Questions About Controlled Substance Fill Dates

Hi Vickie, thanks for reaching out!

There are a few things to consider for your question:

• What are the applicable laws for filling controlled substances (specifically, fill dates and the drug ordering process around this)
• The rules and policies of your particular pharmacy
• The rules and policies of your prescriber

Let's touch on these each separately, starting with the laws around your situation.

Laws Around Early Filling Of Controlled Substances

I know you're not technically asking about early refills, but you want to know what the law is regarding the date of fill (or refills).

Federal law (i.e. from the DEA and FDA) doesn't actually much touch on early refill policies, or filling dates in general. While they do give guidance from time to time (Guidance on Controlled Substance Prescription Refills), the DEA leaves it to the individual States to provide applicable rules and regulations:

Subject to the provisions of 21 CFR 1306.06, requiring a pharmacy only to dispense controlled substances in the usual course of professional pharmacy practice, and if the prescription meets the requirements of 21 CFR 1306.04(a), this practice may be permitted if the early dispensing is allowed by state law and regulation

So, to answer your question most accurately, the State you are located in is extremely important.

Let's use New York State for example. New York State law states that a pharmacy/pharmacist can dispense a controlled substance prescription to a patient as long as they have no more than a 7 day supply on hand. This is informally known as the '7 day rule'. The law reads:

No additional prescriptions for a controlled substance may be issued by a practitioner to an ultimate user within 30 days of the date of any prescription previously issued unless and until the ultimate user has exhausted all but a seven days' supply of that controlled substance provided by any previously issued prescription.

Now, even though the law allows for a pharmacist in New York State to dispense a controlled substance prescription early (based on the above regulation), that doesn't mean that they are required to.

They are still allowed their professional judgement as they have a professional responsibility to deter potential abuse, misuse and diversion of controlled substances.

Pharmacy Policies

In addition to the rules of regulations of your particular state regarding the dates of controlled substance fills, your particular pharmacy (or pharmacist) may have specific rules in place.

It's certainly not uncommon that a pharmacy chain has policies that restrict the early filling of controlled substances for all their patients (outside extenuating circumstances), even if a fill date (or early fill date) is within the legal bounds.

It is best to check with your individual pharmacy/pharmacist for their policies.

Prescriber Policies

Lastly, in addition to the State laws and policies of your pharmacy, your prescriber (e.g. doctor, nurse practitioner etc...) may have their own policies regarding the filling of controlled substance prescriptions they write.

For example, most prescribers that treat chronic pain patients require these patients to sign some sort of contract (such as a prescriber-patient opioid agreement) that specifically states when controlled substance prescriptions can be filled (or refilled).

Additionally, many prescribers, when they have a patient they consistently prescribe controlled substances for, will notate on the prescription that it can be filled a certain date, even if it is more strict than the State law. It is extremely unlikely your pharmacy would fill your prescription before the date the prescriber annotates, without contacting them first.

Can Pharmacies Order Controlled Substances Before They Are Due To Be Filled?

I wanted to touch on this point you brought up, as you mentioned your pharmacy holds you to a certain fill date, but then never has the drug in stock on that fill date.

There is no law stating a pharmacy cannot order a controlled substance drug before a scheduled fill date.

The fact that your pharmacy never has your drug in stock is completely on the management/inventory planning side of things.

It certainly may be the case that they don't normally stock the drug you take, but there is little from stopping them to order that drug in before hand to have available on your fill date.

I do know that many pharmacies won't order a drug until they have a prescription in hand, but you mentioned your prescription is sent to the pharmacy many days ahead of time.

I imagine the issue with your pharmacy is that they don't want to order the drug until they are able to ensure it goes through your insurance.

I won't get into the weeds here regarding how prescriptions are billed, but generally, prescriptions are only billed to your insurance when they are in the process of being dispensed. So, I'm guessing your pharmacy is getting your prescription, 'holding it' until the scheduled due date, and then billing it to the insurance. Since they are billing it on your due date, that's the time in their process where they check drug inventory.

Some pharmacies are better at inventory management, and forecasting needs, than others. Your situation isn't a surprise to me, but I'm sure you could find a pharmacy that is more accommodating in this regard.

Your Questions

You asked very specific questions in your submission to us, so I want to answer those directly.

Question One

Q: Is it the LAW that a pharmacist cannot FILL a prescription before day 31, or is it they cannot DISPENSE it till day 31?

A: No, in general, as I wrote about in the 'laws' section of this answer, the law varies by State, but most allow for some sort of early dispensing for controlled substances (e.g. the '7-day rule in New York State).

It sounds like your pharmacy is holding you to the date you are 'due' for your medication (i.e. the day you would have no doses left, which would be the 31st day if you usually get a 30 day supply).

You make a distinction between fill date and dispense date. A more accurate way of defining these terms would be fill date and pick-up date. The fill date is the date that your pharmacy physically fills your prescription. This is the date that would be on your pharmacy label that adheres to your bottle/package etc...

Of course, just because a pharmacy fills your prescription a certain date, doesn't mean it is picked up on that same date, so these dates can certainly be different.

In regard to which of these dates your pharmacy will use to determine when you are due for your prescription, the answer is unfortunately a little cloudy.

It should be the pick-up date since that is the best indicator of how much supply of a prescription someone actually has on hand. However, most of the time, it is actually the fill date. This is mainly due to how pharmacy and reporting systems work.

The fill date of a controlled substance prescription is captured everywhere...in the pharmacy software, by your insurance company, by state prescription monitoring programs (as most states have for controlled substances).

The pick-up date is generally not captured everywhere. While your local pharmacy has a record of this, oftentimes, this date is not transmitted to your insurance company, to other pharmacies and only rarely is it required to be reported to state prescription monitoring programs.

To give an example here, if you usually go to CVS to fill a controlled substance prescription, but one month you decide to go to Walgreens, Walgreens would really only have access to your last fill date (either through communication with your insurance or through the record in the prescription monitoring program). Therefore, they would base your due date on the information they have available (which is the last fill date).

Question Two

Q: Is this a hard fast rule where you would go to jail if you break it law, or does the law allow the pharmacist some discretion to make allowances for a few days for extenuating circumstances?

A:  This question has been answered based on what I have written thus far. The law really varies by state but generally there is room for discretion/extenuating circumstances regarding early refills for controlled substances. It really all comes down to the laws in your state, rules/policies of your pharmacy and the rules/policies of your prescriber.

Final Words

I hope this answer helped! Please reach out again if needed. Always more than happy to help out.