30 day limits per fill for C-III drugs and patient access issues

[beautifulrobot]

I came across an interesting question from a friend up in Massachusetts, where state law limits schedule III controlled substances to a 30-day supply per fill (Section 23). Say you have a patient who has a real allergy to the cottonseed oil that testosterone cypionate is suspended in, so they are prescribed testosterone enanthate (suspended in sesame oil) 200 mg IM q2weeks. Testosterone enanthate is supplied in 5 ml multi-dose vials of 200 mg/mL only, so one vial of T enanthate exceeds the 30-day supply limit. Is the patient out of luck? Can the prescriber and pharmacist work it out where the prescription is written with a "discard remainder after 30 days" (which would also bring the prescription in compliance with USP standards), or would dispensing the 5 ml vial still violate the law?

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[zelman]

I came across an interesting question from a friend up in Massachusetts, where state law limits schedule III controlled substances to a 30-day supply per fill (Section 23). Say you have a patient who has a real allergy to the cottonseed oil that testosterone cypionate is suspended in, so they are prescribed testosterone enanthate (suspended in sesame oil) 200 mg IM q2weeks. Testosterone enanthate is supplied in 5 ml multi-dose vials of 200 mg/mL only, so one vial of T enanthate exceeds the 30-day supply limit. Is the patient out of luck? Can the prescriber and pharmacist work it out where the prescription is written with a "discard remainder after 30 days" (which would also bring the prescription in compliance with USP standards), or would dispensing the 5 ml vial still violate the law?

I would expect the smallest package size to be acceptable. When I was working in MA the 1mL vials of Test Cyp were on backorder for a while and we just filled the 10mL and documented it. I never heard much from the state on controlled substance issues there. The DEA seemed more involved, and the 30 day limit isn’t a federal issue.

 

[ldiot]

I came across an interesting question from a friend up in Massachusetts, where state law limits schedule III controlled substances to a 30-day supply per fill (Section 23). Say you have a patient who has a real allergy to the cottonseed oil that testosterone cypionate is suspended in, so they are prescribed testosterone enanthate (suspended in sesame oil) 200 mg IM q2weeks. Testosterone enanthate is supplied in 5 ml multi-dose vials of 200 mg/mL only, so one vial of T enanthate exceeds the 30-day supply limit. Is the patient out of luck? Can the prescriber and pharmacist work it out where the prescription is written with a "discard remainder after 30 days" (which would also bring the prescription in compliance with USP standards), or would dispensing the 5 ml vial still violate the law?

I would go with the discard remainder route since it's a multi-dose vial, but let the md know so that the pt doesn't run out of refills early.

 

[maria1oh]

I believe the fda or some other government agency issued a statement that all injections are only stable for 28 days. So 10ml vial expires after 28 days after first use.

Questions about Multi-dose vials | Injection Safety | CDC