Probably a stupid question about filling controls

[beautifulrobot]

Say you are in an outpatient pharmacy setting (federal, so you don't care about state laws), and you are processing a refill for a controlled substance (CIII-CV). The prescription is about to expire in a few days, but you do not have the medication in stock, and you will only have the medication in stock a day or two after the prescription expires. If you process the refill before the prescription expires, can you still legally dispense it after the prescription expires (again, taking into account federal law only)? Lets also say it would not be feasible to transfer this prescription to a different pharmacy without causing undue burden to the patient, and for all intents and purposes, you have no clinical concerns and no concerns about abuse/misuse/diversion.

My understanding is that the Controlled Substances Act says that you cannot dispense a Schedule III-V controlled substance 6 months after the date the prescription was written (well, it clearly states this in the context of partial refills, anyway). Does the fact that you process the refill, but cannot actually dispense it because the medication is out of stock, change anything, or does the 6 month rule still hold in this case?

I realize the "easy" answer is to just request a new prescription from the provider, but for the sake of argument, does the law clearly say "no" or is there some ambiguity here?

---

Members don't see this ad.

 

[waiter]

They will need a new prescription or, as you suggested, transfer the prescription.

 

[lord999]

It's pretty obvious.

Title 21 CFR - Part 1306 - Section 1306.22 Refilling of prescriptions

1306.22A


The weird part is the partials rule, where in the old days, a partial counted as a fill, but apparently inspectors don't consider it that anymore.

 

[beautifulrobot]

I guess the part that is potentially ambiguous is whether the phrasing "filled or refilled" subsumes "dispensed to the patient" - so if I print out the label for the refill on Date X (prior to the prescription expiration), but the medication isn't ready for pick up or the the patient doesn't pick up the prescription until Date Y (after the prescription expires, and lets assume again that it is just one or two days after the prescription expires), am I still violating the law by dispensing the medication?

When you look at the documentation required under 1306.22C, the date the patient picked up the medication is not specified, which would lead me to believe that the DEA wouldn't necessarily audit the pick up date, and may not care, unless again, there was some kind of egregious discrepancy between the fill date and the pick up date that could raise other concerns.

eta: Granted, if there is ever a question about the law, one should always interpret it as prudently as possible, so the right answer in this situation is no, one shouldn't dispense the expired prescription to the patient, even if the fill was processed prior to the prescription expiring. Though I still think there might be some room for argument here.

 

[lord999]

I guess the part that is potentially ambiguous is whether the phrasing "filled or refilled" subsumes "dispensed to the patient" - so if I print out the label for the refill on Date X (prior to the prescription expiration), but the medication isn't ready for pick up or the the patient doesn't pick up the prescription until Date Y (after the prescription expires, and lets assume again that it is just one or two days after the prescription expires), am I still violating the law by dispensing the medication?

When you look at the documentation required under 1306.22C, the date the patient picked up the medication is not specified, which would lead me to believe that the DEA wouldn't necessarily audit the pick up date, and may not care, unless again, there was some kind of egregious discrepancy between the fill date and the pick up date that could raise other concerns.

eta: Granted, if there is ever a question about the law, one should always interpret it as prudently as possible, so the right answer in this situation is no, one shouldn't dispense the expired prescription to the patient, even if the fill was processed prior to the prescription expiring. Though I still think there might be some room for argument here.

In the situation you just named, no one in the HHS inspectorate would make an issue of it, and no ALJ would take this as a hearing even if there was someone that stupid because the circumstances are clearly such that the liberal interpretation would be in the patient's benefit. Of course, if this is a BoP facility, there are house rules about you not doing that due to the style of dispensing anyway. Furthermore, DoJ (meaning DEA) actually DOES NOT have jurisdiction and specifically have no primary investigation authority within a federal clinic by agreement with HHS anyway, so you wouldn't have some DEA CHIMPS ("completely hopeless in most policing situations") breathing down the your neck.

 

[zelman]

It is not technically okay to process or fill the prescription before it expires and have the patient pick it up after it expires, as the "pick up" is the "dispense" as far as I am familiar with the law (which may or may not be accurate). However, because the time from fill to pick up is typically a very short window, people don't tend to keep track of this in situations where there is no law directly addressing it (example: CII Rx in Hawaii must be filled within 7 days of being written and picked up within 7 days of being filled).

 

[BidingMyTime]

Hmmm, good question. I always thought the law was just in regard to "fill by", not "picked up by". If not, it seems like there would be a lot of enforcement questions (ie what about a mail order pharmacy that filled & mailed the prescription out on time, but the mail was delayed and the patient didn't get it in their mailbox until after the date.....or one of those kiosk pharmacies, what if the medicine was still on-time when the pharmacy left, but then after midnight the date is up, but the patient comes and picks it up before the pharmacy opens back up?)

I've never heard of anyone getting in trouble for this, or the DEA checking to see when prescriptions were sold, so is would seem the DEA's intention is "fill by", not "picked up by."

 

[beautifulrobot]

In the situation you just named, no one in the HHS inspectorate would make an issue of it, and no ALJ would take this as a hearing even if there was someone that stupid because the circumstances are clearly such that the liberal interpretation would be in the patient's benefit. Of course, if this is a BoP facility, there are house rules about you not doing that due to the style of dispensing anyway. Furthermore, DoJ (meaning DEA) actually DOES NOT have jurisdiction and specifically have no primary investigation authority within a federal clinic by agreement with HHS anyway, so you wouldn't have some DEA CHIMPS ("completely hopeless in most policing situations") breathing down the your neck.

Gotchya. I didn't realize that DoJ actually does not have jurisdiction, but that makes sense. I figured that the answer to this question within a federal pharmacy (and the situation in which this came up for me is in an MTF pharmacy, which is even more loosey goosey when it comes to the rules anyway, and I assume DoJ doesn't have jurisdiction within DoD as well) is that 1) it isn't something that should be done on a regular basis but 2) it isn't a "hard" violation of the rules unless there is a specific in-house rule against it. Nonetheless, I just try to think about and keep in mind how the laws work in the "real world" in case I find myself in a civilian pharmacy one day...

 

[lord999]

Gotchya. I didn't realize that DoJ actually does not have jurisdiction, but that makes sense. I figured that the answer to this question within a federal pharmacy (and the situation in which this came up for me is in an MTF pharmacy, which is even more loosey goosey when it comes to the rules anyway, and I assume DoJ doesn't have jurisdiction within DoD as well) is that 1) it isn't something that should be done on a regular basis but 2) it isn't a "hard" violation of the rules unless there is a specific in-house rule against it. Nonetheless, I just try to think about and keep in mind how the laws work in the "real world" in case I find myself in a civilian pharmacy one day...

Actually, it is a little different for DoD and even easier. DoD summarily dismisses the rules on those matters for uniformed treatment facilities for the good order. It would be the Command Surgeon's authority against the Provost Marshal, and the Provost Marshal would never challenge it for something like this (also since you're an officer yourself, the IO's are E-5/E-6 at most). What would happen if someone had an issue is that the Command Surgeon would cite longstanding precedent in ASD(HA) about intent to treat, then issue any covering paperwork authorizing the variance. I've actually seen variances as wide ranging as keeping non-FDA approved drug formulations (the sore throat lidocaine spray before it was available in the US, because the Landstuhl personnel loved the French formulation) and as petty as "ignore this guy who took the box of methamphetamine from supply and shared with his buddies, they were needed for some small operation" when we were auditing the warehouse and found that we were short a full box of the stuff (some 4,000 doses). Your officer authority would definitely shield you from these sorts of petty issues, and you don't have to be rude about it as you can honestly say that it's one of ours and it was a logistics failure that didn't need anyone but your command override in the first place.

 

[RxPreceptor]

Some chains implement the more stringent interpretation of not being able to pick up controls once expired based on date of issue (Rx will be blocked at the point of sale & the Rx will appear on the RTS list).

 

[ChalupaBatman86]

Some chains implement the more stringent interpretation of not being able to pick up controls once expired based on date of issue (Rx will be blocked at the point of sale & the Rx will appear on the RTS list).

I can picture it. You start to ring it up and then dangle it in front of them just out of their reach and say, "aww, you should have been a little bit quicker!"


Sent from my iPhone using SDN mobile

 

[zelman]

I can picture it. You start to ring it up and then dangle it in front of them just out of their reach and say, "aww, you should have been a little bit quicker!"


Sent from my iPhone using SDN mobile

Well, we do it with Accutane.