362
ANDA Program Fees – Based upon the number of approved ANDAs held
Large (20 or more ANDAs) N/A $1,590,792
Medium (6 – 19 ANDAs) N/A $636,317
Small (5 or fewer ANDAs) N/A $159,079
Application Fees
ANDA $70,480 $171,823
Type II DMF $51,140 $47,829

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

Compliance Date Passed for Consumer Antiseptic Wash Final Rule

September 6th, 2017 marked the compliance date for the U.S. Food and Drug Administration’s (FDA) Consumer Antiseptic Wash Final Rule.  As of this date, over-the-counter (OTC) antiseptic washes containing any of nineteen active ingredients deemed by FDA as not “generally recognized as safe and effective” (GRASE) are not permitted to be introduced into interstate commerce without approval of a new drug application (NDA).  The rule applies to antiseptic washes intended to be used with water and does not cover products such as wipes or hand sanitizers.  Soaps, hand washes, and body washes containing these ingredients that are currently in retail establishments do not require removal, but new batches of these products may not enter the market.  You will find the list of affected ingredients below.

Why are these ingredients not GRASE?

Before the September 6 compliance date, products containing the nineteen affected ingredients were able to be marketed without approval of an NDA.  The ingredients were part of a 1994 tentative final monograph for OTC antiseptic drug products.

In 2013, FDA published a proposed rule to amend the 1994 monograph.  The Agency stated that further review of the data revealed the monograph did not sufficiently account for the health risks associated with repeated, long-term exposure to these ingredients and risks were greater than previously thought.  According to FDA, long-term exposure can have hormonal effects and can lead to the development of bacterial resistance.  In terms of effectiveness, FDA determined there was insufficient evidence that using products containing the covered ingredients was more beneficial than using products used for a comparable purpose with lower health risk (i.e. non-antibacterial soap and water).  Due to these findings, FDA deemed these nineteen ingredients “not generally recognized as safe and effective” for this intended use.

FDA has not yet made a determination on three additional active ingredients: benzalkonium chloride, benzethonium chloride, and chloroxylenol.  In March of 2017, FDA granted an additional year for interested parties to conduct studies providing further data that would support the safety and effectiveness of these ingredients.  Products using these ingredients may currently be introduced into the market, and FDA states that it may extend this time period if studies yield adequate progress.

Not sure how this rule affects your products?  Registrar Corp’s Regulatory Specialists can help determine how FDA regulates your specific antiseptic wash products and review your labeling for compliance.  For questions or assistance, call us at +1-757-224-0177. Alternatively you can chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.

Ingredients Deemed Not Generally Recognized as Safe and Effective under the Consumer Antiseptic Wash Final Rule:

Cloflucarban
Methylbenzethonium chloride
Fluorosalan
Phenol (greater than 1.5 percent)
Hexachlorophene
Phenol (less than 1.5 percent)
Hexylresorcinol
Secondary amyltricresols
Iodophors (Iodine containing ingredients)
• Iodine complex (ammonium ether sulfate and polyoxyethylene sorbitan monolaurate)
• Iodine complex (phosphate ester of alkylaryloxy polyethylene glycol)
• Nonylphenoxypoly (ethyleneoxy) ethanoliodine
• Poloxamer—iodine complex
• Povidone-iodine 5 to 10 percent
• Undecoylium chloride iodine complex
Sodium oxychlorosene
Tribromsalan
Triclocarban
Triclosan
Triple dye