[Title 21 CFR 1301.17]
[Code of Federal Regulations (annual edition) - April 1, 2002 Edition]
[Title 21 - FOOD AND DRUGS]
[Chapter II - DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE]
[Part 1301 - REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS OF CONTROLLED SUBSTANCES]
[Sec. 1301.17 - Special procedures for certain applications.]
[From the U.S. Government Printing Office]
21FOOD AND DRUGS92002-04-012002-04-01falseSpecial procedures for certain applications.1301.17Sec. 1301.17FOOD AND DRUGSDRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICEREGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS OF CONTROLLED SUBSTANCES
Sec. 1301.17 Special procedures for certain applications.
(a) If, at the time of application for registration of a new
pharmacy, the pharmacy has been issued a license from the appropriate
State licensing agency, the applicant may include with his/her
application an affidavit as to the existence of the State license in the
following form:
Affidavit for New Pharmacy
I, --------------------, the -------------------- (Title of officer,
official, partner, or other position) of --------------------
(Corporation, partnership, or sole proprietor), doing business as ------
-------------- (Store name) at -------------------- (Number and Street),
-------------------- (City) ------------ (State) ------------ (Zip
code), hereby certify that said store was issued a pharmacy permit No.
-------- by the ---------------- (Board of Pharmacy or Licensing Agency)
of the State of ------------ on ------------ (Date).
This statement is submitted in order to obtain a Drug Enforcement
Administration registration number. I understand that if any information
is false, the Administration may immediately suspend the registration
for this store and commence proceedings to revoke under 21 U.S.C. 824(a)
because of the danger to public health and safety. I further understand
that any false information contained in this affidavit may subject me
personally and the above-named corporation/partnership/business to
prosecution under 21 U.S.C. 843, the penalties for conviction of which
include imprisonment for up to 4 years, a fine of not more than $30,000
or both.
________________________________________________________________________
Signature (Person who signs Application for Registration)
State of________________________________________________________________
County of_______________________________________________________________
Subscribed to and sworn before me this -------- day of --------,
19------.
________________________________________________________________________
Notary Public
(b) Whenever the ownership of a pharmacy is being transferred from
one person to another, if the transferee owns at least one other
pharmacy licensed in the same State as the one the ownership of which is
being transferred, the transferee may apply for registration prior to
the date of transfer. The Administrator may register the applicant and
authorize him to obtain controlled substances at the time of transfer.
Such registration shall not authorize the transferee to dispense
controlled substances until the pharmacy has been issued a valid State
license. The transferee shall include with his/her application the
following affidavit:
Affidavit for Transfer of Pharmacy
I, --------------------, the -------------------- (Title of officer,
official, partner or other position) of --------------------
(Corporation, partnership, or sole proprietor), doing business as ------
-------------- (Store name) hereby certify:
(1) That said company was issued a pharmacy permit No.------------by
the -------------------- (Board of Pharmacy of Licensing Agency) of the
State of ------------ and a DEA Registration Number --------------------
for a pharmacy located at -------------------- (Number and Street) ----
-------- (City) ------------ (State) ------------ (Zip Code); and
(2) That said company is acquiring the pharmacy business of --------
------------ (Name of Seller) doing business
[[Page 20]]
as--------------------with DEA Registration Number ------------ on or
about ------------ (Date of Transfer) and that said company has applied
(or will apply on ------------ (Date) for a pharmacy permit from the
board of pharmacy (or licensing agency) of the State of ------------ to
do business as -------------------- (Store name) at --------------------
(Number and Street) -------------------- (City) ------------ (State) --
---------- (Zip Code).
This statement is submitted in order to obtain a Drug Enforcement
Administration registration number.
I understand that if a DEA registration number is issued, the
pharmacy may acquire controlled substances but may not dispense them
until a pharmacy permit or license is issued by the State board of
pharmacy or licensing agency.
I understand that if any information is false, the Administration
may immediately suspend the registration for this store and commence
proceedings to revoke under 21 U.S.C. 824(a) because of the danger to
public health and safety. I further understand that any false
information contained in this affidavit may subject me personally to
prosecution under 21 U.S.C. 843, the penalties for conviction of which
include imprisonment for up to 4 years, a fine of not more than $30,000
or both.
________________________________________________________________________
Signature (Person who signs Application for Registration)
State of________________________________________________________________
County of_______________________________________________________________
Subscribed to and sworn before me this----day of------------, 19--
--.
________________________________________________________________________
Notary Public
(c) The Administrator shall follow the normal procedures for
approving an application to verify the statements in the affidavit. If
the statements prove to be false, the Administrator may revoke the
registration on the basis of section 304(a)(1) of the Act (21 U.S.C.
824(a)(1)) and suspend the registration immediately by pending
revocation on the basis of section 304(d) of the Act (21 U.S.C. 824(d)).
At the same time, the Administrator may seize and place under seal all
controlled substances possessed by the applicant under section 304(f) of
the Act (21 U.S.C. 824(f)). Intentional misuse of the affidavit
procedure may subject the applicant to prosecution for fraud under
section 403(a)(4) of the Act (21 U.S.C. 843(a)(4)), and obtaining
controlled substances through registration by fraudulent means may
subject the applicant to prosecution under section 403(a)(3) of the Act
(21 U.S.C. 843(a)(3)). The penalties for conviction of either offense
include imprisonment for up to 4 years, a fine not exceeding $30,000 or
both.
[62 FR 13949, Mar. 24, 1997]