Pharmacist Instructing To Reuse Single Dose Testosterone Vials

Answer

Thanks for reaching out, and I am sorry to hear about this situation. I can only imagine how frustrating it is when your doctor, your pharmacist, and the manufacturer of the testosterone vials are giving conflicting information.

It's clear to me that the dispensing pharmacist is not correct in this case. Even though it may seem reasonable to reuse a vial of testosterone labeled 'Single Dose', especially if it contains preservatives and the same ingredients as the larger multi-dose vial, it should not be done.

Under FDA and USP standards, ‘Single Dose’ is not just a label or recommendation; it is a binding classification with a definitive definition. By definition, 'Single Dose' means the manufacturer has not validated the vial for multiple punctures or repeated use. That is why anything left over after one dose must be discarded.

If you stopped reading here, let me leave you with this: Your doctor and the manufacturer’s guidance are correct. Single dose vials should not be reused. You should work with your pharmacy to obtain the multiple dose product or the appropriate number of single use vials that match your injection plan.

What 'Single Dose' Means

Under FDA and United States Pharmacopeia standards, a Single Dose Vial is a container intended for use in one patient for one injection or infusion and then discarded. If you're curious, here is a link to an FDA resource on the matter (https://www.fda.gov/media/117883/download). Per the FDA, a 'single dose container' is defined as:

Single-Dose Container: A single-dose container is a container of a sterile medication for parenteral administration (injection or infusion) that is not required to meet the antimicrobial effectiveness testing requirements. A single dose container is designed for use with a single patient as a single injection/infusion.

It's important to point out that:

• Single dose containers are not required to prove that their preservative system prevents contamination with repeated entries.
• The stopper and closure on single dose containers are not validated for multiple punctures and resealing.

What 'Multiple Dose' Means

A Multiple Dose Vial is specifically designed, tested, and labeled for repeated withdrawals.

• Multiple dose containers must contain an antimicrobial preservative and pass USP 51 antimicrobial effectiveness testing on the final product in its package.
• The closure on multiple dose containers is validated to reseal after multiple punctures.

Testosterone Cypionate Vial Confusion

Testosterone Cypionate is available as both a 1 mL Single Dose vial and a 10 mL Multiple Dose vial. For both of these products, the ingredients look exactly the same (for example, one specific testosterone product from the manufacturer 'Cipla' comes in a 1mL single use and 10mL multi use vial, and both contain benzyl alcohol, benzyl benzoate, and cottonseed oil). The key point is that the presence of the same ingredients and preservatives does not make a product multi dose by itself.

Multi dose status depends on studies and validation of the exact package and closure per FDA and USP requirements. If those studies were not performed, the product must be labeled 'Single Dose' and any remaining medication must be discarded after the first entry.

Additional Thoughts

It is certainly possible that using a single dose vial of testosterone multiple times would not cause issues. From what I can tell, the ingredients in these different testosterone products (1mL vs. 10mL) are the same and in the same proportions. However, I do not know about potential differences in manufacturing of the vials, materials used in the stoppers, etc., that could cause problems.

It all comes down to the fact that single dose vials have not been tested according to USP and FDA standards for use beyond one dose. This includes specific microbial testing.

I cannot say whether the manufacturer chose not to test these smaller vials for multiple use, whether they failed such testing, or whether there are physical differences in the vials or manufacturing processes that make them unsuitable. What is clear is that the pharmacist’s claim they can be reused based only on the ingredients is incorrect since the product is labeled “Single Dose.”

The manufacturer, when contacted, will always cite the FDA-approved labeling of the product and USP standards. For these testosterone vials, their response is what I would expect: single use means just that, single use.

As for why the pharmacist at your pharmacy is insisting on reusing single dose vials, I can’t say for certain. Maybe they are misinformed, or perhaps they are being overly cautious about dispensing amounts since testosterone is a controlled substance. I don’t know the exact reason, but what is clear is that they are not correct in this case.

My Recommendation

1. Ask the pharmacy to dispense the appropriate amount of single use vials or a multiple dose vial that is actually labeled as such.
2. Ask to speak with the pharmacist in charge or the store manager if you are told to reuse single dose vials. If your pharmacy cannot supply the multiple dose vial, consider transferring the prescription to one that can.
3. If the issue continues, you can contact your State Board of Pharmacy. Hopefully it will not come to that, but pharmacists are expected to follow FDA labeling and USP standards.

Final Words