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FDA Warns Against Failure to Pay Drug User Fees



August 29, 2014 by David Lennarz

Before August 2014, a total of only five companies had ever received warning letters from the U.S. Food and Drug Administration (FDA) regarding failure to pay generic drug user fees. On August 7, 2014, FDA added three additional companies to its list of non-compliers: Colgate, Explora Laboratories, and Korea United Pharm. The FDA warning letters to the companies state:

“Any drugs or active pharmaceutical ingredients (API) manufactured, prepared, propagated, compounded, or processed at a facility for which required facility fees have not been paid or required self-identifying information has not been submitted, or drugs containing an active pharmaceutical ingredient manufactured, prepared, propagated, compounded, or processed at such a facility are misbranded. 21 U.S.C. §§ 352(aa), 379j-42(g)(4)(A)(iii). It is a violation of federal law to ship misbranded products in interstate commerce, which includes causing such products to be imported into the United States. 21 U.S.C. § 331(a). Such violations can result in injunctions or seizures of the misbranded products. See 21 U.S.C. §§ 332 and 334. Products that appear to be misbranded may also be denied entry into the United States. 21 U.S.C. § 381(a)(3).”

FDA also warned the non-paying companies that any new generic drug submissions referencing those companies would not be received if they did not pay the fees within twenty days.

Registrar Corp is an FDA consulting firm that helps companies comply with FDA regulations. If you receive an FDA warning letter or have questions about FDA drug regulations, Registrar Corp can assist you. Call us at 1-757-224-0177 or receive online Live Help 24 hours a day from our regulatory specialists at http://www.registrarcorp.com/livehelp.

         

FDA Extends UDI Compliance Date for Lenses



August 22, 2014 by David Lennarz

The U.S. Food and Drug Administration (FDA) granted a one year extension of the Unique Device Identifier (UDI) labeling requirements compliance date for most contact and intraocular lens labelers.  The FDA’s final rule regarding the Unique Device Identification System states that class III medical devices must comply to UDI labeling requirements by September 24, 2014, but the compliance date is now September 24, 2015 for the following class III devices (product codes are in bold):

  • Rigid Gas Permeable Contact Lenses (extended wear)  MWL
  • Orthokeratology Contact Lenses (overnight)  NUU
  • Soft (hydrolic) Contact Lenses (extended wear)  LPM
  • Intraocular lens (IOL)  HQL
  • Multifocal Intraocular Lens  MFK
  • Accommodative Intraocular Lens  NAA
  • Toric Optics Intraocular Lens  MJP
  • Phakic Intraocular Lens  MTA
  • Iris Reconstruction Lens   NIZ

FDA extended the compliance period because of the enormous amount of Global Unique Device Identification Database (GUDID) submissions that will result from lens labelers, and because many of these submissions will be nearly identical. The extension gives FDA time to work with lens labelers to develop an efficient approach to getting the information into the GUDID.

For any questions about FDA UDI regulations, contact Registrar Corp at 1-757-224-0177 or receive online Live Help from our regulatory specialists: http://www.registrarcorp.com/livehelp.

         

FDA Unique Device System 101: The Basics



August 21, 2014 by David Lennarz

Last September, the U.S. Food and Drug Administration (FDA) published a final rule regarding the new Unique Device System which requires all domestic and foreign medical devices distributed in the U.S. to have a Unique Device Identifier (UDI). With the first of many compliance dates for the new rule quickly approaching, Registrar Corp decided to share with you the need-to-know basics of UDI regulations.

What is a UDI?

A UDI is a numeric or alphanumeric code that consists of two parts: a device identifier (DI) and a production identifier (PI).  The DI is fixed and mandatory for all UDIs. It identifies the labeler and the specific version or model of a device.  The PI is a conditional, variable portion of a UDI that identifies one or more of the following if included on the label:

  • The lot or batch number
  • The serial number
  • The expiration date
  • The date manufactured
  • The distinct identification code for a human cell, tissue, or cellular and tissue-based product (HCT/P) regulated as a device

Class I devices are not required to bear the PI portion of a UDI.

Who creates a UDI?

FDA requires that UDIs be created by accredited issuing agencies. As of now, there are three FDA-accredited agencies to choose from: GS1 in New Jersey, HIBCC in Arizona, and ICCBBA in California. There may be more options in the future, as FDA is accepting applications from companies seeking to obtain accreditation.

Where are UDIs placed?

A UDI must be placed on the device label and on the device packages. If the device is intended to be used more than once and reprocessed between uses, the UDI should also be placed on the device itself. The UDI must be placed in two formats: human readable (plain text) and machine readable (AIDC).

Who places a UDI?

The labeler of a device places a UDI. A labeler is the person who applies or modifies the label of a device with the intent that the device will be commercially distributed in the U.S. without any other alterations to the labeling.

Does the labeler have other responsibilities?

Yes. The labeler of a device with a UDI is responsible for submitting information about the device to the Global Unique Device Identification Database (GUDID), a public database that contains important identification information about every device with a UDI.

Labelers are also responsible for determining whether a certain change to a device creates a new version or model of the device, because different versions and models of devices require different DIs.

When is the compliance date for UDI regulations?

Compliance dates depend on a device’s classification. This compliance date chart is directly from the FDA guidance.

FDA, UDI

Compliance Dates for FDA UDI Requirements

 Are there any exceptions to the UDI requirements?

Class I devices are entirely exempt from UDI requirements if FDA has exempted them from the good manufacturing requirements of 21 CFR 820.  Class I devices that contain a Universal Product Code (UPC) on their labeling and packages are deemed to meet all UDI labeling requirements, but the labelers of such devices are still required to submit data to the GUDID. Other general exemptions include, but are not limited to:

  • Devices used solely for research, teaching, or chemical analysis and not intended for clinical use
  • Individual, single-use devices distributed in single packaging
  • Custom and investigational devices
  • Veterinary devices not intended for man
  • Devices held by the National Strategic Stockpile

 I still have questions. What do I do?

Registrar Corp is an FDA consulting firm that helps companies comply with FDA regulations. We can answer any further questions about UDI requirements and help you determine how the new UDI regulations affect your product in particular. Just call us at 1-757-224-0177, Tweet us @RegistrarCorp, or receive online Live Help from our regulatory specialists 24 hours a day at http://www.registrarcorp.com/livehelp.

         

Before this summer, the U.S. Food and Drug Administration (FDA) already had the authority to detain potentially adulterated or misbranded tobacco, food, and medical devices encountered during inspections.  That authority has now been expanded to include drugs.  On June 30, 2014, a new final rule issued by FDA became effective that enables the agency to detain drugs encountered during inspections that FDA inspectors have reason to believe are adulterated or misbranded.  The purpose of the rule is to prevent drugs that are non-compliant with FDA regulation from being distributed and used throughout the U.S. while FDA considers what actions to take concerning the drugs and, if necessary, as the agency initiates legal action.

During the detention period, drugs detained by FDA may not be used, altered, tampered with, or moved from the place they were detained unless approved by the FDA representative who issued the detention order.  If a detained drug is not in its final form for shipment, it may also be moved in order to be put in final form.  In this case, the person responsible for moving the drug must separate it from other drugs and orally notify the FDA representative who issued the detention order of its movement.

The new final rule requires FDA to issue a detention notice to the owner, operator, or agent of the place where a drug is detained as quickly as possible once the decision to detain a drug is made.  If the owner or user of a detained drug is a different individual than the owner, operator, or agent of the place, FDA must notify them as well.  Anyone who is issued a detention notice will also be notified when the detention is terminated by the responsible FDA representative or when the detention expires, whichever occurs first.

Under most circumstances, detention periods may not exceed 20 calendar days after a detention order is issued, but the FDA District Director of the district where a detained drug is located may add 10 days to a detention period if he or she determines it will take longer to consider or follow through with necessary actions regarding the detained drug.

Having products detained can be a frustrating experience.  It can disappoint clients and can cost a company a significant amount of money due to lost sales and the costs of bringing a product into compliance.  Foreign companies exporting drugs to the U.S. should be aware of this new rule, seeing as 40 percent of finished drugs and the majority of active ingredients come from overseas.  Under The Generic Drug User Fee Amendments of 2012 (GDUFA), FDA is increasing the amount of foreign drug manufacturer inspections. By FY 2017, FDA inspections of foreign drug manufacturers are to be nearly equal to the amount of inspections of domestic drug manufacturers, which have been required to be inspected every two years.

Registrar Corp’s Drug Labeling and Ingredient Review service can help companies ensure their products meet FDA requirements.  Our regulatory specialists will review your product labeling against the Code of Federal Regulations, FDA issued warning letters, and more, and provide revised labeling for those products that may be marketed in the US.  Registrar Corp is an FDA consulting firm that helps companies comply with FDA regulation. If you have any questions about FDA drug regulation, contact Registrar Corp at 1-757-224-0177 or receive online Live Help from our regulatory specialists: http://www.registrarcorp.com/livehelp.

         

New FDA API Reveals Annual Increase in Drug Recalls



August 20, 2014 by David Lennarz

On August 18, 2014, the U.S. Food and Drug Administration (FDA) announced on their official blog the release of a drug labeling application programming interface (API) on openFDA, an online database made available to the public in June 2014. The new API offers statistics regarding drug labeling and enforcement, like the number of drug label submissions each year and the breakdown of who reports adverse events.

In the context of the drug labeling API, an adverse event refers to when a person experiences an undesirable response associated with the use of a prescription or over-the-counter drug, such as a serious side effect or poor product quality. Those experiences can be submitted to FDA through an adverse event report. According to the new API, the number of annual adverse drug event reports has increased substantially in ten years. In January 2004, 12,978 adverse drug events were reported to FDA. In January 2013, the number of reports was 81,588. Not surprisingly then, the number of FDA monitored drug product recalls has risen substantially as well. In January 2004 there were 17 drug recalls. In January 2013 there were 383.

Labeling and manufacturing violations of FDA requirements account for 21% of drug product recalls. In the blog, FDA’s Chief Health Informatics Officer Taha A. Kass-Hout referred to approved drug labeling as a “living document” because, even after approval, labels need to be updated as new information about the safety and effectiveness of a drug unfolds.

“In some cases, the approved labeling for a prescription drug can be extensive, consisting of 20,000 words or more,” Kass-Hout said in the blog. “It can be a daunting task to study more than one labeling to better understand a class of drugs, or to compare drugs, and to keep up with their regular changes.”

Classifying a drug and ensuring a label contains all required elements can be difficult. Registrar Corp’s Labeling and Ingredient Review Service helps drug companies determine the likely classification of their products and helps ensure their drug labeling is in compliance with FDA requirements. For more information about FDA drug regulation, contact Registrar Corp at 1-757-224-0177 or receive online Live Help from our regulatory specialists: http://www.registrarcorp.com/livehelp.

See the FDA blog here.

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