Questions+from+August+29+Process+Call

[26-Aug-2009] =Process/Communication Forum Discussion, August 26 [2009]=

Subject:
**Electronically delisting NDCs/products using SPL**

Question:
Q: For products that are filed only in paper format, do they still need to be delisted via electronic filing? Are they ‘automatically delisted’ after a few years?

Answer:
 Right now, there is no ‘automatic delisting’. The NDC codes will remain in the DRLS files.

Reference(s) :
//(per Q&A with FDA on August 29, 2009 at Process / Communication Forum)//

Question:
Q: What if the labeler code no longer exists (was never submitted electronically)?

Answer:
 You have to submit the Labeler Code Request first, then list electronically, then delist electronically.

//(per Q&A with FDA on August 29, 2009 at Process / Communication Forum)//
 * Reference(s) :**

Question:
Q: If you’ve already submitted the delisting through the spreadsheet, do you have to resubmit via the SPL route?

Answer:
 If it was already submitted, you don’t have to resubmit.

//(per Q&A with FDA on August 29, 2009 at Process / Communication Forum)// 
 * Reference(s) :**

Subject:
Multiple SPLs - same actives & presentations, different NDC codes.

**Question:**
If you have two SPLs, each with different NDCs, for the same active ingredient, can they both be up on DailyMed?

Answer:
//Yes. Remember that if you keep marketing the product, you have to continue keeping the labeling up-to-date - and that involves both SPLs//

Reference(s) :
//(per Q&A with FDA on August 29, 2009 at Process / Communication Forum)//

 · __There’s no longer the capability to send a spreadsheet with the delist information. __ <span style="font-size: 11pt; color: black; font-family: Symbol; msofareastfontfamily: Symbol; msobidifontfamily: Symbol; msolist: Ignore; mso-fareast-font-family: Symbol; mso-fareast-language: EN-US; mso-bidi-font-family: Symbol; msofareastlanguage: EN-US;">· <span style="font-size: 11pt; color: black; font-family: Arial; mso-fareast-font-family: 'Times New Roman'; mso-fareast-language: EN-US;">For delisting an entire product, you must now submit an SPL, including a marketing end date for the product. <span style="font-size: 11pt; color: black; font-family: Symbol; msofareastfontfamily: Symbol; msobidifontfamily: Symbol; msolist: Ignore; mso-fareast-font-family: Symbol; mso-fareast-language: EN-US; mso-bidi-font-family: Symbol; msofareastlanguage: EN-US;">· <span style="font-size: 11pt; color: black; font-family: Arial; mso-fareast-font-family: 'Times New Roman'; mso-fareast-language: EN-US;">Submit the SPL file, include all the NDCs. Immediately submit the SPL again, with an end marketing date for the NDCs that need to be de-listed. <span style="font-size: 11pt; color: black; font-family: Symbol; msofareastfontfamily: Symbol; msobidifontfamily: Symbol; msolist: Ignore; mso-fareast-font-family: Symbol; mso-fareast-language: EN-US; mso-bidi-font-family: Symbol; msofareastlanguage: EN-US;">· <span style="font-size: 11pt; color: black; font-family: Arial; mso-fareast-font-family: 'Times New Roman'; mso-fareast-language: EN-US;">If we need to change the product code portion of the NDC, creating a new NDC code, it can be filed without needing to delist the previous NDC code. <span style="font-size: 11pt; color: black; font-family: Symbol; msofareastfontfamily: Symbol; msobidifontfamily: Symbol; msolist: Ignore; mso-fareast-font-family: Symbol; mso-fareast-language: EN-US; mso-bidi-font-family: Symbol; msofareastlanguage: EN-US;">· <span style="font: 7pt 'Times New Roman'; color: black; msofareastfontfamily: Symbol; msobidifontfamily: Symbol; msolist: Ignore; mso-fareast-font-family: Symbol; mso-fareast-language: EN-US; mso-bidi-font-family: Symbol; msofareastlanguage: EN-US;"> <span style="font-size: 11pt; color: black; font-family: Arial; mso-fareast-font-family: 'Times New Roman'; mso-fareast-language: EN-US;">For OTC products, they aren’t on DailyMed – why do we have to submit SPL electronically only to immediatelyl delist. <span style="font-size: 11pt; color: black; font-family: Symbol; msofareastfontfamily: Symbol; msobidifontfamily: Symbol; msolist: Ignore; mso-fareast-font-family: Symbol; mso-fareast-language: EN-US; mso-bidi-font-family: Symbol; msofareastlanguage: EN-US;">· <span style="font-size: 11pt; color: black; font-family: Arial; mso-fareast-font-family: 'Times New Roman'; mso-fareast-language: EN-US;">If you change the labeler code, you’ll need to submit the Drug Listing under a new setid. **<span style="font-size: 11pt; color: black; font-family: Arial; mso-fareast-font-family: 'Times New Roman'; mso-fareast-language: EN-US;">
 * <span style="font-size: 11pt; color: black; font-family: Arial; mso-fareast-font-family: 'Times New Roman'; mso-fareast-language: EN-US;">Electronically delisting NDCs/products using SPL **

Correcting errors in content of labeling of SPL posted on DailyMed ** <span style="font-size: 11pt; color: black; font-family: Symbol; msofareastfontfamily: Symbol; msobidifontfamily: Symbol; msolist: Ignore; mso-fareast-font-family: Symbol; mso-fareast-language: EN-US; mso-bidi-font-family: Symbol; msofareastlanguage: EN-US;">· <span style="font-size: 11pt; color: black; font-family: Arial; mso-fareast-font-family: 'Times New Roman'; mso-fareast-language: EN-US;">Recently, a few companies accidentally sent unapproved label through the Gateway. If there is an error pointed out, you should __increase the version number and change the docid__ and re-submit. If there is a safety issue with the wrong version, you should contact the SPL@fda.hhs.gov and let them know that it should be pushed through to the DailyMed site as quickly as possible. <span style="font-size: 11pt; color: black; font-family: Symbol; msofareastfontfamily: Symbol; msobidifontfamily: Symbol; msolist: Ignore; mso-fareast-font-family: Symbol; mso-fareast-language: EN-US; mso-bidi-font-family: Symbol; msofareastlanguage: EN-US;">· <span style="font-size: 11pt; color: black; font-family: Arial; mso-fareast-font-family: 'Times New Roman'; mso-fareast-language: EN-US;">FDA is striving to get SPL up to DailyMed within 24 hours.

<span style="font-size: 11pt; color: black; font-family: Symbol; msofareastfontfamily: Symbol; msobidifontfamily: Symbol; msolist: Ignore; mso-fareast-font-family: Symbol; mso-fareast-language: EN-US; mso-bidi-font-family: Symbol; msofareastlanguage: EN-US;">· <span style="font-size: 11pt; color: black; font-family: Arial; mso-fareast-font-family: 'Times New Roman'; mso-fareast-language: EN-US;">There’ve been a lot of issues with submission of R4 SPL that have differences in product information from the R3 version already on DailyMed. <span style="font-size: 11pt; color: black; font-family: Symbol; msofareastfontfamily: Symbol; msobidifontfamily: Symbol; msolist: Ignore; mso-fareast-font-family: Symbol; mso-fareast-language: EN-US; mso-bidi-font-family: Symbol; msofareastlanguage: EN-US;">· <span style="font-size: 11pt; color: black; font-family: Arial; mso-fareast-font-family: 'Times New Roman'; mso-fareast-language: EN-US;">When you get this type of validation failure, send a note to SPL@fda.hhs.gov including the CoreId <span style="font-size: 11pt; color: black; font-family: Symbol; msofareastfontfamily: Symbol; msobidifontfamily: Symbol; msolist: Ignore; mso-fareast-font-family: Symbol; mso-fareast-language: EN-US; mso-bidi-font-family: Symbol; msofareastlanguage: EN-US;">· <span style="font-size: 11pt; color: black; font-family: Arial; mso-fareast-font-family: 'Times New Roman'; mso-fareast-language: EN-US;">Once you move to R4, any changes to packaging or product information will change listing information. It may require changes to the NDC. <span style="font-size: 11pt; color: black; font-family: Arial; mso-fareast-font-family: 'Times New Roman'; mso-fareast-language: EN-US;">
 * <span style="font-size: 11pt; color: black; font-family: Arial; mso-fareast-font-family: 'Times New Roman'; mso-fareast-language: EN-US;">Requesting changes to product data elements in SPL R3 documents via submission of SPL R4 document. **

Question:
<span style="font-size: 11pt; color: black; font-family: Arial; mso-fareast-font-family: 'Times New Roman'; mso-fareast-language: EN-US;">Q:<span style="font-size: 11pt; color: black; font-family: Arial; mso-spacerun: yes; msofareastfontfamily: 'Times New Roman'; msofareastlanguage: EN-US; msospacerun: yes;"> If SPL was submitted for a product that does not currently display on DailyMed, how can I find out if the file was valid and is now in the eList system?

Answer:
<span style="font-size: 11pt; color: black; font-family: Arial; msofareastfontfamily: 'Times New Roman'; mso-fareast-font-family: 'Times New Roman'; mso-fareast-language: EN-US; msofareastlanguage: EN-US;">//If you submit an SPL for a marketing category that is not currently on DailyMed, you can send an e-mail to// //SPL@fda.hhs.gov// //checking on the validity of the file. Include the CoreID (the identifier that is attached to the ESG communications.

Note: If you receive a second acknowledgement in the ESG mailbox, that indicates that the file had one or more validation errors.//

//(per Q&A with FDA on August 29, 2009 at Process / Communication Forum)//
 * Reference(s) :**

<span style="font-size: 11pt; color: black; font-family: Arial; mso-fareast-font-family: 'Times New Roman'; mso-fareast-language: EN-US;">


 * <span style="font-size: 11pt; color: black; font-family: Arial; mso-fareast-font-family: 'Times New Roman'; mso-fareast-language: EN-US;">Requests for SPL for pending applications **

<span style="font-size: 11pt; color: black; font-family: Symbol; msofareastfontfamily: Symbol; msobidifontfamily: Symbol; msolist: Ignore; mso-fareast-font-family: Symbol; mso-fareast-language: EN-US; mso-bidi-font-family: Symbol; msofareastlanguage: EN-US;">· <span style="font-size: 11pt; color: black; font-family: Arial; mso-fareast-font-family: 'Times New Roman'; mso-fareast-language: EN-US;">Recently, some companies may have received a request to update their pending applications. This request was included in some approval letters. We’ve discussed this internally with OND, and are trying to come up with an answer to the question. Historically, companies were not asked to submit their SPL during negotiations. <span style="font-size: 11pt; color: black; font-family: Symbol; msofareastfontfamily: Symbol; msobidifontfamily: Symbol; msolist: Ignore; mso-fareast-font-family: Symbol; mso-fareast-language: EN-US; mso-bidi-font-family: Symbol; msofareastlanguage: EN-US;">· <span style="font-size: 11pt; color: black; font-family: Arial; mso-fareast-font-family: 'Times New Roman'; mso-fareast-language: EN-US;">For a CBE, you should include the most recently approved information in the SPL and should be submitted for Drug Listing. Transmission of SPL error messages - Gateway and E-mail ** <span style="font-size: 11pt; color: black; font-family: Symbol; msofareastfontfamily: Symbol; msobidifontfamily: Symbol; msolist: Ignore; mso-fareast-font-family: Symbol; mso-fareast-language: EN-US; mso-bidi-font-family: Symbol; msofareastlanguage: EN-US;">· <span style="font-size: 11pt; color: black; font-family: Arial; mso-fareast-font-family: 'Times New Roman'; mso-fareast-language: EN-US;">Ideally, we want to receive a receipt and a single acknowledgement <span style="font-size: 11pt; color: black; font-family: Symbol; msofareastfontfamily: Symbol; msobidifontfamily: Symbol; msolist: Ignore; mso-fareast-font-family: Symbol; mso-fareast-language: EN-US; mso-bidi-font-family: Symbol; msofareastlanguage: EN-US;">· <span style="font-size: 11pt; color: black; font-family: Arial; mso-fareast-font-family: 'Times New Roman'; mso-fareast-language: EN-US;">In some cases, where we have your e-mail address, we will try to contact you outside of the gateway. <span style="font-size: 11pt; color: black; font-family: Symbol; msofareastfontfamily: Symbol; msobidifontfamily: Symbol; msolist: Ignore; mso-fareast-font-family: Symbol; mso-fareast-language: EN-US; mso-bidi-font-family: Symbol; msofareastlanguage: EN-US;">· <span style="font-size: 11pt; color: black; font-family: Arial; mso-fareast-font-family: 'Times New Roman'; mso-fareast-language: EN-US;">If you get a third acknowledgement with a Word or PDF attachment, this will contain additional information about validation errors. UNIIs needed for substances in cosmetic and homeopathic drugs ** <span style="font-size: 11pt; color: black; font-family: Arial; mso-fareast-font-family: 'Times New Roman'; mso-fareast-language: EN-US;"> <span style="font-size: 11pt; color: black; font-family: Arial; mso-fareast-font-family: 'Times New Roman'; mso-fareast-language: EN-US;"> Waiver Requests - Complete explanations needed (as stated in final guidance)
 * <span style="font-size: 11pt; color: black; font-family: Arial; mso-fareast-font-family: 'Times New Roman'; mso-fareast-language: EN-US;">
 * <span style="font-size: 11pt; color: black; font-family: Arial; mso-fareast-font-family: 'Times New Roman'; mso-fareast-language: EN-US;">
 * Homeopathic drug substances are not completely indexed in SRS [yet]. FDA is working with authoritative sources from around the world to accurately assign UNIIs as quickly as possible. FDA/USP are striving to have the UNII become an international standard. Sometimes SRS team is asking for draft label or product specification to help with the assignment. Submission of product specification sheets may expedite assignment of UNIIs (not a requirement)
 * <span style="font: 7pt 'Times New Roman'; color: black; msofareastfontfamily: Symbol; msobidifontfamily: Symbol; msolist: Ignore; mso-fareast-font-family: Symbol; mso-fareast-language: EN-US; mso-bidi-font-family: Symbol; msofareastlanguage: EN-US;"> <span style="font-size: 11pt; color: black; font-family: Arial; mso-fareast-font-family: 'Times New Roman'; mso-fareast-language: EN-US;">The situation is similar for inactive ingredients (the delay in UNII assignments).
 * If a product is on hold due to UNII non-assignment, is there any way to get communication from the FDA. If you send an e-mail to the SPL@fda.hhs.gov indicating that a drug is on hold, the FDA will make efforts to expedite the SRS UNII assignment.<span style="font-size: 11pt; color: black; font-family: Arial; mso-fareast-font-family: 'Times New Roman'; mso-fareast-language: EN-US;">

<span style="font: 7pt 'Times New Roman'; color: black; msofareastfontfamily: Symbol; msobidifontfamily: Symbol; msolist: Ignore; mso-fareast-font-family: Symbol; mso-fareast-language: EN-US; mso-bidi-font-family: Symbol; msofareastlanguage: EN-US;">
 * <span style="font-size: 11pt; color: black; font-family: Arial; mso-fareast-font-family: 'Times New Roman'; mso-fareast-language: EN-US;">SPL R4 training sessions (medical gas, cosmetic, OTC, & homeopathic drugs) **<span style="font-size: 11pt; color: black; font-family: Arial; mso-fareast-font-family: 'Times New Roman'; mso-fareast-language: EN-US;">
 * There’s been some concern that companies were not being reached (particularly small companies around the world). An e-mail will be sent to 40,000 companies around the world alerting of upcoming trainings. If there is extremely high response for particular topics, there may be several sessions in a single day. <span style="font-size: 11pt; color: black; font-family: Arial; mso-fareast-font-family: 'Times New Roman'; mso-fareast-language: EN-US;">
 * <span style="font-size: 11pt; color: black; font-family: Arial; mso-fareast-font-family: 'Times New Roman'; mso-fareast-language: EN-US;">Other questions/items **<span style="font-size: 11pt; color: black; font-family: 'Tms Rmn'; mso-fareast-font-family: 'Times New Roman'; mso-fareast-language: EN-US; mso-bidi-font-family: 'Tms Rmn';">
 * <span style="font-size: 11pt; color: black; font-family: Arial; mso-fareast-font-family: 'Times New Roman'; mso-fareast-language: EN-US;">Other questions/items **<span style="font-size: 11pt; color: black; font-family: 'Tms Rmn'; mso-fareast-font-family: 'Times New Roman'; mso-fareast-language: EN-US; mso-bidi-font-family: 'Tms Rmn';">

<span style="font: 7pt 'Times New Roman'; color: black; msofareastfontfamily: Symbol; msobidifontfamily: Symbol; msolist: Ignore; mso-fareast-font-family: Symbol; mso-fareast-language: EN-US; mso-bidi-font-family: Symbol; msofareastlanguage: EN-US;">
 * <span style="font: 7pt 'Times New Roman'; color: black; msofareastfontfamily: Symbol; msobidifontfamily: Symbol; msolist: Ignore; mso-fareast-font-family: Symbol; mso-fareast-language: EN-US; mso-bidi-font-family: Symbol; msofareastlanguage: EN-US;"> <span style="font-size: 11pt; color: black; font-family: Arial; mso-fareast-font-family: 'Times New Roman'; mso-fareast-language: EN-US;">ANDA – we are under the impression that we must submit SPL with the original application. Some review divisions handle SPL differently. According to the electronic labeling rule, you should submit SPL. With the application review, the reviewers are concerned with the __content of labeling.__ Requests after approval for the SPL.
 * <span style="font-size: 11pt; color: black; font-family: Arial; mso-fareast-font-family: 'Times New Roman'; mso-fareast-language: EN-US;">We’ve had a couple instances of submitting SPL to the Review Division and almost simultaneously through the OC. The OC version had validation errors that caused the company to have to resubmit through the Drug Listing process. Does the file need to be resubmitted through the Application Review process?
 * <span style="font-size: 11pt; color: black; font-family: Arial; mso-fareast-font-family: 'Times New Roman'; mso-fareast-language: EN-US;">We were asked to submit SPL, but remove the CBE language before posting. CBE has been filed but not yet approved by the Agency.
 * <span style="font-size: 11pt; color: black; font-family: Arial; mso-fareast-font-family: 'Times New Roman'; mso-fareast-language: EN-US;">Importing a semi-finished product. Manufacturer must do the drug listing to get the product through Customs; however, if a private label distributor __elects__ to list, the manufacturer does not have to list. If there are problems at the border, include the name and number of the Port of Entry in communications to the SPL@fda.hhs.gov
 * <span style="font-size: 11pt; color: black; font-family: Arial; mso-fareast-font-family: 'Times New Roman'; mso-fareast-language: EN-US;">Approved generics: who is responsible for listing these? The manufacturer/registrant is required to list using the generics company PI and NDCs. The authorized generic (private labeler) can ‘elect’ to list.