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Pharmacist FAQs

Frequently Asked Questions for Pharmacists on Schedule II Controlled Substances

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.

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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.

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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 (http://a257.g.akamaitech.net/7/257/2422/01jan20071800/edocket.access.gpo.gov/2007/pdf/E7-22558.pdf), 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.

APhA's statement to the DEA on the proposed regulation can be accessed here.

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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.

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

A: 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. State law (that went into effect on October 1, 2013) provides that "No Schedule II substance shall be dispensed pursuant to a written prescription more than six months after the date it was prescribed." The new six-month limitation applies to all prescriptions issued on or after October 1, 2013.

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.

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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: http://www.ncbop.org/ch46-18.htm.

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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 http://www.deadiversion.usdoj.gov/drugreg/change_requests/order_form.htm) 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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