<<Prev Rule

Texas Administrative Code

Next Rule>>
TITLE 25HEALTH SERVICES
PART 1DEPARTMENT OF STATE HEALTH SERVICES
CHAPTER 229FOOD AND DRUG
SUBCHAPTER WLICENSING OF WHOLESALE DISTRIBUTORS OF PRESCRIPTION DRUGS--INCLUDING GOOD MANUFACTURING PRACTICES
RULE §229.427Licensure Fees

(a) License fee. Except as provided by §229.423 of this title (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 shall 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 shall 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 that is due to a change of ownership; and

      (iii) $337 for a license that is 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) $1080 for a two-year license;

      (ii) $1080 for a two-year license that is due to a change of ownership; and

      (iii) $540 for a license that is 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) $1755 for a two-year license;

      (ii) $1755 for a two-year license that is due to a change of ownership; and

      (iii) $877 for a license that is 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) $2295 for a two-year license;

      (ii) $2295 for a two-year license that is due to a change of ownership; and

      (iii) $1147 for a license that is 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 title (relating to Licensure Fees) or as a wholesale food distributor under §229.182(a)(3) of this title (relating to Licensing/Registration Fee and Procedures) shall 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/or 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 that is due to a change of ownership; and

      (iii) $270 for a license that is 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 that is due to a change of ownership; and

      (iii) $405 for a license that is 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) $1080 for a two-year license;

      (ii) $1080 for a two-year license that is due to a change of ownership; and

      (iii) $540 for a license that is 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) $1350 for a two-year license;

      (ii) $1350 for a two-year license that is due to a change of ownership; and

      (iii) $675 for a license that is amended 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) $2025 for a two-year license;

      (ii) $2025 for a two-year license that is due to a change of ownership; and

      (iii) $1012 for a license that is amended during the current licensure period due to minor changes.

  (3) In-state and out-of-state manufacturers of only medical gases shall 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) $1080 for a two-year license;

      (ii) $1080 for a two-year license that is due to a change of ownership; and

      (iii) $540 for a license that is 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) $1755 for a two-year license;

      (ii) $1755 for a two-year license that is due to a change of ownership; and

      (iii) $877 for a license that is 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) $2295 for a two-year license;

      (ii) $2295 for a two-year license that is due to a change of ownership; and

      (iii) $1147 for a license that is amended during the current licensure period due to minor changes.

  (4) In-state and out-of-state manufacturers of prescription drugs shall 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) $1080 for a two-year license;

      (ii) $1080 for a two-year license that is due to a change of ownership; and

      (iii) $540 for a license that is 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) $1755 for a two-year license;

      (ii) $1755 for a two-year license that is due to a change of ownership; and

      (iii) $877 for a license that is 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) $2295 for a two-year license;

      (ii) $2295 for a two-year license that is due to a change of ownership; and

      (iii) $1147 for a license that is 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 that has 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 that is 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, §501(c)(3), or a nonprofit affiliate of the organization, to the extent otherwise permitted by law.


Source Note: The provisions of this §229.427 adopted to be effective February 1, 2007, 32 TexReg 315; amended to be effective December 9, 2010, 35 TexReg 10755

Next Page Previous Page



Home TxReg TAC OM NewTac Public Footer Bar