FDA Works to Reduce Medication Errors, Part Two: Contents of a Complete Submission

April 13, 2016

Additional information on FDA’s guidance is available in our preceding FDA News article entitled “FDA Works to Reduce Medication Errors, Part One: Overview of FDA’s Proprietary Naming Guidance.”

On Wednesday, April 6th, FDA published a guidance, entitled “Contents of a Complete Submission for the Evaluation of Proprietary Names,” in accordance with one of the PDUFA IV performance goals.  The guidance, which is part of the Agency’s initiative aimed at minimizing medication errors, applies to:

Although the guidance covers various topics regarding the evaluation of proposed proprietary names, it places an emphasis on the content requirements for complete submissions.

General Information

FDA states that “each submission should be identified as follows:

  • For proposed proprietary name reviews, include the statement ‘REQUEST FOR PROPRIETARY NAME REVIEW’ in bold, capital letters on the first page of the submission.
  • For amendments to proposed proprietary name reviews, include the statement ‘AMENDMENT TO REQUEST FOR PROPRIETARY NAME REVIEW’ in bold, capital letters on the first page of the submission.
  • For proposed proprietary names that applicants and sponsors are submitting for reconsideration following an initial rejection of their proposed proprietary names, include the statement ‘REQUEST FOR RECONSIDERATION OF PROPRIETARY NAME’ in bold, capital letters on the first page of the submission.”

Proposed proprietary name evaluation submissions for products that are the subject of an IND should include FDA Form 1571; submissions for products that are the subject of an NDA, ANDA, or BLA should include FDA Form 356h.  The information that is provided on the form includes:

  • “Proposed first choice proprietary name
  • Application number (BLA/NDA/ANDA/IND)
  • Applicant or sponsor contact information including the company name, name and title of the contact person, address, phone number, fax number, and e-mail address
  • Identification of the submission as a Request for Proprietary Name Review, Request for Reconsideration of Proprietary Name, or Amendment to a Request for Proprietary Name Review.
  • A list of contents in the submission.”

Proposed Proprietary Name

The guidance outlines the information about the proposed proprietary name that all submissions should contain, including:

  1. Primary & alternative proposed proprietary name
  2. Intended pronunciation of the proposed proprietary name
  3. Derivation of proprietary name
  4. Intended meaning of proprietary name modifiers (e.g. prefix, suffix)
  5. Pharmacologic/therapeutic category

Additional Product Information

In its guidance, FDA describes what a submission should include if the product has proposed labels and labeling, as well as what should be included if the product does not yet have proposed labels and labeling.

If the product does have proposed labels and labeling, both the proposed labeling and the proposed container labels and labeling should be included in the submission.  This includes:

  • Professional labeling (or physician labeling or package insert)
  • Patient package insert (or Medication Guide)
  • Container label
  • Other external labeling or packaging, such as carton labels, pouches or overwraps, and sample labels.

If the proposed container labels and labeling are available, the size of the actual label should be indicated in the submission.  In addition, the label, labeling, and packaging should be provided in color, and should “reflect the presentation that will be used in the marketplace, so that FDA can assess the presentation of the product name and information.  For small container labels and labeling, please provide the original copy and a larger copy for ease of review.”

FDA states that the proposed container labels and other proposed external labeling will be evaluated to identify potential problems that could lead to confusion and cause medication errors.  The guidance provides a number of examples, such as:

  1. “If critical information, such as the drug name and concentration, is not displayed prominently or is masked by more prominent but less critical information, these factors could contribute to confusion and possible medication errors.
  2. If product names are obscured by a logo or are illegible because of the font or color of the text, these factors could lead to name confusion or product selection errors.
  3. The similar appearance of labels or labeling among different drugs or different dosage strengths of drugs could contribute to selection of an incorrect drug or product strength where product names are similar.”

If the product does not yet have proposed labels or labeling, FDA states that the applicant must provide following information, which is normally contained in professional labeling:

  1. Established name
  2. Prescription status
  3. Dosage form(s)
  4. Product strength(s)
  5. Proposed indication(s) for use
  6. Route(s) of administration
  7. Usual dosage, frequency of administration, dosing interval, maximum daily dose
  8. Dosing in specific populations
  9. Instructions for use
  10. Storage requirements
  11. How supplied and packaging configuration

Product Dispensing & Delivery

The following product dispensing and delivery information should be included in all submissions:

  • A list of all likely care environments for dispensing and use of the product, such as “whether the product is expected to be used in an inpatient/hospital setting, long-term care facility, clinic, doctor’s office, or home.”
    • Provides insight into where an error might occur in the medication-use system.
  • The proposed distribution of the product, for example whether the product will be dispensed from a retail or hospital pharmacy, or directly from the manufacturer or select wholesaler.
    • Provides insight into where an error might occur in the medication-use system.
  • A model and instructions for use of the product delivery system or product device (if applicable). If no model is available, a detailed description of the delivery system or device.
    • “Allows FDA to assess actual use of the product and identify possible similarities to a different product with a similar name.”
  • If dispensed with a measuring device (such as a calibrated dosing cup), the device should be included. If it is not available, a description of the device including measuring calibration and any text or graphics to be printed on the device should be included.
    • “Allows FDA to assess whether products with similar names could be subject to product confusion and medication error based on similarities in dosing and administration or in overall appearance.”

Applicant Assessment of Proprietary Name, Packaging, and/or Labeling

Any assessments of the proprietary name, packaging, and/or labeling conducted by the applicant may be included in the submission, but will not act as a substitute for other information described in the guidance as constituting a complete submission.  In addition, if this information is not included, FDA will not consider a submission to be incomplete.

For additional details on the Agency’s recommendations, view the FDA’s full guidance.

Are you developing a FDA-regulated product?  Do you need to prepare an application for submission to FDA?  We can help.  For more information about our services and how we can help you, contact us today.


How to  Compile a Science  Backed NDA Submission Like an Expert Promo Banner

June 18, 2021

How to File Post-Approval Changes to an NDA or ANDA

On November 21, 1997, the Food & Drug Modernization Act (the Modernization Act) was enacted by Congress. Section 116 of the Modernization Act amended the Federal Food, Drug, and Cosmetic (FD&C) Act...

FDA Outlines Policies for Compounding Drug Products That Are Essentially Copies of Approved Drugs Under Section 503B of the FD&C Act

In our preceding FDA News article, we focused on the content of the first draft guidance, which addresses restrictions concerning the compounding of drug products that are essentially copies of...

October 1, 2018

FDA Issues Final Guidance Regarding Content & Format Requirements for ANDA Submissions

On Tuesday, September 25th, the FDA issued a guidance document entitled “ANDA Submissions – Content and Format.” The document, initially issued as a draft guidance in June 2014, provides sponsors...