Texas Administrative Code
Title 25 - HEALTH SERVICES
Part 1 - DEPARTMENT OF STATE HEALTH SERVICES
Chapter 229 - FOOD AND DRUG
Subchapter W - LICENSING OF WHOLESALE DISTRIBUTORS OF PRESCRIPTION DRUGS-INCLUDING GOOD MANUFACTURING PRACTICES
Section 229.427 - Licensure Fees
Universal Citation: 25 TX Admin Code ยง 229.427
Current through Reg. 49, No. 38; September 20, 2024
(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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