DEA VERBIAGE Regarding Ekit/ADS:
As set forth in 21 CFR § 1301.27, a retail pharmacy that installs and operates an ADS at an LTCF must maintain a separate registration at that location.
All emergency kits:
All E-KITs whether or not they are electronic - remain subject to the DEA 1980 policy statement (and thus need not be separately registered), provided they satisfy the criteria of the 1980 policy statement at all times. Among other things, it is crucial to bear in mind that an emergency kit is only an emergency kit if it is used exclusively for emergencies. It also bears emphasis that, in accordance with the CSA and DEA regulations, a controlled substance may only be dispensed for emergency purposes (or otherwise) pursuant to a valid prescription. Thus, controlled substances may not be dispensed from the kit for emergencies prior to receipt by the pharmacist of a valid prescription in accordance with the requirements in 21 CFR §§ 1306.11 and 1306.21. As these sections of the regulations indicate, such prescription may, depending on the circumstances, be issued in writing (paper or electronic in accordance with part 1311), orally, or by fax. In addition, to be valid, a prescription for a controlled substance must be issued for a legitimate medical purpose by a practitioner acting in the usual course of his professional practice, and the pharmacist bears a corresponding responsibility therefor. 21 CFR § 1306.04(a).
If, at any time, a kit is used to administer or dispense controlled substances for a purpose other than an emergency, the kit thereafter ceases to be an emergency kit and, as a result, the separate registration requirement applies.
The short answer is - no. The Board became aware of a pharmacy that was operating solely as a “call center” as part of a central service pharmacy arrangement it had with other commonly owned pharmacies. Among other things, calls for prescription transfers were routed to that pharmacy from the other pharmacies involved. The central service pharmacy logged into a common, electronic record system and made the transfers on behalf of the other pharmacies. Some of the transfers were for controlled substances.
The Board contacted the United States Drug Enforcement Administration to determine if this practice is legal under federal statutes and regulations. The DEA responded by telling the Board that it is not legal. A portion of the DEA response is as follows:
“Because the regulations at 21 C.F.R. § 1306.25 require that a controlled substance prescription transfer must be ‘communicated directly’ between the pharmacists responsible for filling the prescriptions, a ‘central service pharmacy,’ under the circumstances you have described, cannot transfer paper prescriptions or electronic prescriptions for controlled substances in conformity with the applicable regulations.”
Consequently, a controlled substance prescription should only be transferred by the original pharmacy that filled the prescription – and only to the pharmacy that will actually dispense subsequent refills.
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 by hospitals 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.
Yes - provided that, when necessary, 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.Please note that in Minnesota, Advanced Practice Registered Nurses do not need to have a written prescribing agreement in place – they can prescribe on their own, without delegation. When delegation is required, the federal drug enforcement administration registration number must be that of the mid-level practitioner, not that of the delegating licensed practitioner.
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 this letter from 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.
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”
If the activities at the distribution warehouse only involve distribution of that manufacturers own products – and not things like repackaging and relabeling – the facility doesn’t need to be licensed (not as a manufacturer and not as a wholesaler).
The definition of a 3PL as defined in Minnesota Statute 151.441, was taken directly from federal law and it uses the word "product" not the word "drug." Consequently, a 3PL that handles ONLY OTC products, does not need to be licensed. Note that the definition of wholesaler distribution uses the word “drug” – so wholesalers of OTC drugs do have to be licensed.
If all dispensing and certification processes occur outside of the State of Minnesota in your Minnesota licensed non-resident pharmacy, then no it is not also required to be a Minnesota licensed pharmacist so long as you meet your own resident state requirements and laws for dispensing.
If you are engaged in dispensing prescriptions as part of a central service pharmacy arrangement, and any part of the dispensing and certification processes occurs both in your pharmacy and at another pharmacy located in the State of Minnesota, then the answer is yes. These processes may only be completed by Minnesota licensed pharmacists. Any pharmacist participating in these arrangements must also be a Minnesota licensed pharmacist. This process additionally requires approval of central service policies and other possible variances prior to implementation.
For the purpose of this question, processes involved in dispensing include but are not limited to the items listed in Minnesota Rule 6800.3100 Compounding and Dispensing. Review Minnesota Rule 6800.4075 for more information regarding centralized prescription processing and filling requirements.
If you are a pharmacist who is not dispensing but you are providing clinical services to a patient in the State of Minnesota then this would be considered practicing pharmacy, and you would be required to have a Minnesota pharmacist license. See MS 151.01 Subd. 27.
That depends. Just because you are the PIC does not have any bearing on whether you need to be a Minnesota licensed pharmacist.
If all dispensing and certification processes occur outside of the State of Minnesota in your Minnesota licensed, non-resident pharmacy then no it is not also required to be a Minnesota licensed pharmacist so long as you meet your own resident state requirements and laws in dispensing.
If you are engaged in dispensing prescriptions as part of a central service pharmacy arrangement, and any part of the dispensing and certification processes occurs both in your pharmacy and at another pharmacy located in the State of Minnesota, then the answer is yes. These processes may only be completed by Minnesota licensed pharmacists. Any pharmacist participating in these arrangements must also be a Minnesota licensed pharmacist. This process additionally requires approval of central service policies and other possible variances prior to implementation.
For the purpose of this question, processes involved in dispensing include but are not limited to the items listed in Minnesota Rule 6800.3100 Compounding and Dispensing. Review Minnesota Rule 6800.4075 for more information regarding centralized prescription processing and filling requirements.
If you are a pharmacist who is not dispensing but you are providing clinical services to a patient in the State of Minnesota then this would be considered practicing pharmacy, and you would be required to have a Minnesota pharmacist license.
So long as you are not engaged in any part of the dispensing process, or a central prescription processing arrangement then the practice of pharmacy is not required to be completed from within a licensed pharmacy space. If you are reviewing or approving orders, receiving orders from practitioners, or are a part of the dispensing process in any way then yes, these practices must occur only within a licensed pharmacy. See Minnesota Statute 151.15.
For the purpose of this question, processes involved in dispensing include but are not limited to the items listed in Minnesota Rule 6800.3100 Compounding and Dispensing. Review Minnesota Rule 6800.4075 for more information regarding centralized prescription processing and filling requirements.
Currently, Minnesota does not require a separate registration, license, or credential specifically for controlled substances. So long as your facility has and maintains the appropriate registration with the DEA and your home state, there is currently no additional requirement. Continue to monitor our website and this FAQ regarding any new state legislation notices regarding possible changes on this topic.
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.
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.
Yes. Contact Minnesota’s Bookstore by phone at 651-201-3206 or fax at 651-215-5733. Please visit their website for more details. Minnesota's Bookstore.
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.
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.
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 practitioner'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).
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
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.
Per Minnesota Rule 6800.3120 subp. 2, a fax is not deemed to be direct. It can certainly be used to facilitate the transfer, but the actual transfer needs to be conducted from one pharmacist/intern to another pharmacist/intern verbally, so they can verify the information and legitimacy of the prescription and confirm the fax.
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.
