Drug+Listing+Q&A

[Updated July 7, 2014]

Import Issues:
See Import Q-and-A page.

Subject:
//Relabeler Listings on DailyMed//

Question:
Please check out two different labels for Lipitor on the DailyMed site. One by Parke-Davis (Pfizer), the NDA holder and another by A-S Medication Solutions, LLC (I believe a repackager). Which one is the latest and greatest? Is it possible that you could have multiple versions of Lipitor or any other product on DailyMed? If so, how does the end user, such as a health care practitioner, know which is the most current?

Answer:
The final "Guidance for Industry - Providing Regulatory Submissions in Electronic Format - Drug Establishment Registration and Drug Listing" states that FDA encourages companies to update their listing (including content of labeling) when the changes occur. The repacker and relabeler would have to acquire the drug product manufacturer/distributor's label prior to listing their products and before their SPL listing documents can be submitted, validated, and transmitted to DailyMed.

FDA plans to continue to post the information on DailyMed. The listing (NDCs) information in the repackers and relabelers SPL documents are utilized by several entities and need to be disseminated. SPL is no longer only a labeling document.

Subject:
//Revision Date, Effective Date//

Question:
What should sponsors use as the revision date for the Drug Listing SPL?

Answer:
Now that the SPL can be also a listing document, the revision date should reflect the actual date of the latest revision.

From 21 CFR 201.57: (a)(15)Revision date. The date of the most recent revision of the labeling, identified as such, placed at the end of Highlights. The FDA has specifically used the  field to calculate the revision date in the highlights.

Subject:
//Drug Listing, OTC product with different flavors//

Question:
If multiple over-the-counter products are identical except for their flavor, should they be drug listed separately in SPL? Prior to eList, the products were listed separately using the 2657 form.

Answer:
The preference is for each OTC drug product to be included in its own SPL document. However, this is just a recommendation.

[14-Sept-09: update related to manual override requests]

Subject:
//Drug Listing, R4 override of R3//

Question:
How can I change the package type for SPL that was posted on DailyMed in R3 but is now being filed in R4? How can I 'force' an R4 version SPL to overwrite a R3 version SPL?

Answer:
Some companies are experiencing difficulty identifying the coreID of their submission to request the status of their electronic NDC Labeler Code, Establishment Registration, and drug listing SPL submissions. Therefore, to eliminate some of the confusion and avoid the receipt of the Gateway message ID which results in fruitless searches of our databases, companies should just send the Gateway receipt file. We can locate the coreID in the receipt file.

There is a significant reduction in the amount of information needed to request a manual "override" of SPL documents in the elist system. To request manual "overrides" provide the following data: 1. Gateway coreID [ You do not have to attach the error message from the ESG; The FDA retains a copy of the error message with each file ]. 2. Reason for override request

For speediest reply, companies should submit SPL-related e-mails to the spl@fda.hhs.gov e-mail account __only__.

The process is not automatic. The FDA may respond that an override will not be done. In that case, the sponsor would receive a response with one or more reasons for the override refusal.

Typical response time to requests for manual overrides which are** NOT ** granted is 24 - 48 hours. However, in a few rare cases, the response time may be delayed for up to a week as we attempt to provide the most accurate and informed response.

Subject:
//Drug Listing, DESI products//

Question:
What Marketing Category do you use for a DESI product?

Answer:

 * Use Unapproved other (code = C73627)

Subject:
//Drug Listing, DESI products, Grandfathered products//

Question:
What Marketing Category do you use for a DESI product? What is the marketing category for a prescription product(high strength fluoride)that was "grandfathered in" (pre-1962)- It pre-dates NDA, ANDA, etc., but a marketing category is required for validation, what do we use?

Answer:

 * Use Unapproved other (code = C73627)

Subject:
//Drug Listing, Establishment Registration and D-U-N-S® Number FAQs//

Question:
How do we list APIs or Bulk Ingredients when listing separately?

Answer:

 * For the Content of labeling sections – container/carton label jpeg file; text from principal display panel
 * Packaging ‘as ordered’ – pick one NDC, and the average amount
 * Route of administration is ‘not applicable’
 * Dosage form is ‘powder’
 * DMF numbers are not used as application numbers for APIs – use BULK INGREDIENT as the marketing category; no application number
 * The company that manufactures the API should provide NDC code.

Question:
Can we list APIs or Bulk Ingredients together with Finished Dosage Form Products?

Answer:
CDER has requested that APIs be listed separately.

For CBER and CVM, when an establishment manufactures the API in its drug product it accomplishes the “API listing” by including itself with the operation “API manufacture” in its establishment operation.

Subject:
//Drug Listing, Establishment Registration and D-U-N-S® Number FAQs//

Question:
For Authorized Generics, does Content of Labeling need to be submitted as part of the Drug Listing?

Answer:
Yes

Question:
Is the FEI number equivalent to the D-U-N-S® Number?

Answer:
No, the FDA FEI number is FDA Firm Establishment Identifier which is obtained from the FDA District Office. A D&B® D-U-N-S® Number is a unique nine-digit sequence recognized as the universal standard for identifying and keeping track of over 100 million businesses worldwide. This number is issued by Dun and Bradstreet.

Reference(s) :
//For information on D-U-N-S®, please// //go to// [|//http://www.dnb.com/US/index.asp//] For FAQs on //D-U-N-S®, please// //go to// DUNS Number FAQ

Question:
Why use the D-U-N-S® Number? Wouldn't the FEI number provide the same benefit as the D-U-N-S® Number?

Answer:
The FEI is an internal (FDA) number, rather than a cross-agency number, so communication would be limited. Additionally, the DUNS number provides an extra level of validation (external checking)

Question:
Do sites outside the US need a D-U-N-S® Number as well?

Answer:
Yes. There are additional contact numbers at Dun & Bradstreet specifically for overseas companies.

Question:
API Suppliers are often a separate entity from the sponsor; who is responsible for obtaining D-U-N-S® Number?

Answer:
The API Suppliers are responsible for obtaining their own D-U-N-S® Number.

Question:
How would imported pro ducts such as an Active Pharmaceutical Ingredient (API) and Bulk Formulation be submitted since these products have no labeling.

Answer:
An SPL document should be generated and submitted to the OC via the eGateway as they were prior to SPL. The content of labeling section would be left blank and the drug listing would be entered along with a copy of the representative label used during shipping.

Question:
Suppliers of finished product usually begins prior to the approval of a product. These products would be considered APIs. How would product be shipped?

Answer:
Manufacturers of these products will need to drug list similarly to the paper process. When drug listing the API, the content of labeling will be blank and the label and drug listing information will need to be included.

Question:
Would API and Bulks products be posted on the daily meds? Would products for export only or DEA controlled substances where product is not marketed in the US need to be listed?

Question:
How will content of labeling be handled by multiple companies including both manufact and wholesalers?

Answer:
The labeler is the company that owns the NDC label. The registrant can be the labeler or manufacturer. When drug listing, the labeler will usually be the registrant and will enter their information and leave the registrant field blank unless the registrant is a private label distributor. Then the two fields will be different. For multiple companies, the DUNS number of each company will be entered into the establishment field. If the product that is being sourced is taken from commercial distribution and there is already an NDC number available for this product, no DUNS number is needed.

Where is the NDC number entered?
 * Follow up Question:.**

**Question:**
What is a significant change in the label. There is a descrepancy between companies as some submit every change to the labeling and others only submit Changes Being Effected (CBE) and Prior Approvals. There are many other variations on the defininition of significant change. What kind of label changes require updates to drug listing.

Answer:
A material change does not include changes to color or display. Editorial changes do not need updates to the drug listing. All drug listing will be displayed on the DailyMeds Website so it will be up to the company to submit when it wants to have a product listed. Only a representative sample of the labeling will be needed and not all of the labeling for a given product.

Reference(s) :
//For more information on, please// //go see// § 207.3(a)(3) at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=207.3

**Question:**
How do we list samples since they are not currently in SPL?

Answer:
Samples currently are listed and have their own NDC number and the new SPL process will mirror the paper process. Samples will be included in the drug listing section of the product SPL.

**Question:**
How will products be registered? Will this be integrated with the application?

Answer:
Drug listing will go to the Agency as a separate submission through the eGateway to the Office of the Commisioner. The SPL file used in a drug listing submission will be the file posted to DailyMeds. No Form 356h is required since this is not part of the eCTD. SPL release 4 that is submitted to the application will no longer be posted on DailyMeds.

**Question:**
How will the representative sampling of labels be submitted with a product drug listing?

Answer:
Components for the representative sample of labeling can go in a JPEG format in the SPL document.

Question:
Do all Labeler codes need to be submitted at one time?

Answer:
A company can choose to do a labeler code if they do not want to do all of them at one time. Once the company chooses to submit this labeler code electronically, it must continue to submit the updates electronically. But it does not have to submit all at one time.

Question:
How does a product get loaded onto DailyMeds?

Answer:
Each product will be loaded on the eGateway as an SPL Release 4 file. Products will be submitted to the OC rather than CDER/CBER/CDRH/etc. The Electronic Document Room will extract the file where it will go into FDA's ELIST system and then get posted onto DailyMeds.


 * Process flow for paper vs. electronic**

**Question:**
What happens if a sponsor Drug Lists first, and then submits a Changes Being Effected via the Application route (for review by Review Division)?

Answer:
This sequence of filing would be acceptable.

**Question:**
What happens if a sponsor Drug Lists and then does **not** submit a Changes Being Effected via the Application route (for review by Review Division)?

Answer:
This is a regulatory issue, as sponsors are required to submit a Changes Being Effected for applicable labeling changes [Insert reference to CFR section]

**Question:**
What happens if a sponsor submits a Changes Being Effected via the Application route (for review by Review Division) but does **not** Drug List?

Answer:
The updated label would not be posted on DailyMed for public access, nor would any changes to the Drug Listing be reflected in the appropriate FDA databases.

[Nov 24, 2008]

Question:
//What do I enter in the Product Status field?//

Answer:
//If the product is currently on the market, use ACTIVE. If the product has been discontinued or withdrawn, use COMPLETED and include the product expiry date.//

Reference(s) :
DIA Meeting, October 29-30, 2008

[Nov 24, 2008]

Question:
//What do I enter in the Marketing Date field?//

Answer:
//Use the date when the label should be released to DailyMed.// //If a product has been on the market already, include a date less than or equal to today's date.//

Reference(s) :
DIA Meeting, October 29-30, 2008

[08-Dec-2008]

Subject:
//NDC Code on inner package or packaging//

Question:
If a package has an NDC code on the inner package, and no NDC code on the outer package, where does the NDC go in the SPL?

Answer:
The NDC code from the inner package is placed with the outer package data.

Reference(s) :
DIA Meeting, October 29-30, 2008

[08-Dec-2008]

Subject:
//NDC Code on inner package and on outer package or packaging//

Question:
If a package has an NDC code on the inner package, and a different NDC code on the outer package, where do the NDCs go in the SPL?

Answer:
Include both the NDC code from the inner package and the NDC code for the outer package.

Reference(s) :
DIA Meeting, October 29-30, 2008

[08-Dec-2008]

Subject:
//SPL Product Image//

Question:
Is the SPL Product Image the same as a diagram or picture of the product provided by a company?

Answer:
No. The SPL Product Image is used for a different kind of image. See SPL Product Image page for more information

Reference(s) :
DIA Meeting, October 29-30, 2008

[08-Dec-2008]

Subject:
//Header or Title or Both//

Question:
What is in the Header? Can I have a Title in the Header? Will the stylesheet create a title for me? What company sponsor or organization is included in the header?

Answer:
The SPL Stylesheet currently provides a product title that is build from the Proprietary Name element + NonProprietary Name element + Route of Administration Additionally, a sponsor can include a Title element that contains free-text. The sponsor company or organization listed as the distributor or label sponsor is listed after the product title in parentheses or square brackets.

Reference(s) :
DIA Meeting, October 29-30, 2008