- Is a pharmacist working under a collaborative drug therapy agreement (CDTA) allowed to prescribe controlled substances?
A pharmacist working under a collaborative drug therapy agreement (CDTA) may prescribe controlled substance (CS) prescriptions under the following conditions:
- The scope of the CDTA must permit this activity; and
- The pharmacist must have a Drug Enforcement Administration (DEA) registration (unless exempted from obtaining a DEA registration, for example see the FAQ on use of the hospital DEA with a suffix).
Pharmacists acting with prescriptive authority to prescribe CS must have their own unique DEA registration issued by DEA. (From PQAC Newsletter No. 1283 Practitioner DEA Registrations, April 2018 (PDF) Note: DEA regulations are within the authority of the DEA, so final determination on the need for DEA registration lies with the DEA and not the Pharmacy Commission.
For additional information on CDTAs see the Commission's CDTA – Interim Guidance on Collaborative Drug Therapy (PDF).
- Is a hospital pharmacist with prescriptive authority under a collaborative drug therapy agreement (CDTA) or other licensed prescribers (such as medical residents) allowed to use their hospital's DEA number on a controlled substances prescription?
Yes, if in compliance with applicable DEA regulations.
The DEA allows any prescriber (as determined by state law) to use the hospital's DEA registration as long as two conditions are met: (i) the prescription or order is entered for drugs to be dispensed and/or administered within the hospital, and (ii) the hospital assigns a specific suffix to the end of the hospital's DEA registration that is unique to the prescriber. The specific suffix will be maintained internally by the hospital.
This might be done with medical residents or other licensed prescribers working within an institutional setting.
Hospital DEA: AB1234567 – 012 (emphasis indicates internal code unique identifier added as a suffix 012)
You can read more about general DEA registrations at Practitioner's Manual - SECTION II. For more information on this specific topic, scroll down the web page to the section titled “Practitioner's Use of a Hospital's DEA Registration Number.”
Note: DEA regulations are within the authority of the DEA, so final determination on the need for DEA registration lies with the DEA and not the Pharmacy Commission.
- May a pharmacist dispense a 12-month supply of a contraceptive drug?
Yes, a pharmacist may dispense a 12-month supply of a contraceptive drug if the prescription is written for an initial supply of 12 months, e.g. 364 tablets of a contraceptive pill. (RCW 48.43.195)
A pharmacist may not dispense a 12-month supply of a contraceptive drug if the prescription is written for a limited initial supply with refills, e.g. an initial 30-day supply with 11 refills. In this situation, a pharmacist is limited to dispensing a 90-day supply of that prescription. (RCW 18.64.520)
- Does the commission need to approve a system used to electronically transmit prescription information to the pharmacy?
No, this requirement was removed by the passage of SSB 5380 (chapter 314, Laws of 2019). Licensees are responsible for confirming the e-prescribing vendor's software meets the federal e-prescribing requirements. These requirements are outlined in federal regulations, 21 CFR 1311 subpart C. Additionally, WAC 246-945-010 provides the requirements of a prescription in Washington state.
- May a pharmacist engage in sterile/nonsterile compounding outside a licensed pharmacy?
Yes, a pharmacist may engage in compounding outside of a licensed pharmacy. If yes, is USP still applicable to the pharmacist?
RCW 18.64.270(2) require pharmacists, and pharmacy personnel the commission credentials to meet USP standards no matter the facility where compounding is taking place.
- May a pharmacist administer flu vaccinations when operating under a CDTA at a patient's home?
A pharmacist would be able to administer vaccines at a patient's home. The pharmacist would still be responsible for the proper packaging and storage of the vaccines while in transit.
- Do I need to adhere to the Washington State Department of Labor and Industries' (L&I) General Occupational Health Standards rules on Hazardous Drugs (i.e., WAC 296-62-500 et al) when handling hazardous drug preparations?
Yes, licensees should be familiar with WACs 296-62-500 through 296-62-50055 when handling hazardous drug preparations. Please view the commission's policy statement on the Regulation of the Handling of Hazardous Drugs (PDF), which includes the expectations for compliance with L&I's rules on Hazardous Drugs as well as the commission's approach to USP 797 and USP 800. Contact L&I with any questions on WACs 296-62-500 through 296-62-50055.
- Can a pharmacist partially fill a schedule II drug if requested by the patient or the prescriber?
A pharmacist may partially fill a prescription for a schedule II controlled substance if the partial fill is requested by the patient or the prescribing practitioner and the total quantity dispensed in all partial fillings doesn't exceed the quantity prescribed (chapter 314, Laws of 2019 – section 7, SSB5380).
- If yes, is USP still applicable to the pharmacist?
RCW 18.64.270(2) requires pharmacists, and pharmacy personnel the Commission credentials to meet USP standards no matter the facility where compounding is taking place.
- How will the commission inspect to or enforce USP standards?
The most appropriate way to enforce USP standards in these scenarios would be complaint-based and not preemptive inspections. Keep in mind the drugs the pharmacist used would need to be purchased, stored, etc. by a health care practitioner licensed to possess those drugs.
- Must a pharmacist engaged in compounding outside a licensed pharmacy need to be supervised by another health care provider?
No. Compounding is explicitly called out in the definition of the "practice of pharmacy." Other pharmacy-credentialed personnel would still require supervision in accordance with state and federal law. The pharmacist would still need to ensure the compounding operation was compliant with applicable chapters of USP and the compounding facility obtained any necessary licenses.
- May a pharmacist fill patient pill boxes/medication planners for a patient at the patient's home?
A pharmacist, like a family member, may fill a patient's medication planner/pill box.
Keep in mind a patient may not bring a prescription bottle filled by Pharmacy A into Pharmacy B and ask for the pills to be repackaged into something else (such as a bubble pack) as Pharmacy B did not fill the prescription. This is considered repackaging.
- May a doctor hire a licensed pharmacy technician at his or her clinic to compound without having a pharmacist on staff?
RCW 18.64A.030(1) states a "'pharmacy technician' may assist in performing, under the supervision of a licensed pharmacist, manipulative, nondiscretionary functions associated with the practice of pharmacy and other such duties subject to such restrictions as the commission may by rule adopt.
WAC 246-901-020(1) also requires pharmacy technicians to be under the immediate supervision of a licensed pharmacist when performing nondiscretionary and specialized functions consistent with their training. Based on the laws quoted above, a pharmacy technician is required to be supervised by a pharmacist. Therefore, if pharmacist technicians are acting within their scope at a clinic or non-pharmacy facility, they still must be supervised by a pharmacist.
- May the technician be hired by the doctor and say "even though I'm a licensed technician, I'm not going to be working under my pharmacy technician license" and work directly for the physician, or would this be considered unlicensed practice because it is a licensed pharmacy technician and this technician is not being supervised by a pharmacist?
Relevant factors include, but are not limited to:
- Does the job advertise as a "pharmacy technician" position?
- Does the person have the job title of "pharmacy technician" or "technician?"
- Does the job require the person to have an active national certification or pharmacy technician credential?
Licensed personnel are able to work in different settings based on their scope of practice. If pharmacy technicians are advertising their services based on their credential, they would have to meet the regulatory requirements and standards for that credential. If pharmacy technicians are not performing the functions of a pharmacy technician and are not advertising those services, they must be credentialed appropriately for the functions/actions they are taking.
- May a pharmacy technician licensed by the Pharmacy Quality Assurance Commission (commission) perform data entry-oriented tasks such as medication order processing remotely from home?
Pharmacy technicians licensed by the commission are not prohibited from working remotely from home. WAC 246-945-315(1) requires that any pharmacy function delegated to a pharmacy technician be performed under a pharmacist’s immediate supervision. The definition of immediate supervision allows the use of technology to ensure real-time, two-way communications between the supervising pharmacist and technician(s) – please see WAC 246-945-001(44). Additionally, RCW 18.64A.040(1) states that a pharmacy technician should only engage in pharmacy functions that are part of a pharmacy’s commission-approved ancillary utilization plan (AUP). Please note that the provision for technicians to perform pharmacy-related functions remotely from home is limited to data entry-oriented tasks. It does not include the physical handling and manipulation of medications or drug products.
- Do I need to include a separate AUP with my pharmacy technician training program application?
Yes. Both the technician training program's AUP and the general AUP mentioned above require two separate approvals by the commission. These are two independent processes with the department. These AUPs may be identical or different depending on the duties/responsibilities specified in the technician training program
- Does an individual's (or businesses') acquisition of more than 50% of the shares in a pharmacy corporation trigger the commission's “change of ownership” process?
Yes, according to statute and rule, pharmacies should immediately notify the commission and comply with the commission's “change of ownership” process if an individual or business acquires more than 50% of the shares in a pharmacy corporation (such as through a stock sale [see RCW 18.64.043(3), WAC 246-945-230(3)(c) and WAC 246-907-040(2)]). If there are other change of ownership questions, please contact us.
- Can an unfilled original electronic prescription of a Schedule II controlled substance be transferred?
On August 27, 2020, the commission reaffirmed its position, consistent with the DEA, of permitting the transfer of an unfilled original electronic prescription for a Schedule II controlled substance from one DEA-registered pharmacy to another DEA-registered pharmacy. The commission encourages pharmacies engaging in the transfer of any unfilled original electronic prescription of a Schedule II controlled substance to maintain an audit trail as defined in WAC 246-945-001(6).
- Under the legislature's new compounding law (SHB 1445), should I continue to follow USP requirements when diluting a reconstituted sterile medication, such as Remicade, according to federal food and drug administration-approved labeling?
Yes, the new compounding law exempts non-sterile and sterile products that only require reconstitution and mixing according to FDA-approved labeling. Further manipulation of a reconstituted product, such as dilution, should be an indicator that compounding is occurring and USP should be followed, per RCW 18.64.270(2). Additionally, under the new pharmacy standard of care rules, the commission expects pharmacists to utilize their professional judgment in the best interest of the patient.
Please note: This law became effective July 25, 2021.
- Can a pharmacy supply naloxone to an entity that is not licensed by DOH or to an individual not credentialed by the DOH?
Yes, under the “Standing Order to Dispense Naloxone” pharmacists are authorized to dispense naloxone to any “eligible person or entity.” The commission will not take enforcement action against a pharmacist or pharmacy for supplying naloxone in good faith and with reasonable care to a non-credentialed entity or non-credentialed provider in accordance with RCW 69.41.095 and the statewide naloxone standing order.
An example may include a pharmacy providing naloxone to a behavioral health clinic or provider not credentialed by DOH for the purpose of treating substance use disorder in accordance with RCW 70.41.480 and RCW 71.24.594.
Note: An eligible person or entity is any person at risk of experiencing an opioid-related overdose or any person or entity in a position to assist a person at risk of experiencing an opioid-related overdose. These could include a natural person, such as an individual at risk of an opioid-related overdose or a family member, friend or acquaintance of that individual; or a legal person, such as an ambulance service, police department, or school or other educational institution that could be in a position to assist a person at risk of experiencing an opioid-related overdose.
- Should a label be affixed to a pre-drawn COVID-19 vaccine syringe? If so, what information should the label include?
It is important to appropriately label any pre-drawn syringe to minimize the risk of administration errors and vaccine mix-ups. This includes pre-drawn syringes of the COVID-19 vaccine. A label should be affixed to a syringe so that the markings on the barrel of the syringe are not obscured and pertinent label information is easily visible and legible. In keeping with WAC 246-945-018 and per guidance from the Centers for Disease Control and Prevention (CDC) and the United States Pharmacopeia (USP), best practices for pertinent label information include:
- The vaccine name and amount
- The expiration date and exact beyond-use date and time
- Lot number
- Initials of preparer(s)
At a minimum, the label should include the information specified in WAC 246-945-018. Other rules may be applicable under certain conditions.
While the CDC notes that the safest practice is to draw up a dose of COVID-19 vaccine immediately before administration, the Washington State Department of Health recognizes that there are circumstances in which the use of a pre-drawn syringe is necessary. Please consult the CDC website for current beyond-use dating for COVID-19 vaccines, and for further guidance related to storing and handling pre-drawn COVID-19 vaccine syringes.
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