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A Year in Review: FDA Drug and Device Regulations in 2016

Registrar Corp keeps industry up-to-date on regulations throughout the year. In 2016, the U.S. Food and Drug Administration (FDA) proposed several new regulations, including label submission requirements for certain devices, and issued extensions for compliance deadlines.

Here’s a compilation of the happenings for the drug and device industries in 2016.

  • February 18: FDA removed 771 drug facilities from the registration database due to failure to complete their annual registration renewal for 2016.
  • August 1: FDA published its annual user fees for medical devices and generic drugs for fiscal year 2017 (October 1, 2016 through September 30, 2017).
  • September 8: FDA issued a UDI compliance extension for certain Class II devices.
  • September 24, 2016: This marked the Unique Device Identifier (UDI) compliance date for Class II devices. Read here for tips on UDI compliance.
  • October 20: FDA proposed to require label submissions for Class II and Class III home-use devices.
  • December 21: FDA banned the use of powdered medical gloves due to the substantial risk of illness or injury to both patients and medical professionals.

In addition to the various FDA extensions, proposals, and final rules that were released over the last year, the Federal Trade Commission (FTC) issued new labeling disclaimers for homeopathic drugs.

Registrar Corp is looking forward to the new year and continuing developments in FDA regulation of the drug and device industries. For any questions about FDA drug and device regulations, contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp.

 

FTC Requiring New Labeling Disclaimers for Homeopathic Drugs

The Federal Trade Commission (FTC) recently announced a new enforcement policy for homeopathic drugs. The policy requires homeopathic drug packaging to display the following disclaimers in cases where marketers cannot adequately substantiate their claims:

  1. There is no scientific evidence that the product works.
  2. The product’s claims are based only on theories of homeopathy from the 1700s that are not accepted by most modern medical experts

The FTC issued the enforcement policy after releasing a 24-page report that contained public comments and findings from commissioned studies. The report concluded that “customers were likely to be deceived by labels that did not carry the appropriate disclaimers.”

Prior to the new policy, homeopathic drugs were not required to prove their effectiveness or abide by U.S. Food and Drug Administration (FDA) regulations for other types of drug products. Despite being deemed by the FTC as having “no scientific evidence” to support effectiveness, homeopathic drugs have avoided regulation due to the nature of homeopathy. Homeopathy is built on the belief that small doses of substances that cause symptoms in healthy people can cure similar symptoms in unhealthy people. FDA defines a homeopathic drug as “any drug labeled as being homeopathic which is listed in the Homeopathic Pharmacopeia of the United States (HPUS), an addendum to it, or its supplements.” Homeopathic drug potencies consist of substances that are diluted from 1/10 to 1/50,000 or higher.

FDA has been considering changes to homeopathic drug regulations since 2014 due to homeopathy growing into a multimillion dollar industry in the United States. In addition to the growth of the industry, homeopathic drugs have been seen to cause adverse effects on consumers.  A 2012 report showed there were 10,311 poison exposure cases related to “homeopathic agents”.  In August 2015, the FTC recommended that FDA reevaluate its regulatory framework for the regulation of homeopathic drugs after FTC research found that a significant number of consumers don’t understand:

  • Homeopathy or homeopathic products
  • How homeopathic products are regulated
  • The level of scientific evidence supporting homeopathic claims

Registrar Corp is an FDA consulting firm that helps drug companies understand and comply with FDA regulations.  For any questions about changes to homeopathic drug regulations or other current FDA regulations for drug companies, contact Registrar Corp at +1-757-224-0177 or speak with a Regulatory Advisor 24 hours a day through Live Help.

FDA issues Final Rule on the Removal of Triclosan and Triclocarban from Antibacterial Soaps

On September 6, 2016, the U.S. Food and Drug Administration (FDA) issued a final rule on the effectiveness and safety of over-the-counter (OTC) antibacterial soaps. This final rule affects consumer antiseptic wash products for both hands and body which contain the frequently used ingredients triclosan and triclocarban as well as 17 other active ingredients (See 81 FR 61110 for a full list of eligible ingredients).  Beginning September 6, 2017, companies that manufacture and market affected antibacterial soaps may not legally introduce or deliver for introduction their products into interstate commerce unless approved under a new drug application.

FDA first proposed this rule in 2013 after research suggested that long-term use and exposure to specific active ingredients used in antibacterial soaps may cause a health risk to consumers. Examples of these health risks include hormonal effects and bacterial resistance.   According to Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER), “Consumers may think antibacterial washes are more effective at preventing the spread of germs, but we have no scientific evidence that they are any better than plain soap and water.”

FDA has postponed a rule making decision for consumer antiseptic soaps and washes that contain the ingredients- benzalkonium chloride, benzethonium chloride, and cloroxylenol (PCMX) for one year to allow industry to provide additional safety information. FDA will take regulatory action at that time, dependent upon whether the data provided by industry supports the conclusion that those active ingredients are generally recognized as safe and effective for this intended use.

FDA’s final rule only applies to consumer rinse-off antibacterial soaps.  This final rule does not affect consumer no-rinse handnitizers or antibacterial products used in hospital or health care settings.

Registrar Corp can help manufacturers determine whether their product is affected by FDA’s final rule.  For questions or assistance with the compliance of the final rule on antibacterial soaps, contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.come/livehelp.

 

FDA Publishes FY 2017 User Fees for Devices and Generic Drugs

The U.S. Food and Drug Administration (FDA) published its annual user fees for medical devices and generic drugs for fiscal year 2017 (October 1, 2016 through September 30, 2017).

Medical Device User Fees for FY 2017

  • Establishment Registration Fee: $3,382 (No Reduction for Small Businesses)
  • Premarket Application (PMA, BLA, PDP): $234,495 / $58,624 for Small Businesses
  • Premarket Notification (510(k)): $4,690 / $ 2,345 for Small Businesses
  • 513(g) request for classification information: $3,166 / $1,583 for Small Businesses
  • PMA Annual Report: $8,207 / $2,052 for Small Businesses

FDA’s FY 2017 medical device user fees show a decrease from FY 2016.

Registrar Corp can register medical device establishments with U.S. FDA as well as review a 510(k) for compliance with submission requirements.

Generic Drug User Fees for FY 2017

Application Fees:

  • Abbreviated New Drug Application (ANDA): $70,480
  • Prior Approval Supplement (PAS) to an ANDA: $35,240
  • Drug Master File (DMF): $51,140

Facility Fees:

  • Active Pharmaceutical Ingredient (API)—Domestic: $44,234
  • API—Foreign: $59,234
  • Finished Dosage Form (FDF)—Domestic: $258,646
  • FDF—Foreign: $273,646

FDA’s FY 2017 ANDA and PAS application fees show a decrease from FY 2016.   The FY 2017 DMF application fee as well as the API and FDF facility fees show an increase from FY 2016.

Registrar Corp can register a drug establishment and file DMFs with U.S. FDA.

Filing in ACE for FDA: Compliance Dates and Common Errors

On June 9, 2016, the U.S. Customs and Border Protection (CBP) hosted a webinar on filing import entries through the Automated Commercial Environment (ACE) portal.  The webinar was organized by the U.S. Food and Drug Administration (FDA) and the National Customs Brokers and Forwarders Association of America (NCBFAA).

What is ACE?

Customs brokers and self-filing importers must file information with CBP and other agencies regarding products they import into the United States. CBP describes ACE as “the primary system through which the trade community will report imports and exports and the government will determine admissibility.” CBP and FDA, along with 46 other government agencies, have partnered to make ACE a single window for submitting all data required by the agencies.  ACE will replace ACS, the current commercial database used to submit data through CPB to FDA.

Compliance Dates

June 15, 2016 is the date when ACE is to become the sole filing system for the following FDA entry types:

  • 01 – Consumption – Free and Dutiable
  • 03 – Consumption – Antidumping/Countervailing Duty
  • 06 – Consumption – Foreign Trade Zone (FTZ)
  • 11 – Informal – Free and Dutiable
  • 23 – Temporary Importation Bond (TIB)
  • 51 – Defense Contract Administration Service Region (DCASR)
  • 52 – Government – Dutiable

While June 15 acts as the mandatory filing date for these FDA entry types, CBP is allowing a sort of learning period through July 23, 2016.  Entries filed through ACS after June 15 will likely be allowed, but the consequences will be decided on a case-by-case basis.  Users may receive a warning message.  CBP may also follow up with ACS filers to see why they are not filing through ACE and to determine how CBP can assist in the transition to ACE.  Come July 23, ACS will no longer be allowed as an alternate filing method.

Common Errors when Filing in ACE

During the webinar, FDA revealed some of the most common errors and causes for entry rejection made when filing entries through ACE.

  • Filers must provide a valid prior notice confirmation number for food and beverage shipments. Filers should only include the confirmation number and not the other FDA data required to file prior notice. Many filers submit invalid prior notice confirmation numbers.
  • Many filers fail to provide a valid FDA registration number. (Tip: FDA requires food facilities to renew their FDA registration between October 1 and December 31 of each even-numbered year. Registrations not renewed as required are considered expired by FDA.)
  • Many entries are rejected for a missing or invalid product code, affirmation of compliance code, or intended use code.
  • Many filers include mismatching entity IDs. For example, an entry for a processed food must list a manufacturer code (as opposed to a grower code) as the entity ID.
  • Many filers include mismatching source type codes. Entries for imports from growers or consolidators must list a country of growth, while entries for imports from manufacturers of processed foods must list a country ofproduction. Both types of entries must also include a country of shipment.
  • Many filers list a foreign country as the ultimate consignee for non-food items. This is incorrect, as the ultimate consignee is meant to represent the final destination where the product will be delivered within the United States.

These are but a few of the mistakes made when filing entries within ACE.  FDA offers assistance with ACE entries at[email protected]. FDA ACE support will be available 24/7 beginning sometime this month.  FDA also provides this chart for identifying required data elements for entries of FDA-regualated products.

If you notice a mistake in an ACE entry, you may submit corrections up to 5 days before a shipment’s expected arrival to the United States.  Once the shipment is within 5 days of its expected arrival, no corrections may be made unless FDA rejects the entry.

Speeding Up Your Imports

It’s prudent for brokers and importers to begin filing their entries through ACE as early as possible, as ACE provides the quickest entry. According to FDA, the agency is actively prioritizing ACE entries over those filed through ACS.  Entries filed through ACE are processed two times faster.

While DUNS and FEI numbers are not currently required for filing entries of most commodities in ACE, FDA noted that including this data may expedite the processing of an entry.  “Providing a DUNS number gives FDA a higher confidence level in looking at that data,” the agency said during the webinar regarding confirming the name and address of a product manufacturer.

How Registrar Corp can Assist

Registrar Corp offers a variety of services to help brokers obtain the information they need to file entries in ACE.  Registrar Corp can:

Registrar Corp’s FDA Compliance Monitor also acts as a valuable resource for custom brokers and importers.  The monitor provides detailed information on monitor facilities, such as a facility’s DUNS number (when available) and any FDA Warning Letters, Import Alerts, Import Refusals, and Inspection Classifications tied to the facility.

For more information on filing FDA-regulated entries in ACE, regulations for importing FDA-regulated products to the United States, or how Registrar Corp can assist, contact +1-757-224-0177.  Live help is available 24-hours a day at www.registrarcorp.com/livehelp.

FDA Discusses Upcoming DMF Electronic Filing Requirements

On February 4, 2016, the U.S. Food and Drug Administration (FDA) hosted a webinar regarding upcoming electronic filing requirements for Drug Master Files (DMFs).  FDA will require DMFs, as well as other pharmaceutical applications, to be filed in electronic common technical document (eCTD) format beginning May 5, 2017. Any paper submissions filed on or after this date will be subject to rejection. There will be no waivers or exemptions for submitting DMFs in eCTD.

FDA Drug & Device Regulations in 2015: A Year in Review

FDA Drug & Device Regulations (2015)

In 2015, the drug and medical device industries saw a turn toward digital. The U.S. Food and Drug Administration (FDA) established new regulations requiring certain documents to be submitted electronically, including pharmaceutical product applications and adverse event reports for devices. FDA also opened an online database for the public to obtain information about devices.

Read below to learn about these and other points of progress in FDA’s regulation of the drug and device industries in 2015.

Click here for Registrar Corp’s review of FDA food industry regulations in 2015.

Outsourcing Facilities Must Register and Report Drug Products to FDA by December 31

[:en]Outsourcing facilities must complete their annual registration with the U.S. Food and Drug Administration (FDA) between October 1 and December 31, 2015. The fee to register for fiscal year 2016 is $16,465.  The fee for small businesses is $5,203.

Outsourcing facilities must also submit drug product reports to FDA between December 1 and 31, 2015, for all drugs produced in the preceding 6-month period (June 1 through November 30, 2015). The report must include the following for each compounded drug:

  • The active ingredient and strength of active ingredient per unit
  • The source of the active ingredient (bulk or finished drug)
  • The National Drug Code (NDC) number of the source drug or bulk active ingredient, if available
  • The dosage form and route of administration
  • The package description
  • The number of individual units produced
  • The NDC number of the final product, if assigned

Outsourcing facilities must submit drug product reports upon registering with FDA and then annually in June and December.  Usually FDA requires that drug product reports be submitted electronically in Structured Product Labeling (SPL) format unless granted a waiver.  However, for the June 2015 reporting period, FDA asked outsourcing facilities to email their reports to FDA in an Excel spreadsheet due to a technical issue with the agency’s electronic reporting system.  It is unclear at this time whether FDA’s electronic reporting system will be prepared to accept submissions in December 2015.  We will keep industry updated.

Registrar Corp can submit drug product reports to FDA, whether in spreadsheet form or SPL format, quickly and properly.  Registrar Corp can also register outsourcing facilities with FDA and facilitate payment of the necessary fees.  For assistance, contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp.

For more information about registration, fees, and reporting requirements for outsourcing facilities, click here.[:es]Outsourcing facilities must complete their annual registration with the U.S. Food and Drug Administration (FDA) between October 1 and December 31, 2015. The fee to register for fiscal year 2016 is $16,465.  The fee for small businesses is $5,203.

Outsourcing facilities must also submit drug product reports to FDA between December 1 and 31, 2015, for all drugs produced in the preceding 6-month period (June 1 through November 30, 2015). The report must include the following for each compounded drug:

  • The active ingredient and strength of active ingredient per unit
  • The source of the active ingredient (bulk or finished drug)
  • The National Drug Code (NDC) number of the source drug or bulk active ingredient, if available
  • The dosage form and route of administration
  • The package description
  • The number of individual units produced
  • The NDC number of the final product, if assigned

Outsourcing facilities must submit drug product reports upon registering with FDA and then annually in June and December.  Usually FDA requires that drug product reports be submitted electronically in Structured Product Labeling (SPL) format unless granted a waiver.  However, for the June 2015 reporting period, FDA asked outsourcing facilities to email their reports to FDA in an Excel spreadsheet due to a technical issue with the agency’s electronic reporting system.  It is unclear at this time whether FDA’s electronic reporting system will be prepared to accept submissions in December 2015.  We will keep industry updated.

Registrar Corp can submit drug product reports to FDA, whether in spreadsheet form or SPL format, quickly and properly.  Registrar Corp can also register outsourcing facilities with FDA and facilitate payment of the necessary fees.  For assistance, contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp.

For more information about registration, fees, and reporting requirements for outsourcing facilities, click here.

FTC Wants FDA to Change How it Regulates Homeopathic Drugs

In August 2015, the Federal Trade Commission (FTC) recommended that the U.S. Food and Drug Administration (FDA) reconsider its regulatory framework for homeopathic medicines. FTC’s recommendation was in response to FDA’s April 2015 request for comments on the matter.

Unlike most other drug products, homeopathic drugs do not have to be reviewed for safety and efficacy or approved by FDA before they may be marketed in the United States.  According to FTC, FDA’s current regulatory framework “may conflict with the Commission’s advertising substantiation policy in ways that may harm consumers and create confusion for advertisers.”

A significant point of conflict between FTC and FDA regulations are requirements for substantiation of claims.  The FTC Act requires companies to have a reasonable basis for making a claim that a product can treat a specific condition as well as competent scientific evidence for health, safety, or efficacy claims.  FDA requires homeopathic drug labels to include an indication for use, but does not require proof of efficacy for the intended use.  FDA also does not require homeopathic drug manufacturers to provide substantiation for health claims included on their labeling.   FTC offered three potential approaches to eliminate this conflict:

  • FDA could hold homeopathic drugs to the same regulatory standards as other drug products.
  • FDA could stop requiring homeopathic drugs to display an intended use.  In this scenario, homeopathic drug manufacturers could still choose to include an intended use, but would be required to provide proof of efficacy in order to comply with FTC regulations.
  • FDA could itself require homeopathic drug manufactures to provide substantiation for intended use claims.

FTC is also concerned that FDA’s current regulatory framework for homeopathic drugs may harm and deceive consumers.  FTC has found that many consumers have incorrect and incomplete ideas of homeopathic drugs, which sit on store shelves next to non-homeopathic drug products.  Research by FTC shows that a significant number of consumers don’t understand:

  • Homeopathy or homeopathic products
  • How homeopathic products are regulated
  • The level of scientific evidence supporting homeopathic claims

These concerns are what have led FTC to recommend that FDA change its regulatory framework.  For more information on homeopathic drugs and other stakeholder opinions on FDA’s current regulatory framework, click here. Registrar Corp stays up-to-date on U.S. FDA regulations and will update industry as FDA’s decision on how to regulate homeopathic drugs progresses.

While homeopathic drugs are not currently required to undergo review and approval by FDA, they are still subject to other FDA regulations for drug products, such as registration and listing requirements.  For information or assistance with current FDA regulations for drug products, contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp.





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