General FAQs / Minnesota Board of Pharmacy

For the dispensing of buprenorphine for opioid dependence treatment from non-Opioid Treatment Program facilities, what are the prescription requirements, and how should the prescriber’s information be reported to the MN PMP?

Buprenorphine is a schedule III controlled substance. According to 21 CFR 1306.05 (a), controlled substance prescriptions must bear the name, address, and registration number of the prescriber. When buprenorphine is prescribed for the treatment of opioid dependence, the DEA requires both the prescriber’s regular DEA registration number as well as the DATA 2000 waiver number to be included on the prescription. See the link: https://www.samhsa.gov/medication-assisted-treatment/buprenorphine-waiver-management/qualify-for-physician-waiver as well as 21 CFR 1306.05 (a) and (b) for more information.

For special circumstances where buprenorphine can be provided without a waiver:
https://www.samhsa.gov/programs-campaigns/medication-assisted-treatment/legislation-regulations-guidelines/special

To verify a prescriber’s DATA waiver:
https://www.samhsa.gov/bupe/lookup-form

For the purposes of reporting to the MN PMP, only the prescriber DEA field (PRE02) is required. The DATA 2000 waiver number MUST NOT be reported in the prescriber DEA field (PRE02) when reporting to the MN PMP. Only the prescriber’s regular DEA registration number should be reported. If the pharmacy needs to include the DATA 2000 waiver number for the purposes of processing the prescription claim to a third party payer, the whereabouts of entering this number should be determined with the pharmacy’s software vendor so long as it does not get carried forward in the prescriber’s DEA field (PRE02) to the MN PMP.
I just received a prescription for Methadone. Can I dispense it?

Methadone can be dispensed by a pharmacist pursuant to a prescription issued for analgesic purposes. The following article was taken from the May, 1996 State Board News and addresses this issue in detail:

Methadone and the Community Pharmacy.

In December 1972, the commissioner of Food and Drugs prohibited the shipment to, or receipt or dispensing of, methadone by community pharmacies for analgesic purposes (37 Fed. Reg. 26,790). The regulations adopted by the federal Food and Drug Administration (FDA) established the conditions for use of the drug by methadone treatment programs to detoxify and maintain narcotic addicts and byhospitals for analgesic purposes on a temporary basis.Both the drug treatment programs and the hospital pharmacies had to be approved by FDA to purchase, receive, and use methadone.

On July 9, 1976, these restrictions were lifted by FDA (41 Fed. Reg. 28,261). Accordingly, all licensed pharmacies can purchase, receive, and dispense methadone for analgesic purposes after this date. However, questions received by the Board office indicate that many practicing pharmacists are not aware of the fact that methadone has been available for dispensing for analgesic purposes by community pharmacists since 1976.

Federal regulations do not permit the prescribing of methadone for purposes of detoxifying or maintaining a narcotic addict. Prescriptions issued for this purpose are illegal and do not authorize pharmacists to dispense methadone for these purposes. The federal regulations require that methadone may only be administered for these purposes by drug treatment programs approved by the FDA (21CFR 1306.07).

21 CFR 1306.04(Purpose of issue of prescription) provides that a prescription may not be issued for the purpose of dispensing of narcotic drugs in any schedule for detoxification treatment or maintenance treatment. These terms are defined as follows in Section 102 of the federal Controlled Substance Act (21 U.S.C. 802).

21 USC 802 Definitions.

As used in this subchapter:

(29) The term maintenance treatment means the dispensing, for a period in excess of twenty-one days, of a narcotic drug in the treatment of an individual for dependence upon heroin or other morphine-like drugs.

(30) The term detoxification treatment means the dispensing, for a period not in excess of one hundred and eighty days, of a narcotic drug in decreasing doses to an individual in order to alleviate adverse physiological or psychological effects incident to withdrawal from the continuous or sustained use of a narcotic drug and as a method of bringing the individual to a narcotic drug-free state within such period.

Pharmacists practicing in community pharmacies have received prescriptions in which it was obvious that the prescriber was attempting to provide detoxification treatment for a patient who has become dependent on morphine-like drugs. These prescriptions are not valid and narcotics should not be dispensed under these circumstances. The pharmacist needs to contact the physician to inquire about their intent and to inform them about federal regulations governing the use of narcotics to detoxify the patient.
Can I mail prescription medications containing narcotics or other controlled substances?

Yes, according to theUnited States Postal Service regulations.If the prescription medications have been dispensed in accordance with federal and state regulations, including proper labeling, and placed in a plain outer container or securely overwrapped in plain paper which is free of marking that would indicate the nature of the contents.
Can I fill a prescription for a Schedule II drug written by a mid-level practitioner?

Yes, provided that the mid-level practitioner has a valid agreement with a licensed practitioner that delegates the prescribing of that drug to the mid-level practitioner and the mid-level practitioner has a current federal drug enforcement registration number. Note, the federal drug enforcement registration number must be that of the mid-level practitioner, not that of the delegating licensed practitioner.
Where can I find a chart showing the daily limits for retail pseudoephedrine sales?
Are electronic prescriptions for controlled substances allowed in Minnesota?

In 2012 the Governor signed into law legislation that allows controlled substances to be electronically prescribed for Schedule II, III, IV or V prescriptions in accordance with applicablefederal rules. MN Board of Pharmacy Statute 152.11 was revised to address electronic controlled substance prescriptions.

152.11 PRESCRIPTIONS.

Subdivision 1.General prescription requirements for controlled substances.

(a) A written prescription or an oral prescription reduced to writing, when issued for a controlled substance in Schedule II, III, IV, or V, is void unless (1) it is written in ink and contains the name and address of the person for whose use it is intended; (2) it states the amount of the controlled substance to be compounded or dispensed, with directions for its use; (3) if a written prescription, it contains the handwritten signature, address, and federal registry number of the prescriber and a designation of the branch of the healing art pursued by the prescriber; and if an oral prescription, the name and address of the prescriber and a designation of the prescriber's branch of the healing art; and (4) it shows the date when signed by the prescriber, or the date of acceptance in the pharmacy if an oral prescription.

(b) An electronic prescription for a controlled substance in Schedule II, III, IV, or V is void unless it complies with the standards established pursuant to section 62J.497 and with those portions of Code of Federal Regulations, title 21, parts 1300, 1304, 1306, and 1311, that pertain to electronic prescriptions.

(c) A prescription for a controlled substance in Schedule II, III, IV, or V that is transmitted by facsimile, either computer to facsimile machine or facsimile machine to facsimile machine, is void unless it complies with the applicable requirements of Code of Federal Regulations, title 21, part 1306.

(d) Every licensed pharmacy that dispenses a controlled substance prescription shall retain the original prescription in a file for a period of not less than two years, open to inspection by any officer of the state, county, or municipal government whose duty it is to aid and assist with the enforcement of this chapter. An original electronic or facsimile prescription may be stored in an electronic database, provided that the database provides a means by which original prescriptions can be retrieved, as transmitted to the pharmacy, for a period of not less than two years.

(e) Every licensed pharmacy shall distinctly label the container in which a controlled substance is dispensed with the directions contained in the prescription for the use of that controlled substance.

Subd. 1a.Prescription requirements for Schedule II controlled substances.

No person may dispense a controlled substance included in Schedule II of section 152.02 without a prescription issued by a doctor of medicine, a doctor of osteopathy licensed to practice medicine, a doctor of dental surgery, a doctor of dental medicine, a doctor of podiatry, or a doctor of veterinary medicine, lawfully licensed to prescribe in this state or by a practitioner licensed to prescribe controlled substances by the state in which the prescription is issued, and having a current federal Drug Enforcement Administration registration number. The prescription must either be printed or written in ink and contain the handwritten signature of the prescriber or be transmitted electronically or by facsimile as permitted under subdivision 1. Provided that in emergency situations, as authorized by federal law, such drug may be dispensed upon oral prescription reduced promptly to writing and filed by the pharmacist. Such prescriptions shall be retained in conformity with section 152.101. No prescription for a Schedule II substance may be refilled.

Subd. 2. Prescription requirements for Schedule III or IV controlled substances.

No person may dispense a controlled substance included in Schedule III or IV of section 152.02 without a prescription issued, as permitted under subdivision 1, by a doctor of medicine, a doctor of osteopathy licensed to practice medicine, a doctor of dental surgery, a doctor of dental medicine, a doctor of podiatry, a doctor of optometry limited to Schedule IV, or a doctor of veterinary medicine, lawfully licensed to prescribe in this state or from a practitioner licensed to prescribe controlled substances by the state in which the prescription is issued, and having a current federal drug enforcement administration registration number. Such prescription may not be dispensed or refilled except with the documented consent of the prescriber, and in no event more than six months after the date on which such prescription was issued and no such prescription may be refilled more than five times.

Link to Code of Federal Regulations, Title 21, parts 1300 1321 is: http://www.gpo.gov/fdsys/browse/collectionCfr.action?collectionCode=CFRandsearchPath=Title+21%2FChapter+IIandoldPath=Title+21andisCollapsed=trueandselectedYearFrom=2014andycord=801
What information can be changed (or added) to a Schedule II prescription and Schedule III-V prescriptions by a pharmacist? 10/21/2013

For CII prescriptions the DEA is currently deferring to the states on this issue.The Minnesota Board of Pharmacy has adopted this position:

The pharmacist may add or change the patients address upon verification. The pharmacist may add or change the dosage form, drug strength, drug quantity, directions for use, or issue date only after consultation with and with the agreement of the prescribing practitioner. Such consultations and corresponding changes should be noted by the pharmacist on the prescription. The pharmacist may add the DEA number of the prescriber upon determining that the prescription is legally valid. The pharmacist is never permitted to make changes to the patients name, controlled substance prescribed (except for generic substitution permitted by state law) or the prescribers signature.

Pharmacists may also want to review thisletterfrom the DEA to the National Association of Boards of Pharmacy. The letter provides additional information concerning the issue and emphasizes that pharmacists should use their professional judgement and knowledge of state and federal laws and policies to decide whether it is appropriate to make changes to a CII prescription.

For CIII - CV prescriptions the pharmacist may add or change the patients address upon verification. The pharmacist may add or change the dosage form, drug strength, drug quantity, directions for use, or issue date only after consultation with and with the agreement of the prescribing practitioner. Such consultations and corresponding changes should be noted by the pharmacist on the prescription. The pharmacist may add the DEA number of the prescriber upon determining that the prescription is legally valid. The pharmacist is never permitted to make changes to the patients name, controlled substance prescribed (except for generic substitution permitted by state law) or the prescribers signature.
Is there a time limit between the date a prescription for a Schedule II drug is issued and the date when it may be filled?

There is no time limit under federal law, however under Minnesota Rules, a one year limit from the date of issue exists for all prescriptions. DEA's recent rule change allowing for the issuance of multiple prescriptions authorizing the patient to receive a total of up to a 90-day supply of a Schedule II controlled substance have not added a limit of 90 days from the date of issue that a pharmacy may fill these prescriptions. It has limited how soon a pharmacy may fill a prescription for a Schedule II controlled substance to not earlier than the date specified on the prescription by the prescriber.
Is there a six month/five refill limit on Schedule V drugs?

No. While federal rules provide that prescriptions for drugs in Schedules III and IV cannot be filled or refilled longer than six months after the date they were issued, prescriptions for Schedule V drugs can be refilled, as authorized, up to one year from the date of issue state limit. Keep in mind that federal Schedule V codeine containing cough syrups are Schedule III in Minnesota and underMinnesota Statute 152.11are subject to the six month/five refill limitation.
Can I partially fill a prescription for a Schedule II drug?

Yes, a prescription for a Schedule II drug can now be partially filled.

On July 22, 2016, in an effort to address the prescription opioid abuse crisis the Comprehensive Addiction and Recovery Act of 2016 (Act), was signed into law. The Act amended the Controlled Substances Act to allow a pharmacist to partially fill a prescription for a Schedule II controlled substance (CS). Previously, according to 21 Code of Federal Regulations §1306.13(a), partially filling a Schedule II CS was only permissible if the pharmacist was unable to supply the full quantity as issued on the prescription and required that the remaining portion be filled within 72 hours.

The Act specifically amends 21 United States Code §829 by adding subsection (f), which allows for the partial filling of a Schedule II CS prescriptions if the following conditions are met:

•          it is not prohibited by state law (Minnesota law does not prohibit partial filling of Schedule II drugs);

•          the prescription is written and filled in accordance with federal and state law;

•          the partial fill is requested by the patient or the practitioner who wrote the prescription; and

•          the total quantity dispensed in all partial fillings does not exceed the total quantity prescribed.

The Act also provides that the remaining portion of a partially filled Schedule II CS prescription may be filled not later than 30 days after the date on which the prescription was written. However, if the partial filling of a Schedule II CS is the result of an emergency situation oral prescription, the pre-existing partial fill time frame of 72 hours after the prescription was issued remains.
Can a pharmacy transfer a controlled substance prescription that has been profiled but not actually dispensed?

On July 20, 2017, the Board received the following information from NABP regarding Drug Enforcement Administration (DEA) regulations and the transfer of unfilled (i.e. profiled) prescriptions for controlled substances. The DEA regulations allow a registered pharmacy to transfer prescriptions to another registered pharmacy – but only after the pharmacy that originally received the prescription has actually filled (emphasis added) the prescription at least once. (The specific regulation is 21 CFR 1306.25). The transfer allows the receiving pharmacy to dispense any remaining valid refills on the prescription. However, nothing in the DEA regulations authorizes the transfer of an unfilled prescription. In the correspondence below, the DEA mentions that an unfilled electronic controlled substance prescription, which is defined in 21 CFR 1300.03, can be forwarded by one registered pharmacy to another. But forwarding a prescription is not the same thing as transferring a prescription. When it uses the term “forwarding,” the DEA means sending the electronic prescription to the other pharmacy through an e-prescribing system. This means that unless your pharmacy has the capability to electronically forward an electronic prescription to another pharmacy, you cannot transfer an electronic controlled substance prescription until you have filled the prescription at least once.
In summary – electronic, paper, faxed or verbal controlled substance prescriptions cannot be transferred unless they have been filled at least once. Electronically prescribed controlled substance prescriptions that have not been filled can be forwarded – but only electronically. Since this is the official DEA interpretation of federal rules, the Board expects pharmacies to act accordingly.
Communication from the DEA received from NABP:
“The Controlled Substances Act and its implementing regulations outline what can take place regarding prescriptions for controlled substances. In Title 21, Code of Federal Regulations, Section 1306.25 the DEA made a specific exception so that a DEA registered pharmacy can, once it has filled an original prescription for a controlled substance in Schedules III-V, transfer the original prescription information to another DEA registered pharmacy for the purpose of allowing that second pharmacy to then dispense any remaining valid refills still permitted by law and the prescriber’s authorization. With one exception, such an allowance currently does not exist for the forwarding of an unfilled prescription from one DEA registered retail pharmacy so that it may be filled at another DEA registered retail pharmacy.
Prescriptions can take the form of paper (including fax), call-in, or electronic prescription for controlled substances (EPCS). The DEA has addressed the forwarding of an EPCS prescription. The DEA published information in the preamble of the notice of proposed rulemaking (NPRM) on EPCS, 73 FR 36722, and the preamble of the interim final rule (IFR) on EPCS, 75 FR 16235. Note, because this was in the preamble and not in the EPCS regulations, it represents the DEA’s policy. As posted in the preambles of the NPRM and the IFR, an unfilled original EPCS prescription can be forwarded from one DEA registered retail pharmacy to another DEA registered retail pharmacy, and this includes Schedule II controlled substances.
At the start of 2017, the DEA received inquiries from some pharmacists regarding this issue. The DEA was advised that these pharmacists had received notice from their management that they could not forward original unfilled prescriptions for controlled substances as there was no exception in Federal regulation that expressly allowed this activity. The pharmacists were provided with the above information. Although the DEA received several inquiries regarding this issue earlier in the year, these have now ceased.
I hope this helps you and the members of your association.
Loren T. Miller Associate Section Chief
Liaison and Policy Section Diversion Control Division
Drug Enforcement Administration”

Does the Board have information about pharmacist provided immunizations?

I allowed my license to practice pharmacy in Minnesota to lapse and now I want it reinstated. What do I need to do?

In the state of Minnesota a pharmacist is eligible to reinstate their license within two years from the expiration date of the last time they renewed their license by simply paying back renewal fees, late fees, and doing their back continuing education.

If they are reinstating after the two year period they need to do the following.
Does your Board have license verification on the internet?
Does your Board of Pharmacy license or register medical device or medical supply manufacturers, wholesale distributors, supplies or retailers?

The Board does not license or register companies that exclusively manufacture, distribute, supply or sell medical devices or supplies. If a company that handles medical devices or supplies also manufactures or distributes drugs, it must be licensed as a drug manufacturer or drug wholesaler. Exception if the drug is coated on or embedded in the device (e.g. drug-coated stents) and the resultant product is approved by the FDA as a device, the company does not have to be licensed as a manufacturer or wholesale distributor.
What is a “virtual manufacturer” and what are their licensing requirements?

A virtual manufacturer is an entity that holds the approved New Drug Application (NDA) or the Abbreviated New Drug Application (ANDA) for a drug and contracts with a contract manufacturing organization (CMO) for the physical manufacture of the drug. A virtual manufacturer also usually contracts with third party logistic providers (3PLs) for distribution of the drug.

Virtual manufacturers of legend and/or OTC drugs are required to be licensed as a manufacturer (see Minn Stats. § 151.252). When applying, a virtual manufacturer should explain its business model, indicating that it is a virtual manufacturer. A virtual manufacturer should include the FDA registration number/labeler code, a list of Minnesota licensed CMO(s), Minnesota licensed distributers and 3PLs. A wholesale license may also be required if the virtual manufacturer holds title/ownership of the product when it is sold to an entity located in Minnesota. All applications and requirements are located on the Minnesota Board of Pharmacy website: www.pharmacy.mn.gov

What do I need to do for my pharmacy to begin collecting discarded pharmaceuticals?
I have received e-mail (spam) and/or a fax from a company claiming to be a pharmacy licensed by the Minnesota Board of Pharmacy. (Or, I have visited a website that displays a license supposedly issued by the Board). Has the Board issued a license to this company or website? If not, what can the Board do to stop the company from sending me spam or faxes? Can the Board make them remove charges from my credit card? I have received a telephone call from someone claiming to work for a licensed pharmacy who encourages me to order from them or asks me for credit card information. Can the Board stop them from calling me?
Minnesota Statutes § 151.461 prohibits gifts to practitioners by drug wholesales and manufacturers. Can you provide additional information about this law?

Where can I find information about the Board's continuing education requirement for pharmacy technicians?

Can prescriptions be transferred more than once in Minnesota?

Prescriptions for non-controlled drugs can be transferred from one pharmacy to another indefinitely providing that refill authorizations do exist and the transfers are properly recorded. However, there are restrictions on controlled substances. Minnesota Rule 6800.3120 Subp. 2. states: A pharmacy may transfer prescription information for the purpose of refilling a prescription if the information is communicated directly by one licensed pharmacist to another. Schedule II prescriptions may not be transferred. Schedules III-V prescriptions may only be transferred in accordance with the limitations placed on such transfers by the Drug Enforcement Administration (DEA). Federal regulation21 CFR1306.25(a) permits multiple transfers of controlled substances, providing authorization exists,only for those pharmacies that share a real time on-line electronic database. Other pharmacies are limited to only one transfer under federal rules.
Can I fill or refill a prescription from an out-of-state prescriber?

Minnesota pharmacies may legally fill or refill, providing refill authorizations exist, prescriptions from prescribers practicing in any state. If the prescription is for a controlled substance in Schedule II, III or IV, the practitioner must be licensed to prescribe controlled substances by the state in which the prescription is issued and have a current federal Drug Enforcement Administration registration number. Schedule II prescriptions, or course, cannot be refilled.
How long must I keep prescription records?

Minnesota law requires prescription records to be kept for a minimum of two years. Federal DEA regulations also require that controlled substance records be kept for a minimum of two years. The Food and Drug Administration (FDA) maintains that in its enforcement of the Federal Food, Drug, and Cosmetic Act, it may request records of drug distribution dating back five years. As of January 1, 2005 the Medicare Modernization Act of 2003 requires prescription records to be kept for ten years. Pharmacists should also seek the advice of their attorney for an answer to this question.
Can I accept a new prescription via a facsimile machine?

Minnesota Rules do allow a pharmacy to accept a prescription transmitted by facsimile from the prescriber to the pharmacy, provided the facsimile document is readily readable for at least five years. Facsimile orders for controlled substance in Schedules II, III, and IV can only be accepted if in compliance with federal DEA rules.

Federal regulations do allow for the transmission of a prescription to a pharmacy by a practitioner, or the practitioneer's agent, for controlled substances in Schedule III, IV and V.(21CFR1306.21,a)The following federal regulations apply to prescriptions for Schedule II controlled substances.(21CFR1306.11)
Can a Pharmacist dispense up to a 90-day supply
Can I make generic substitutions for epinephrine auto-injectors without contacting the prescriber?

Yes, at least in certain circumstances, with the following considerations in mind.

In regards to when a pharmacist can make a generic substitution without consulting the prescriber, Minn. Stats. Section 151.21 uses the phrases (emphasis added):

“a less expensive generically equivalent drug that, in the pharmacist's professional judgment, is safely interchangeable with the prescribed drug,” and

“A pharmacist may not substitute a generically equivalent drug product unless, in the pharmacist's professional judgment, the substituted drug is therapeutically equivalent and interchangeable to the prescribed drug.”

Consequently, a pharmacist is not required to use the Orange Book when making generic substitutions. However, pharmacists have to have some sort of basis for their “professional judgment.” If the Orange Book is not consulted, or if the Orange Book does not list the generic as being therapeutically equivalent to the brand name product, the pharmacist should have some other, legitimate and documented basis for concluding that a drug is generically and therapeutically equivalent to the drug prescribed – and that it is safely interchangeable. If pharmacists do not have a documented basis for substitution, they should contact the prescriber for approval of the substitution and document this on the prescription.

In January 2017 Mylan began supplying an authorized generic for EpiPen. According to a document that Mylan sent to the Board, these two products are generically and therapeutically equivalent. In fact, they are identical products – except for the labeling. In this case a pharmacist may substitute the authorized Mylan generic for the EpiPen without consulting the prescriber

In addition, an epinephrine auto-injector produced by Impax/Lineage Therapeutics is an authorized generic for Adrenaclick. In its fact sheet for the generic product, found at: www.epinephrineautoinject.com/pdf/Epi-Fact-Sheet.pdf, Impax states that the generic product is generically equivalent to Adrenaclick. Consequently, a pharmacist may substitute the Impax/Lineage authorized generic for Adrenaclick.

According to the Orange Book, EpiPen and Adrenaclick have a BX rating, meaning that insufficient evidence exists to show that the two products are therapeutically equivalent. Consequently, pharmacists would need permission from the prescriber to substitute Adrenaclick (or its authorized generic) if EpiPen is prescribed (and vice versa) – unless pharmacists have another credible and documented reason for determining that EpiPen and Adrenaclick are therapeutically equivalent and safely interchangeable.

Since the instructions for use are slightly different for the various epinephrine auto-injectors, it is important for pharmacists to counsel patients on proper use, especially when making a generic substitution.

For further information on “authorized generics” please see the Orange Book Preface at the link: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/ucm079068.htm

What information can the Board provide regarding the use of medical cannabis?

The Minnesota Board of Pharmacy has been fielding many calls about the use of medical cannabis in the hospital setting, however, the Board is not involved in the regulation or distribution of medical cannabis. For more information please visit the Minnesota Medical Cannabis website or contact the Office of Medical Cannabis, which is part of the Department of Health.

http://www.health.state.mn.us/topics/cannabis/

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