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e-CFR
Data is current as of May 13, 2011

Title 21:
Food and Drugs
PART 1301—REGISTRATION OF MANUFACTURERS, DISTRIBUTORS,
AND DISPENSERS OF CONTROLLED SUBSTANCES
Registration

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§ 1301.11   Persons required to register;
requirement of modification of registration authorizing activity as an
online pharmacy.

(a) Every person who manufactures, distributes, dispenses, imports, or
exports any controlled substance or who proposes to engage in the
manufacture, distribution, dispensing, importation or exportation of any
controlled substance shall obtain a registration unless exempted by law or
pursuant to §§1301.22 through 1301.26. Except as provided in paragraph (b)
of this section, only persons actually engaged in such activities are
required to obtain a registration; related or affiliated persons who are
not engaged in such activities are not required to be registered. (For
example, a stockholder or parent corporation of a corporation
manufacturing controlled substances is not required to obtain a
registration.)

(b) As provided in sections 303(f) and 401(h) of the Act (21 U.S.C.
823(f) and 841(h)), it is unlawful for any person who falls within the
definition of “online pharmacy” (as set forth in section 102(52) of the
Act (21 U.S.C. 802(52)) and §1300.04(h) of this chapter) to deliver,
distribute, or dispense a controlled substance by means of the Internet if
such person is not validly registered with a modification of such
registration authorizing such activity (unless such person is exempt from
such modified registration requirement under the Act or this chapter). The
Act further provides that the Administrator may only issue such
modification of registration to a person who is registered as a pharmacy
under section 303(f) of the Act (21 U.S.C. 823(f)). Accordingly, any
pharmacy registered pursuant to §1301.13 of this part that falls within
the definition of an online pharmacy and proposes to dispense controlled
substances by means of the Internet must obtain a modification of its
registration authorizing such activity following the submission of an
application in accordance with §1301.19 of this part. This requirement
does not apply to a registered pharmacy that does not fall within the
definition of an online pharmacy set forth in §1300.04(h). Under the Act,
persons other than registered pharmacies are not eligible to obtain such a
modification of registration but remain liable under section 401(h) of the
Act (21 U.S.C. 841(h)) if they deliver, distribute, or dispense a
controlled substance while acting as an online pharmacy without being
validly registered with a modification authorizing such activity.

[74 FR 15621, Apr. 6, 2009]

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