Frequently Asked Questions:

Below are some things to keep in mind when completing the 2004 year-end reports (i.e. calendar year 2003 data).

Certain opiates are utilized in the United States by DEA registered manufacturers for one of two purposes: 1) for the manufacture of other opiates / basic classes and 2) for the manufacture of dosage forms containing that opiate. The DEA discriminates between these two activities by administering quotas for that basic class as either "for conversion" or "for sale". The applicable opiates include: codeine, hydrocodone, methadone, morphine, noroxymorphone and oxycodone.

Example of a firm obtaining a "morphine (for conversion)" quota.

Company A produces bulk morphine. Company B procures bulk morphine from Company A and utilizes the morphine to make codeine, a new basic class which the firm subsequently sells in bulk form to a DEA registered dosage form manufacturers. Company A receives a bulk manufacturing quota from the DEA for "morphine (for conversion)" and Company B receives a procurement quota from the DEA for "morphine (for conversion)".

Example of a firm obtaining a morphine (for sale)" quota.

In the above mentioned example, lets say that Company C is the dosage form manufacturer and they make various codeine preparations, one of which is in Schedule III and the other is in Schedule V. Since Company C is not intending on procuring codeine to make a different basic class of controlled substance (hydrocodone for instance), they merely intend on procuring codeine to make codeine preparations. Company C receives a procurement quota for "codeine (for sale)". Some registrants have thought that because they are making a codeine preparation that is in a schedule other than Schedule II, they should request and receive a quota for "codeine (for conversion)". Please be aware this is not the case.

The confusion on the issue of "for sale" vs. "for conversion" was apparent with receipt of the Year-End Reports in the 2003 reporting year. The DEA received an approximate 50/50 mix of "for sale" vs. "for conversion" reports for any of the aforementioned opiates, however, the vast majority (if not all) of the reports it should receive for any opiate should be "for sale" as there are very few manufacturers in the United States that utilize one basic class for the manufacture of a completely different drug molecule. If you are having difficulty deciding which report to select when creating your report package, choose that report for which you have received a quota for.

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The first step in utilizing the Year-End Report Generator is to create a Report Package. During this step, the computer asks questions about what you’ve 1) received quotas for and 2) what you maintain inventory of. Therefore, you should complete a report for each basic class in Schedule I or II for which your firm either had inventory of in the reporting year or a report for which your firm received a quota for (bulk manufacturing or procurement) during the reporting year. With this information at hand before you create your report package, you should be able to pick the controlled substance(s) you will need to report on.

No, you are not required to utilize the software to complete the Year-End Reports. If you chose not to use the software to assist in completing your firm’s reports, then you can obtain a blank form from the software by creating a report package and then printing the blank report, or by calling the Office of Diversion Control and having an electronic or hard copy sent to you.

DEA registered manufacturers are encouraged to utilize the software however, because it significantly cuts down on erroneous report submissions that subsequently require DEA to request a re-submission.

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Ensure that there was not an error in you calculation. If there was no error, contact the Office of Diversion Control at 202-307-7183.

The following are some error messages that were encountered by last year’s new users of the Year-End Report Generator.

This was an unanticipated error message noted by the first of many companies whose computers were using inkjet-style printers. Thus, this year we have suggested that companies have access to a laser jet printer for printing reports.

This appears to be an error with some companies that attempted to complete a custom installation on their companies’ network computer system. This can be alleviated by trying the installation on a non-networked computer.