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Pharmacist FAQs

Frequently Asked Questions for Pharmacists on Schedule II Controlled Substances


Q:  May I dispense partial fills of a Schedule II controlled substance prescription?

A:  Yes.  Under the Comprehensive Addiction and Recovery Act of 2016 (“CARA”), a pharmacy may provide a partial fill of a Schedule II controlled substance prescription if:  (1) state law does not prohibit partial fills of Schedule II prescriptions (North Carolina law does not prohibit partial fills of this sort); (2) the prescription is written and filled in compliance with federal and state law; (3) the partial fill is requested by the patient or the prescriber; and (4) the total quantity dispensed in all partial fills does not exceed the total quantity prescribed.


Q:  For how long may I provide partial fills of a Schedule II controlled substance prescription?

A:  In general, under CARA, the total amount of a Schedule II controlled substance prescription may be filled no later than 30 days from the date the prescription was written.

DEA rules have long allowed a Schedule II controlled substance prescription for a patient in a Long Term Care Facility, or a patient with a documented terminal illness diagnosis, to be dispensed by partial fills for up to 60 days from the date of the prescription.  There is nothing in CARA’s language that indicates an intent to change this long-standing rule.

If a pharmacist receives a verbal Schedule II controlled substance prescription pursuant to an emergency, the pharmacist may provide a partial fill, but must provide the remainder of the prescription amount within 72 hours.  After 72 hours, no further dispensing on the emergency prescription is allowed.  All other requirements regarding the need to receive a hard copy (or valid electronic) prescription within seven days remain.


Q:  I thought that I could only do a partial fill of a Schedule II prescription if the pharmacy is “unable to supply the full quantity” and that I had only 72 hours to provide the remainder of the prescription?

A:  Prior to CARA’s enactment in October 2016, DEA rules did so limit partial fills of Schedule II prescriptions.  CARA superseded DEA’s rules on this matter.



Changes to Prescriptions for Combination Products containing a Schedule II drug and Acetaminophen

Q: Can a pharmacist change or add the correct amount of acetaminophen to a prescription for a combination product containing a schedule II drug and acetaminophen?

A: Yes.  If a pharmacist receives a prescription for a combination product containing a schedule II drug and acetaminophen that appears to have a missing, incorrect, or unavailable acetaminophen dosage, the pharmacist may add or change the amount of acetaminophen written on the prescription after speaking directly with the prescriber and documenting the clarification on the prescription.


(a)  A prescriber writes for “Vicodin 5/325.”   As pharmacists know, Vicodin is now formulated as hydrocodone 5mg /acetaminophen 300 mg.  The pharmacist may call the prescriber to clarify which product was intended – e.g., Vicodin 5/300 or another hydrocodone 5 mg/acetaminophen product containing 325 mg of acetaminophen per dosage unit (see (b) below).   The pharmacist must document on the prescription the changes made after consultation with the prescriber.

(b) A prescriber writes for “Vicodin 5/325,” but the prescriber intended to write for Norco (hydrocodone 5 mg /acetaminophen 325 mg).  The pharmacist may change the brand name to match the correct combination product intended.  The pharmacist must document the clarification after consultation with the prescriber.


Q.  Doesn’t the Drug Enforcement Administration (DEA) prohibit the kind of clarifications described above?

A.  No.  DEA advises that “pharmacists are instructed to adhere to state regulations or policy regarding those changes that a pharmacist may make to a schedule II prescription after oral consultation with the prescriber. . . .[W]hen  information is missing from or needs to be changed on a schedule II controlled substance prescription, DEA expects pharmacists to use their professional judgment and knowledge of state and federal laws and policies to decide whether it is appropriate to make changes to that prescription.”




DRUG ENFORCEMENT ADMINISTRATION PLACES ALL HYDROCODONE CONTAINING PRODUCTS INTO SCHEDULE II EFFECTIVE OCTOBER 6, 2014.  On August 22, 2014 the federal Drug Enforcement Administration issued a final rule placing all hydrocodone-containing drug products into Schedule II. The rule is effective October 6, 2014.  Hydrocodone-only products already were Schedule II controlled substances.  This rule places all hydrocodone combination products into Schedule II.  The full text of the rule, including the DEA’s response to various concerns raised about the rescheduling is found here:

Some questions likely to arise:

  1. When is the rule effective?  The rule is effective October 6, 2014.
  2. Why did the Board of Pharmacy pass the rule?  The Board of Pharmacy did not pass this rule.  It is a federal rule passed by the Drug Enforcement Administration.  DEA’s explanation of the rule is found at the document linked above.
  3. What do I need to do with my inventory of hydrocodone-containing products?  Per requirements in the federal Controlled Substances Act, each DEA registrant pharmacy must conduct an inventory of all hydrocodone-containing products on October 6, 2014.  Pharmacies must maintain that inventory with all other controlled substance inventory records.
  4. What do I do about prescriptions for hydrocodone-containing products issued prior to October 6?  The DEA’s rule speaks directly to this issue:  “Any prescriptions for [hydrocodone-containing products] that are issued before October 6, 2014, and authorized for refilling, may be dispensed in accordance with [with the rules governing Schedule III prescriptions]  if such dispensing occurs before April 8, 2015.”  In other words, any refills authorized on a pre-October 6, 2014 prescription for a hydrocodone-containing products may be dispensed in accordance with the “no more than five refills within 6 months” requirement for Schedule III products.  But no refills of such prescriptions may occur after April 8, 2015.
  5. When do I have to start ordering hydrocodone-containing products using DEA Form 222 or CSOS?  October 6, 2014.
  6. I have stock bottles of hydrocodone-containing products that are labeled “C III.”  Do I need to relabel them?  No.  Manufacturers must label all hydrocodone-containing products “C II” by October 6, 2014.  Neither pharmacists nor manufacturers are required to relabel stock bottles distributed prior to October 6, 2014.
  7. Does this affect North Carolina’s identification requirement for dispensing controlled substances?  No.  North Carolina’s controlled substance identification statute already requires that an identification be obtained prior to dispensing any Schedule II controlled substance, and for certain Schedule III controlled substances.  Hydrocodone-containing products were among the Schedule III controlled substances for which an identification had to be obtained.  More information about the controlled substance identification statute may be found here:
  8. Will hydrocodone-containing product prescriptions have a six-month expiration date under North Carolina law?  Yes.  More information concerning that statute, which went into effect October 1, 2013, may be found below.

Q: What is the proper way to document receipt of schedule II controlled substance orders when using DEA's Controlled Substance Ordering System (CSOS)?

A: During recent pharmacy inspections, Board investigators have noted that multiple pharmacies have not properly documented receipt of schedule II controlled substance orders when using the CSOS. 

Board investigators have found the CSOS orders were properly placed in accordance with 21 Code of Federal Regulations (CFR) 1305.21 and 1305.22(a). However, upon receipt of the controlled substances, a copy of the E-222 form was printed and receipt of the order manually noted on paper. This paper receipt process violates 21 CFR 1305.22(g), although Board investigators have found these violations to be unintentional and are treating them as an educational issue, not a disciplinary one.  Under that federal rule, when a purchaser receives a shipment, the purchaser must create a record of the quantity of each item received and the date received, and that record must be electronically linked to the original order and archived.

Board staff strongly recommend that pharmacies ordering Schedule II controlled substances using CSOS, but unsure how to electronically link the receipt with the original order, contact the schedule II controlled substance supplier for assistance.


Q: May a prescribing practitioner prescribe other medications on a prescription that already includes a Schedule II medication?

A: Yes, a practitioner may prescribe other medications on the same prescription blank along with Schedule II medications.


Q: Can I fill Schedule II prescriptions bearing a "do not fill until" date?

A: Yes, within limits established by DEA:

Effective December 19, 2007 prescribers will be authorized to write multiple prescriptions on the same day to be filled sequentially for schedule II controlled substances. The Drug Enforcement Agency (DEA) issued the final rule on Monday, November 19, which reflects APhA's recommendation to remove language that could have been interpreted to add an additional duty on health providers (including pharmacists) for schedule II prescriptions. However, the DEA chose not to defer to prescribers on the most appropriate time limitation, instead retaining the 90-day the prescription order limit in the original proposed rule. The new regulation does not affect State laws and regulations, which may be more restrictive. Specifically, the new rule amends Title 21 of the Code of Federal Regulations, Part 1306 as follows:

§ 1306.12 Refilling prescriptions; issuance of multiple prescriptions.
(a) The refilling of a prescription for a controlled substance listed in Schedule II is prohibited.
(b)(1) An individual practitioner may issue multiple prescriptions authorizing the patient to receive a total of up to a 90-day supply of a Schedule II controlled substance provided the following conditions are met:
(i) Each separate prescription is issued for a legitimate medical purpose by an individual practitioner acting in the usual course of professional practice;
(ii) The individual practitioner provides written instructions on each prescription (other than the first prescription, if the prescribing practitioner intends for that prescription to be filled immediately) I indicating the earliest date on which a pharmacy may fill each prescription;
(iii) The individual practitioner concludes that providing the patient with multiple prescriptions in this manner does not create an undue risk of diversion or abuse;
(iv) The issuance of multiple prescriptions as described in this section is permissible under the applicable state laws; and
(v) The individual practitioner complies fully with all other applicable requirements under the Act and these regulations as well as any additional requirements under state law.
(2) Nothing in this paragraph (b) shall be construed as mandating or encouraging individual practitioners to issue multiple prescriptions or to see their patients only once every 90 days when prescribing Schedule II controlled substances. Rather, individual practitioners must determine on their own, based on sound medical judgment, and in accordance with established medical standards, whether it is appropriate to issue multiple prescriptions and how often to see their patients when doing so.

3. Section 1306.14 is amended by adding a new paragraph (e) to read as follows:

§ 1306.14 Labeling of substances and filling of prescriptions.
(e) Where a prescription that has been prepared in accordance with section 1306.12(b) contains instructions from the prescribing practitioner indicating that the prescription shall not be filled until a certain date, no pharmacist may fill the prescription before that date.



Q: What changes can be made to Schedule II Prescriptions?

A: After consulting with the prescribing practitioner (you must speak directly to the practitioner, not his/her agent), the pharmacist may modify or add the following:

  • date of issue – may be added but not changed;
  • patient’s address;
  • drug strength;
  • drug dosage form;
  • drug quantity – may be modified in conjunction with change in strength only, not to exceed the original total dosage prescribed; and
  • directions for use.

A pharmacist may never change the name of the drug (except to generic when appropriate), name of the patient, or the signature of the practitioner.


Q: Do prescription orders or prescription documents have an expiration date?

A: There is no specific provision in statute or rule that says a prescription document or order has an expiration date. Federal regulations provide that prescriptions for drugs in Schedules III and IV shall not be filled or refilled more than 6 months after the date of issue. Effective October 1, 2013, North Carolina law provides that “No Schedule II substance shall be dispensed pursuant to a written prescription more than six months after the date it was prescribed.”

Board rule provides that a pharmacist can refuse to fill or refill a prescription if they believe it is harmful to the patient, not in the patient’s best interest or there is a question as to its validity.


Q: Can I give an emergency refill on a weekend if the patient needs it when there are no refills left on the script?

A: Board Rule .1809 allows a pharmacist to give up to a 30 day supply of any drug except a Schedule II controlled substance under these circumstances. You do need to contact the prescriber or the prescriber's office within 72 hours to notify them of what you have done.

You can find the rule here:


Q: What is the procedure in North Carolina for physicians when ordering Schedule II, III, and IV controlled substances for office use?

A: The physician needs to complete a Schedule II Order form (DEA 222; see for a drug in Schedule II and send it to the supplier which can be a pharmacy. The supplier keeps one copy and send the other copy to DEA. Note the instructions in the margin of the form.

Orders for drugs in Schedule III or IV can occur on an invoice and the supplier (pharmacy) keeps these invoices with other CS records noting that these are outgoing items.

These transactions should not occur pursuant to a prescription because prescriptions need to be patient specific.


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