| (a) License fee. Except as provided by §229.423
of this subchapter (relating to Exemptions), no person may operate
or conduct business as a wholesale distributor of prescription drugs
without first obtaining a license from the department. All applicants
for an initial wholesale distributor of prescription drugs license
or a renewal license must pay a licensing fee unless otherwise exempt
as provided by subsection (c) of this section. All fees are nonrefundable.
Licenses are issued for two-year terms. A license shall only be issued
when all past due license fees and delinquency fees are paid.
(1) In-state and out-of-state wholesale distributors
of prescription drugs who are not manufacturers must pay a two-year
license fee based on the gross annual sales of all drugs.
(A) For a wholesale distributor of only medical gases,
the fees are:
(i) $675 for a two-year license;
(ii) $675 for a two-year license issued to a change
of ownership; and
(iii) $337 for a license amended during the current
licensure period due to minor changes.
(B) For a wholesale distributor with gross annual drug
sales of $0 - $199,999.99, the fees are:
(i) $1,080 for a two-year license;
(ii) $1,080 for a two-year license issued due to a
change of ownership; and
(iii) $540 for a license amended during the current
licensure period due to minor changes.
(C) For a wholesale distributor with gross annual drug
sales of $200,000 - $19,999,999.99, the fees are:
(i) $1,755 for a two-year license;
(ii) $1,755 for a two-year license issued due to a
change of ownership; and
(iii) $877 for a license amended during the current
licensure period due to minor changes.
(D) For a wholesale distributor with gross annual drug
sales greater than or equal to $20 million, the fees are:
(i) $2,295 for a two-year license;
(ii) $2,295 for a two-year license issued due to a
change of ownership; and
(iii) $1,147 for a license amended during the current
licensure period due to minor changes.
(2) In-state and out-of-state wholesale distributors
of medical gases who are not manufacturers and who also are required
to be licensed as a device distributor under §229.439(a) of this
chapter (relating to Licensure Fees) or as a wholesale food distributor
under §229.182(a)(3) of this chapter (relating to Licensing/Registration
Fee and Procedures) must pay a combined two-year license fee for each
place of business. License fees are based on the combined gross annual
sales of these regulated products (medical gases, foods, drugs, and
devices) as follows:
(A) For combined gross annual sales of $0 - $199,999.99,
the fees are:
(i) $540 for a two-year license;
(ii) $540 for a two-year license issued due to a change
of ownership; and
(iii) $270 for a license amended during the current
licensure period due to minor changes.
(B) For combined gross annual sales of $200,000 - $499,999.99,
the fees are:
(i) $810 for a two-year license;
(ii) $810 for a two-year license issued due to a change
of ownership; and
(iii) $405 for a license amended during the current
licensure period due to minor changes.
(C) For combined gross annual sales of $500,000 - $999,999.99,
the fees are:
(i) $1,080 for a two-year license;
(ii) $1,080 for a two-year license issued due to a
change of ownership; and
(iii) $540 for a license amended during the current
licensure period due to minor changes.
(D) For combined gross annual sales of $1 million -
$9,999,999.99, the fees are:
(i) $1,350 for a two-year license;
(ii) $1,350 for a two-year license issued due to a
change of ownership; and
(iii) $675 for a license issued during the current
licensure period due to minor changes.
(E) For combined gross annual sales greater than or
equal to $10 million, the fees are:
(i) $2,025 for a two-year license;
(ii) $2,025 for a two-year license issued due to a
change of ownership; and
(iii) $1,012 for a license amended during the current
licensure period due to minor changes.
(3) In-state and out-of-state manufacturers of only
medical gases must pay a two-year license fee based on the gross annual
sales of all prescription drugs as follows.
(A) For gross annual drug sales of $0 - $199,999.99,
the fees are:
(i) $1,080 for a two-year license;
(ii) $1,080 for a two-year license issued due to a
change of ownership; and
(iii) $540 for a license amended during the current
licensure period due to minor changes.
(B) For gross annual drug sales of $200,000 - $19,999,999.99,
the fees are:
(i) $1,755 for a two-year license;
(ii) $1,755 for a two-year license issued due to a
change of ownership; and
(iii) $877 for a license amended during the current
licensure period due to minor changes.
(C) For gross annual drug sales greater than or equal
to $20 million, the fees are:
(i) $2,295 for a two-year license;
(ii) $2,295 for a two-year license issued due to a
change of ownership; and
(iii) $1,147 for a license amended during the current
licensure period due to minor changes.
(4) In-state and out-of-state manufacturers of prescription
drugs must pay a two-year license fee based on the gross annual sales
of all drugs as follows.
(A) For gross annual drug sales of $0 - $199,999.99,
the fees are:
(i) $1,080 for a two-year license;
(ii) $1,080 for a two-year license issued due to a
change of ownership; and
(iii) $540 for a license amended during the current
licensure period due to minor changes.
(B) For gross annual drug sales of $200,000 - $1,999,999.99,
the fees are:
(i) $1,350 for a two-year license;
(ii) $1,350 for a two-year license issued due to a
change of ownership; and
(iii) $697 for a license amended during the current
licensure period due to minor changes.
(C) For gross annual drug sales of $2 million - $9,999,999.99,
the fees are:
(i) $1,620 for a two-year license;
(ii) $1,620 for a two-year license issued due to a
change of ownership; and
(iii) $847 for a license amended during the current
licensure period due to minor changes.
(D) For gross annual drug sales of $10 million to $19,999,999.99,
the fees are:
(i) $1,890 for a two-year license;
(ii) $1,890 for a two-year license issued due to a
change of ownership; and
(iii) $997 for a license amended during the current
licensure period due to minor changes.
(E) For gross annual drug sales greater than or equal
to $20 million, the fees are:
(i) $2,295 for a two-year license;
(ii) $2,295 for a two-year license issued due to a
change of ownership; and
(iii) $1,147 for a license amended during the current
licensure period due to minor changes.
(b) Replacement license fee. The replacement license
fee is $100.
(c) Proration of license fees. A person having more
than one place of business may request a one-time proration of the
license fees when applying for a license for each new place of business.
Upon approval by the department, the license for the new place of
business will have a renewal date the same as the firm's other licensed
places of business.
(d) Exemption from license fees. A person is exempt
from the license fees required by this section if the person is a
charitable organization, as described in the Internal Revenue Code
of 1986, 26 USC §501(c)(3), or a nonprofit affiliate of the organization,
to the extent otherwise permitted by law.
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