Chemical Registration and Reporting Requirements
Questions & Answers
Answer: The Control Number assigned is unique for each applicant. An explanation follows:
The chemical registration control number, which is a temporary number issued until final registration is approved, has a total of ten characters.
FOR EXAMPLE: CONTROL NUMBER: W10063838Y
|1:||The first digit is" W" (indicating the applicant applied online) or an "H" (indication the
applicant applied vial mail).
|2-4:||These numbers indicate the Julian date.|
|5-7:||These are random numbers that are computer generated.|
|8-9:||These are random numbers that are computer generated indicating the number of
application in a batch.
|10:||This is a letter which is a code for the activity applied for (i.e., importer, exporter, or
Answer: If an applicant has reason to need information about the status of a chemical application, the applicant should contact their local DEA office and ask to speak with a Diversion Investigator who will assist them.
Question: Do firms that are reporting mail order transactions have to report sales that are below the threshold for the product?
Answer: Yes, the Comprehensive Methamphetamine Control Act of 1996 (MCA), Section 402, states the following:
"(3) Mail order reporting... Each regulated person who engages in a transaction with a nonregulated person which
(i) involves ephedrine, pseudoephedrine, or phenylpropanolamine (including drug products containing these chemicals); and
(ii) Uses or attempts to use the Postal Service or any private or commercial carrier shall, on a monthly basis, submit a report of each such transaction conducted during the previous month to the Attorney General in such form, containing such data."
(B) The data required for such report shall include:
"(I) The name of the purchaser,
(II) The quantity and form of the chemical [ephedrine, pseudoephedrine, or
phenylpropanolamine] purchased, and
(III) The address to which the chemical [ephedrine, pseudoephedrine, or phenylpropanolamine] was sent."
While not required at this time, the date of each transaction, the trade name, and the lot number of the product distributed (where applicable) are requested.
Reports should be mailed to:
Drug Enforcement Administration
Office of Diversion Control
Chemical Control Section (ODIA)
Washington, D.C. 20537
Mail order reporting guidelines were published in the Federal Register, February 7, 1997, No 26 (62 FR 5851).
Question: On the Application for Chemical Registration, DEA Form 510, which Business Activity category should be checked in question number one if the business is classified as a "Wholesaler?"
Answer: Distributor, because, according to 21 CFR 1300.02 (b)(29), "The term retail distributor means a grocery store, general merchandise store, drug store, or other entity or person whose activities as a distributor relating to drug products containing pseudoephedrine, phenylpropanolamine, or ephedrine are limited almost exclusively to sales for personal use, both in number of sales and volume of sales, either directly to walk-in customers or in face-to-face transactions by direct sales. For the purposes of this paragraph, sale for personal use means the distribution of below-threshold quantities in a single transaction to an individual for legitimate medical use." If a firm's activities do not meet this definition, then they are a "Distributor."
Answer: No. 21 USC 822 (2)(e) states the following, "A separate registration shall be required at each principal place of business or professional practice where the applicant manufactures, distributes, or dispenses controlled substances or List I Chemicals."
A registrant may include a Post Office Box in addition to the physical location where the activities are carried out. Therefore, the registration must reflect the location from which the chemicals are distributed, imported, or exported.