Frequently Asked Questions – Prescription Drug Distributors
Prescription drug distributors must operate in compliance with rules found in 25 Texas Administrative Code (TAC), Sections 229.419 - 229.430 - Licensing of Wholesale Distributors of Prescription Drugs; Including Good Manufacturing Practices. Section 229.420 of these rules adopts by reference certain federal laws and regulations applicable to prescription drug distributors, including the requirements in Title 21, Code of Federal Regulations (CFR), Part 205, Guidelines for State Licensing of Wholesale Prescription Drug Distributors.
Inspections of prescription drug distributors generally include an assessment of a distributor’s level of compliance with 21 CFR, Part 205. Below are some examples of frequently asked questions encountered during these inspections.
What written policies and procedures am I required to maintain?
Prescription drug distributors are required to establish, maintain and adhere to all written policies and procedures required in 21 CFR, Part 205 - Section 205.50(g). Among these are policies and procedures for the receipt, security, storage, recall, inventory (including correcting all errors and inaccuracies), and distribution of prescription drugs (e.g., stock rotation; identifying, recording, and reporting losses or thefts; and disaster preparedness).
Is my facility required to have a temperature monitoring device?
According to 21 CFR, Part 205 – Section 205.50(c), “All prescription drugs shall be stored at appropriate temperatures and under appropriate conditions in accordance with requirements, if any, in the labeling of such drugs, or with requirements in the current edition of an official compendium, such as the United States Pharmacopeia/National Formulary (USP/NF).” Therefore, you should check the drug labeling for any temperature requirements and, according to Section 205.50(c)(2), if there are requirements, “Appropriate manual, electromechanical, or electric temperature and humidity recording equipment, devices, and/or logs shall be utilized to document proper storage of prescription drugs.”
Is my facility required to have an alarm system?
According to 21 CFR, Part 205 – Section 205.50(b)(2), “All facilities shall be equipped with an alarm system to detect entry after hours.”
What do I do with expired and/or damaged drug products?
According to 21 CFR, Part 205 – Section 205.50(a)(3), “All facilities at which prescription drugs are stored, warehoused, handled, held, offered, marketed, or displayed, shall have a quarantine area for storage of prescription drugs that are outdated, damaged, deteriorated, misbranded, or adulterated, or that are in immediate or sealed, secondary containers that have been opened.”
Who can possess a prescription drug?
Health and Safety Code Chapter 483, Texas Dangerous Drug Act, designates the following persons as authorized to possess a dangerous drug:
- Pharmacies licensed by the Texas State Board of Pharmacy
- Practitioners (for example: medical doctors, dentists)
- Persons who obtain a dangerous drug for lawful research, teaching, or testing, but not for resale
- Hospitals that obtain a dangerous drug for lawful administration by a practitioner
- Officers or employees of the federal, state, or local government
- A manufacturer or wholesaler licensed by the Department of State Health Services under Chapter 431 (Texas Food, Drug, and Cosmetic Act)
- Carriers or warehousemen
- Home and community support services agencies licensed under and acting in accordance with Chapter 142, Health and Safety Code
- Documented midwifes, (Oxygen U.S.P. only) for use in deliveries; and
- Persons with a prescription drug, dispensed by a pharmacist, pursuant to a valid prescription
If my facility distributes medical gas cylinders, am I required to separate my full cylinders from my empty cylinders?
Yes. According to 21 CFR, Part 205 – Section 205.50(a)(1), “All facilities at which prescription drugs are stored, warehoused, handled, held, offered, marketed, or displayed, shall be of suitable size and construction to facilitate cleaning, maintenance, and proper operations.” Further, 21 CFR, Part 205 -- Section 205.50(a)(4) states that the facility will "be maintained in a clean and orderly condition." To facilitate proper operations and orderly conditions, your firm must segregate full cylinders from empty cylinders and industrial gases from medical gases if applicable.
What if I also distribute medical devices, such as nebulizers, catheters, and oxygen concentrators? Do I need an additional license?
Yes. If your firm distributes medical devices in addition to prescription drugs, you will need a license to distribute the devices. If the prescription drugs you distribute are restricted to medical gases only, you may be eligible for a Multiple Products License. Please visit our Drug Manufacturers and Distributors Licensing Requirements page for more information on Multiple Products Licenses. If you distribute prescription drugs other than medical gases and are interested in becoming licensed as a device distributor, please visit our Medical Device Manufacturers and Distributors Licensing Requirements page.