10ml Testosterone Vials – Endangered Species?

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  • testosterone cypionate 10ml and 1ml vials

A quick question for fellow U.S. readers out there. Has this happened to you recently? You walk out of the doctor’s office with your usual prescription. A quick check to make sure everything is the same. In the middle of the barely-legible-doctor-scribble you make out “testosterone cypionate”, “200”, and “10”. Two refills. Three 10ml bottles should last you 6 months. Everything looks good. You drop it off at the pharmacy, only to hear “wait a minute” as you are walking away. “We can’t fill this”, says the pharmacist. There’s a 28-day rule. We need to switch you to 1mL vials. Here are 4. Come back next month. You’ve been filling the same prescription for years. What gives?

It seems pharmacists are more actively following a rule clarification that came down from the FDA several years ago. It is called the “28-day rule”. It states that any sterile injectable vial must be discarded within 4 weeks after it has been punctured (exposed to air and bacteria) for the first time. Note that some solutions may have longer or shorter shelf lives after first use. Such information must be presented on the product packaging, however. Otherwise, the 28-day rule applies. The healthcare accreditation origination The Join Commission explains the reasoning behind the FDA rule in the following statement.

“Multi-dose vials are to be discarded 28 days after first use unless the manufacturer specifies otherwise (shorter or longer). Manufacturers are only required by law to test the effectiveness of the bacteriostatic agent used in the multi-dose vial for a period of 28 days. Manufacturers are allowed by the FDA to provide extended dating in the package insert if they have conducted testing beyond the 28 days. Multi-dose pens, such as those used to inject medications such as insulin and Byetta, are included.”

Simply put, 4 weeks is the standard threshold that the pharmaceutical companies are required to meet in testing. They can’t guarantee sterility beyond that. The 28-day rule is, likewise, an important safety measure. The use of preservative agents in injectable solutions generally doesn’t protect them from bacterial contamination completely. They slow development, not eliminate it. Bactera can actually grow in these vials just fine, albeit more slowly in comparison to most water-based solutions. Case in point, the most bacteria-laden steroid vial I ever sent to an analytical lab was a vial of oil-based testosterone that had been punctured months earlier but not completely used.

This change is a concern for many U.S. patients. Using these smaller 1mL vials considerably increases the overall cost of medication, especially if paying out of pocket. Typically, we’re seeing the cost of four (4) 1mL vials of testosterone cypionate running about the same as a single 10mL vial. That’s roughly $100 at the pharmacy! Therefore, this switch in prescription can represent an increase in the cost of treatment by 2.5 times, overnight. It also seems there would be little incentive to continue making 10ml vials, as they provide simply too much hormone for the 28-day rule. Granted, using a 10mL vial for 10 weeks is quite a stretch. I wouldn’t argue it is always safe. Still, many have been doing it without issue, and are quite upset at the recent cost increase. It is of note that this rule goes back years. It just seems that lately, some of the pharmacies, particularly some of the larger chains, are being more active at enforcing it.

What has been your experience? Anyone else recently have to switch to 1ml vials?

By | 2017-04-07T01:10:38+00:00 May 16th, 2015|Categories: Topics: Steroids|12 Comments

About the Author:

William Llewellyn is a researcher in the field of human performance enhancement. He is also author of the bestselling ANABOLICS book series, most recently the ANABOLICS 10th Edition. William is an active supporter of the harm reduction community, and currently serves as honorary lecturer at the Centre for Public Health at Liverpool John Moores University.

12 Comments

  1. AftermarketMesomorph May 19, 2015 at 6:28 pm - Reply

    The pharmacy tried to give me a refill with 1 mL vials last time. They said it was due to my insurance not allowing them to fill more than 30 days of a prescription. I complained and said that the brand they were filling it with did not work as well for me as Actavis (née Watson). I also called my insurance company to get the change approved. Since Watson only manufactures 10 mL vials, so there if you get Watson it will have to be a 10 mL vial.

    Luckily the pharmacy and my insurance didn’t do any research. Both Actavis/Watson and the other brand are manufactured by Hikma.

    It was a hassle, but in the end I was able to get a 10 mL vial.

  2. Jb May 22, 2015 at 2:35 am - Reply

    Yup and it sucks! I now pay the same for way less and it sucks! But the pharmacist said if at walgreens print off a good rx coupon and it drops the total cost down by half if not more and i can pay out of pocket about $45-55 per month for the full 10ml…. Im gonna try what the guy above did!!

  3. T-Diddy June 2, 2015 at 12:21 am - Reply

    Up here in Canada, just got prescribed Testosterone Enanthate – Was quite surprised to receive a 5ml bottle at a mere $14. Prescribed 1ml/200mg – biweekly injections, that said, will last 10 weeks.

  4. Richard Katzman September 15, 2015 at 12:01 pm - Reply

    I ml Testosterone vial too small to handle with arthritis? I turned a piece of wood that holds the vial so that arthritis suffers can hold the vial while filling it with a syringe. Makes it much easier to hold!

  5. […] ml vials. I asked my TRT doc and he pointed me to them. You may want to ask your doc as well. This may explain why. It seems pharmacists are more actively following a rule clarification that came down from the […]

  6. 1mL bottles instead of 10mL??? February 16, 2016 at 11:36 pm - Reply

    […] Testosterone Cypionate Intramuscular Injection And this about the 10mL bottles becoming rare… 10ml Testosterone Vials – Endangered Species? – Anabolic.org Reply With […]

  7. Ron Czesztyicki May 15, 2016 at 2:50 am - Reply

    I been on 10 ml vials for for years. If there is a 28 day shelf life to 10 ml testosterone cypianate. How come my blood work is good 1ml every 2 weeks? After 6 months ?What am i missing here? The money aspects?

  8. Ron Czesztyicki May 15, 2016 at 3:03 am - Reply

    What can we do? I got a script for 10 ml vials ?

    • Theo Dubuios September 25, 2016 at 7:46 pm - Reply

      Go to meso-rx, or thinksteroids.com. Trust me they will help you immeasurably

  9. Tim McCoy May 27, 2016 at 12:56 am - Reply

    I get a 140 day supply of 10 ml bottles for $44 at Walgreens.

  10. Clint Hampson September 10, 2016 at 2:34 am - Reply

    They did me the same way. I used to get 10ml every 2 1/2 months and could inject 200/wk when only prescribed 200/ every other week. Now I only get 2 of 1ml per month. I’ve been working.out lately and luckily I can get 10ml of Watson for $100. Cost is about the same as 1ml bottles with insurance but at least I can control my dose.

  11. Theo Dubuios September 25, 2016 at 7:42 pm - Reply

    Go to meso-rx forum at thinksteriods.com. They help uninsured patients find discount offers and promotional offers assisting in HRT and the often expensive anti-aging prescriptions and other health benefits. Comparing prices with reputable pharmacies and the recently approved pharmaceutical charity based companies domestic and abroad, and finding the cheapest. If it’s not within 50 miles of your location, they will have it shipped to you and even cover shipping! I’ve been on HRT for a year now and I don’t know what I would have done without the support and the help from not only the moderators but the hundreds of people sharing their experiences.. and it’s not some bullshit you gotta pay for, its a forum it’s free! With people like us that can’t afford to pay out of pocket to these greedy pharmaceutical manufacturers.. Like the epiPen atrocity.. Go just see what it’s about. Ask for help and you’ll have 20 people offering they’re experiences and feedback.. The forums have diet and exercise guidance and you can tell your story or read countless others.. I’m not a damn rep I promise you.. Nobody makes anything except knowledge.. I just happened upon this article, and though it’s old it’s still relevant.. I haven’t seen a 1ml vial in 8 months.. It’s outrageous.. Just had to rant because the big pharm don’t want you to know about your options.. They’re goin straight to hell at 100mph and laughing all the way.. Sorry..

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