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.
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.
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 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.
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.
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.(21 CFR 1306.21,a). The following federal regulations apply to prescriptions for Schedule II controlled substances (21 CFR 1306.11).
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 contact the Office of Medical Cannabis at https://mn.gov/ocm/dmc/
