(a) All charitable drug donors in Texas shall obtain a wholesale drug distributor license annually with the department.
(b) Charitable drug donors are exempt from the license fee, but otherwise are subject to and must comply with the requirements of this chapter.
(c) If the United States Food and Drug Administration (FDA) determines, with respect to a product that is a combination of a drug and a device that the primary mode of action of the product is as a drug, a person who engages in donation of the product is subject to licensing as described in this section.
(d) License forms. License application forms may be obtained from the department at 1100 West 49th Street, Austin, Texas 78756 or online at http://www.dshs.state.tx.us/license.shtm.
(e) License statement. The charitable drug donors' licensing statement shall be signed and verified by the owner, partner, president, or corporate designee (authorized person), shall be made on the department furnished license form, and shall contain the following information:
  (1) the legal name under which the business is conducted;
  (2) the address of each place of business that is licensed;
  (3) if a proprietorship, the name and residence address of the proprietor; if a partnership, the names and residence addresses of all partners; if a corporation, the date and place of incorporation and name and address of its registered agent in the state; or if any other type of association, then the names of the principals of such association;
  (4) the names, residence addresses, and valid driver's license of those individuals in an actual administrative capacity which, in the case of proprietorship, shall be the managing proprietor, partnership, the managing partner, corporation, the officers and directors, or those in a managerial capacity in any other type of association; and
  (5) for each place of business, the residence addresses of the individuals in charge thereof.
(f) Two or more places of business. If the charitable drug donor operates more than one place of business, the charitable drug donor shall license each place of business separately.
(g) Pre-licensing inspection. The applicant shall cooperate with any pre-licensing inspection by the department of the charitable drug donor's facilities. The department may accept reports from authorities in other jurisdictions to determine the extent of compliance with the minimum standards in this chapter for applicants located out-of-state.
(h) Issuance of license. The department may license a charitable drug donor who meets the requirements of this section, and §229.251 of this title (relating to Minimum Standards for Licensure) for "Licensing of Wholesale Distributors of Nonprescription Drugs--Including Good Manufacturing Practices," and §229.429 of this title (relating to Minimum Standards for Licensure) for "Licensing of Wholesale Distributors of Prescription Drugs--Including Good Manufacturing Practices."
(i) The initial license shall be valid for two years from the date of issuance which becomes the anniversary date.
(j) The renewal license shall be valid for two years from the anniversary date.
(k) Renewal of license.
  (1) Each year, the charitable drug donor shall renew its license following the requirements of this section, and §229.253 of this title.
  (2) A person who holds a license issued by the department under the Health and Safety Code, Chapter 431 shall renew the license by submitting an application for renewal on a form prescribed by the department. A licensee must submit for renewal before the expiration date of the current license. A person who submits a renewal application after the expiration date must pay an additional $100 as a delinquency fee.
  (3) A licensee who fails to submit a renewal application prior to the current licensure expiration date and continues operations may be subject to the enforcement and penalty provisions in §229.252 and §229.430 of this title (relating to Enforcement and Penalties), and/or the refusal, cancellation, suspension and revocation provisions in §229.250 and §229.428 of this title (relating to Refusal, Cancellation, Suspension or Revocation of License).
(l) Amendment of license. A license that is amended, including a change of name, ownership, or a notification of a change in the location of a licensed place of business required under the Health and Safety Code, §431.206 will require submission of a new application as required by this section.
(m) Notification of change of location of place of business. Not fewer than 30 days in advance of the change, the licensee shall notify the department in writing of the licensee's intent to change the location of a licensed place of business. The notice shall include the address of the new location, and the name and residence address of the individual in charge of the business at the new location. Not more than ten days after the completion of the change of location, the licensee shall notify the department in writing to verify the change of location, the address of the new location, and the name and residence address of the individual in charge of the business at the new address. Notice will be deemed adequate if the licensee provides the intent and verification notices to the department by certified mail, return receipt requested, mailed to the department.
(n) Exemption from licensing. Persons who engage in the following charitable donations of prescription drugs for use in humans are exempt from the licensing requirements of this subchapter, to the extent that the donation does not violate the Health and Safety Code, Chapter 481, the Texas Controlled Substances Act, or Chapter 483, the Texas Dangerous Drug Act:
  (1) intracompany donation;
  (2) the donation of a drug by a charitable medical clinic to a nonprofit affiliate of the organization to the extent otherwise permitted by law;
  (3) the donation of a drug or an offer to donate a drug among hospitals or other health care entities that is under common control. For the purpose of this subsection, "common control" means the power to direct or cause the direction of the management and policies of a person or an organization, whether by ownership of stock, voting rights, contract, or otherwise; and
  (4) the donation of drug samples by manufacturers' representatives.
(o) Donation of drugs. The provisions of this section regarding the donation of drugs shall be considered to include the manufacture, production, processing, packaging, exposure, offer, possession, and holding of any such article for donation; and the donation, dispensing, and giving of any such article, and the supplying or applying of any such articles in the conduct of any drug place of business.
(p) Minimum standards. All charitable drug donors not engaged in manufacturing, processing, packing, or holding of drugs shall comply with the minimum standards specified in subsection (q) of this section as it applies to the firm's operations, and to the existing statutory standards contained in the Health and Safety Code, Chapter 431. All charitable drug donors engaged in manufacturing, processing, packing, or holding of drugs shall comply with subsections (q) and (r) of this section as it applies to the firm's operations, and to the existing statutory standards contained in the Health and Safety Code, Chapter 431. For the purpose of this section, the policies described in the United States Food and Drug Administration's Compliance Policy Guides as they apply to drugs shall be the policies of the department.
(q) Current good manufacturing practices in manufacturing, processing, packing, or holding of drugs by drug manufacturers.
  (1) The department adopts by reference Title 21, CFR, Part 210, §§210.1 - 210.3, titled "Current Good Manufacturing Practices in Manufacturing, Processing, Packing, or Holding of Drugs"; and Part 211, §§211.1 - 211.208 entitled "Current Good Manufacturing Practice for Finished Pharmaceuticals," as those regulations apply to any building under the control of a drug manufacturer where drugs are manufactured, processed, packaged, or held.
  (2) Copies are indexed and filed in the office of the Drugs and Medical Devices Group, Texas Department of State Health Services, 1100 West 49th Street, Austin, Texas 78756 and are available for inspection during normal working hours.
(r) Requirements for charitable drug donors.
  (1) The department adopts by reference Title 21, CFR, Part 205, §§205.1 - 205.50, 1994, as amended, entitled "Guidelines for State Licensing of Wholesale Prescription Drug Distributors," for prescription drugs, and all charitable drug donors are subject to and must comply with these regulations.
  (2) Copies are indexed and filed in the office of the Drugs and Medical Devices Group, Texas Department of State Health Services, 1100 West 49th Street, Austin, Texas 78756 and are available for inspection during normal working hours.
  (3) Prescription drug means any drug, human, or veterinary, required by federal law or regulation to be dispensed only by a prescription, including finished dosage forms and active ingredients subject to the Federal Food, Drug, and Cosmetic Act, §503(b).
  (4) Legend drugs. A charitable drug donor shall not possess, sell, or transfer drugs whose labels bear the legend "Caution: Federal law prohibits dispensing without prescription" or "Rx Only," unless that person is authorized to possess, sell, or transfer such drugs in compliance with the Health and Safety Code, Chapter 431, Texas Food, Drug, and Cosmetic Act, Subchapter I; and the Health and Safety Code, Chapter 483, Texas Dangerous Drug Act.

Source Note: The provisions of this §229.25 adopted to be effective May 29, 2003, 28 TexReg 4153; amended to be effective December 9, 2010, 35 TexReg 10755