21 Cfr 1301.11

21 CFR 1301.1.mht

Application for Registration (DEA Form 363) and Application for Registration Renewal (DEA Form 363a)

21 CFR 1301.11

OMB: 1117-0015

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class=3Dmainheader>Title 21:=20
      Food and Drugs</SPAN></STRONG><BR><SPAN class=3Ddiv5head><A=20
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href=3D"http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=3Decfr;sid=3D7ee9=
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;idno=3D21;cc=3Decfr"=20
      name=3D21:9.0.1.1.2>PART 1301=97REGISTRATION OF MANUFACTURERS, =
DISTRIBUTORS,=20
      AND DISPENSERS OF CONTROLLED SUBSTANCES</A></SPAN> <BR><SPAN=20
      class=3Ddiv7head><A=20
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      Next</A></SPAN><BR>
      <H5>=A7&nbsp;1301.11&nbsp;&nbsp;&nbsp;Persons required to =
register;=20
      requirement of modification of registration authorizing activity =
as an=20
      online pharmacy.</H5>
      <P>(a) Every person who manufactures, distributes, dispenses, =
imports, or=20
      exports any controlled substance or who proposes to engage in the=20
      manufacture, distribution, dispensing, importation or exportation =
of any=20
      controlled substance shall obtain a registration unless exempted =
by law or=20
      pursuant to =A7=A71301.22 through 1301.26. Except as provided in =
paragraph (b)=20
      of this section, only persons actually engaged in such activities =
are=20
      required to obtain a registration; related or affiliated persons =
who are=20
      not engaged in such activities are not required to be registered. =
(For=20
      example, a stockholder or parent corporation of a corporation=20
      manufacturing controlled substances is not required to obtain a=20
      registration.)</P>
      <P>(b) As provided in sections 303(f) and 401(h) of the Act (21 =
U.S.C.=20
      823(f) and 841(h)), it is unlawful for any person who falls within =
the=20
      definition of =93online pharmacy=94 (as set forth in section =
102(52) of the=20
      Act (21 U.S.C. 802(52)) and =A71300.04(h) of this chapter) to =
deliver,=20
      distribute, or dispense a controlled substance by means of the =
Internet if=20
      such person is not validly registered with a modification of such=20
      registration authorizing such activity (unless such person is =
exempt from=20
      such modified registration requirement under the Act or this =
chapter). The=20
      Act further provides that the Administrator may only issue such=20
      modification of registration to a person who is registered as a =
pharmacy=20
      under section 303(f) of the Act (21 U.S.C. 823(f)). Accordingly, =
any=20
      pharmacy registered pursuant to =A71301.13 of this part that falls =
within=20
      the definition of an online pharmacy and proposes to dispense =
controlled=20
      substances by means of the Internet must obtain a modification of =
its=20
      registration authorizing such activity following the submission of =
an=20
      application in accordance with =A71301.19 of this part. This =
requirement=20
      does not apply to a registered pharmacy that does not fall within =
the=20
      definition of an online pharmacy set forth in =A71300.04(h). Under =
the Act,=20
      persons other than registered pharmacies are not eligible to =
obtain such a=20
      modification of registration but remain liable under section =
401(h) of the=20
      Act (21 U.S.C. 841(h)) if they deliver, distribute, or dispense a=20
      controlled substance while acting as an online pharmacy without =
being=20
      validly registered with a modification authorizing such =
activity.</P>
      <P>[74 FR 15621, Apr. 6, 2009]</P>
      <P></P><SPAN><A=20
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href=3D"http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=3Decfr;sid=3D7ee9=
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      508 / Accessibility</A></P><!--<P ALIGN=3D"center" =
CLASS=3D"footer">Last updated: < !-- #BeginDate format:Am1 -- >August 1, =
2007<!-- #EndDate -- ></P>
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