Texas Administrative Code
Title 25 - HEALTH SERVICES
Part 1 - DEPARTMENT OF STATE HEALTH SERVICES
Chapter 229 - FOOD AND DRUG
Subchapter O - LICENSING OF WHOLESALE DISTRIBUTORS OF NONPRESCRIPTION DRUGS-INCLUDING GOOD MANUFACTURING PRACTICES
Section 229.249 - Licensure Fees

Universal Citation: 25 TX Admin Code ยง 229.249

Current through Reg. 49, No. 38; September 20, 2024

(a) License fee. Except as provided by § 229.245 of this subchapter (relating to Exemption), no person may operate or conduct business as a wholesale distributor of nonprescription drugs without first obtaining a license from the department. All applicants for an initial wholesale distributor of nonprescription 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 administrative penalties, license fees, and delinquency fees are paid.

(1) In-state wholesale distributors of nonprescription drugs who are not manufacturers must pay a two-year license fee based on the gross annual sales of all nonprescription drugs.
(A) For a wholesale distributor with gross annual nonprescription drug sales of $0 - $199,999.99, the fees are:
(i) $1,040 for a two-year license;

(ii) $1,040 for a two-year license issued due to a change of ownership; and

(iii) $520 for a license issued during the current licensure period due to minor changes.

(B) For a wholesale distributor with gross annual nonprescription drug sales of $200,000 - $19,999,999.99, the fees are:
(i) $1,690 for a two-year license;

(ii) $1,690 for a two-year license issued due to a change of ownership; and

(iii) $845 for a license issued during the current licensure period due to minor changes.

(C) For a wholesale distributor with gross annual nonprescription drug sales greater than or equal to $20 million, the fees are:
(i) $2,210 for a two-year license;

(ii) $2,210 for a two-year license issued due to a change of ownership; and

(iii) $1,105 for a license issued during the current licensure period due to minor changes.

(2) In-state wholesale distributors of nonprescription drugs 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 (foods, drugs, and devices).
(A) For each place of business having combined gross annual sales of $0 - $199,999.99, the fees are:
(i) $520 for a two-year license;

(ii) $520 for a two-year license issued due to a change of ownership; and

(iii) $260 for a license amended during the current licensure period due to minor changes.

(B) For each place of business having combined gross annual sales of $200,000 - $499,999.99, the fees are:
(i) $780 for a two-year license;

(ii) $780 for a two-year license issued due to a change of ownership; and

(iii) $390 for a license amended during the current licensure period due to minor changes.

(C) For each place of business having combined gross annual sales of $500,000 - $999,999.99, the fees are:
(i) $1,040 for a two-year license;

(ii) $1,040 for a two-year license issued due to a change of ownership; and

(iii) $520 for a license amended during the current licensure period due to minor changes.

(D) For each place of business having combined gross annual sales of $1 million - $9,999,999.99, the fees are:
(i) $1,300 for a two-year license;

(ii) $1,300 for a two-year license issued due to a change of ownership; and

(iii) $650 for a license amended during the current licensure period due to minor changes.

(E) For each place of business having combined gross annual sales greater than or equal to $10 million, the fees are:
(i) $1,950 for a two-year license;

(ii) $1,950 for a two-year license issued due to a change of ownership; and

(iii) $975 for a license amended during the current licensure period due to minor changes.

(3) In-state wholesale distributors of nonprescription drugs who are manufacturers must pay a two-year license fee based on the gross annual sales of all nonprescription drugs.
(A) For a wholesale distributor with gross annual nonprescription drug sales of $0 - $199,999.99, the fees are:
(i) $1,040 for a two-year license;

(ii) $1,040 for a two-year license issued due to a change of ownership; and

(iii) $520 for a license amended during the current licensure period due to minor changes.

(B) For a wholesale distributor with gross annual nonprescription drug sales of $200,000 - $1,999,999.99, the fees are:
(i) $1,235 for a two-year license;

(ii) $1,235 for a two-year license issued due to a change of ownership; and

(iii) $620 for a license amended during the current licensure period due to minor changes.

(C) For a wholesale distributor with gross annual nonprescription drug sales of $2 million to $9,999,999.99, the fees are:
(i) $1,560 for a two-year license;

(ii) $1,560 for a two-year license issued due to a change of ownership; and

(iii) $780 for a license amended during the current licensure period due to minor changes.

(D) For a wholesale distributor with gross annual nonprescription drug sales of $10 million to $19,999,999.99, the fees are:
(i) $1,885 for a two-year license;

(ii) $1,885 for a two-year license issued due to a change of ownership; and

(iii) $940 for a license amended during the current licensure period due to minor changes.

(E) For a wholesale distributor with gross annual nonprescription drug sales greater than or equal to $20 million, the fees are:
(i) $2,210 for a two-year license;

(ii) $2,210 for a two-year license issued due to a change of ownership; and

(iii) $1,105 for a license amended during the current licensure period due to minor changes.

(4) Out-of-state wholesale distributors of nonprescription drugs must pay a two-year license fee based on all gross annual sales of nonprescription drugs delivered into Texas.
(A) For each wholesale distributor with gross annual nonprescription drug sales of $0 - $19,999,999.99, the fees are:
(i) $1,300 for a two-year license;

(ii) $1,300 for a two-year license issued due to a change of ownership; and

(iii) $650 for a license amended during the current licensure period due to minor changes.

(B) For each wholesale distributor with gross annual nonprescription drug sales of greater than or equal to $20 million, the fees are:
(i) $1,950 for a two-year license;

(ii) $1,950 for a two-year license issued due to a change of ownership; and

(iii) $975 for a license amended during the current licensure period due to minor changes.

(b) 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.

(c) 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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