Texas Board of Pharmacy has proposed amendments to its current regulations of the temperature storage of medications by mail. This is a major advancement. Still, a gray area that will risk patients' lives exists. If you're a Board of Pharmacy member reading this, please know we appreciate your work. 

Please share comments in support of temperature regulation. Mostly, it is the mail order pharmacies that comment. Let's make this time different.

If you can't afford or do not have access to fax but want your voice to be heard, you may email your comments to loretta@uniteforsafemeds.com, and I will fax them for you at your request. 

The slightest comment, such as "I support proper temperature storage of medications by mail," or sharing why this issue is important to you or a personal experience, will be helpful as this may be one of the greatest uphill grassroots fights in our nation. 

Otherwise, written comments on the proposed rule may be submitted to Eamon D. Briggs, Deputy General Counsel, Texas State Board of Pharmacy, 1801 Congress Avenue, Suite 13.100, Austin, Texas 78701-1319, FAX (512) 305-8061. Comments must be received by 5:00 p.m., July 24, 2023.

For those who want further insight, below are my thoughts on the proposed rule. Remember that I’m just a passionate mom learning to navigate this complex regulatory system, but you may use any of my comments in yours.   

Texas Proposed Rule §291.12. (1)Delivery of Prescription Drugs 

"Standards. The pharmacy shall ensure that all prescription drugs are delivered to the patient or patient's agent in accordance with standards of the manufacturer or the United States Pharmacopeia (USP)." 

My Comments: 

#1. USP's guidelines are mostly the temperature guidelines you see on your label and more protections. This proposed rule must further state the exact general chapters of USP, that the mail order pharmacies should be required to follow USP 659 as this is the rule that USP states mail order pharmacies should adhere to.

Why is this important? Without direction to the exact USP guideline, the mail order pharmacies can claim that they are referring to any USP chapter. 

#2. The sensors or temperature tracking is proof that patients need to ensure that their medications are safe to ingest and must be required for all medications shipped by mail. Sensors generally cost pennies.

Why is this important? Most manufacturers do not have evidence or testing that shows that any medications, especially room temperature medications, are safe up to 170 degrees that many trucks and mailboxes reach as most are stored in only a bag. Some drug manufacturers refuse to provide additional stability testing to State Boards, let alone to patients.  Testing at temperature extremes is not required, and most will not test medications at that extreme because it is known that medications will break down. 

Texas proposed rule §291.12. (3) "The pharmacy shall ensure the integrity of any prescription drug requiring temperature control other than "room temperature" storage as defined in §291.15 of this title (relating to Storage of Drugs) that is delivered by mail. The pharmacy shall use temperature tags, time temperature strips, insulated packaging, gel ice packs, or a combination of these as necessary."

 This rule is a great start, but we urge the Texas Board of Pharmacy to include room temperature medications and more direct language about ensuring safe temperature storage to protect the integrity, such as Oklahoma's regulation requiring proper packaging and safe storage of medications by mail. We also suggest that the Boards audit the pharmacies and ensure they are correctly packaging medications safely. 

"The pharmacy shall maintain and use qualified packaging systems and/or devices with adequate storage or shipment containers and use shipping processes to ensure drug stability and potency. Such shipping processes shall include using qualified packaging systems, appropriate packaging material, and/or devices to ensure that the drug is maintained at an appropriate temperature range to maintain the integrity of the medication throughout the delivery shipping process."

#3. Additionally, Oklahoma regulation that requires patients to have the contact information for the Board of Pharmacy on every package. This is critical as most don't know the Boards of Pharmacy exist or where to file a complaint.

A side note: As mentioned in this NBC report, it was brought to the attention of the Oklahoma Board of Pharmacy by CVS Lobbyists, who spoke against temperature regulation, that CVS has received medications that are hot to touch from manufacturers and wholesalers. This should alarm anyone forced to mail order. Medications these pharmacies receive may be degraded and damaged further by improper temperature storage during transit by mail. 

The FDA regulates manufacturers and wholesalers, not the State Boards. CVS is receiving medications hot to the touch, and that may be degraded. In that case, they should not be able to further risk patients’ lives by forcing patients to their own mail order pharmacies and further allowing the drug to potentially be damaged by exposing the medications to temperature extremes once again. As this was brought to the Boards of Pharmacy’s attention, the FDA and State Boards should immediately investigate the safety of medications received and shipped by CVS pharmacies. 

You may email me loretta@uniteforsafemeds.com with your direct thoughts on this proposed rule. 

Thank you for your support, 

Loretta Boesing, Patient Advocate

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