General FAQs

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.

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.

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.

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”

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

Answer.

Yes, click here for frequently asked questions related to this issue.

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