Pharmacy Practice

Frequently Asked Questions

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.

May a pharmacist fill patient pill boxes/medication planners for a patient?

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.

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.  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?

RCW 18.64.265 states 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.

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)

If a pharmacist receives an oral, faxed, or written prescription, is that pharmacist required to first verify that the prescriber has been granted an exemption to the e-prescribing requirement, before filling the prescription?

No. RCW 69.50.312(4) states, “A pharmacist who receives a written, oral, or faxed prescription is not required to verify that the prescription properly meets any exemptions under this section. Pharmacists may continue to dispense and deliver medications from otherwise valid written, oral, or faxed prescriptions.” Pharmacists should not refuse to fill valid prescriptions simply because they have not been transmitted to the pharmacy electronically.

May a pharmacist engage in sterile/nonsterile compounding outside a licensed pharmacy?

Yes, a pharmacist may engage in compounding outside of a licensed pharmacy. 

RCW 18.64.270(2) requires pharmacists and pharmacy personnel with 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 patient-specific vaccines at a patient's home. The pharmacist would still be responsible for the proper packaging and storage of the vaccines while in transit.

Can pharmacy technicians engage in remote medication order processing or perform order entry from a remote location?

Yes, but pharmacists should ensure ancillary personnel or interns are supervised in a manner that meets the commission definition of “immediate supervision”. Immediate supervision is defined in WAC 246-945-001(44). This includes the ability of pharmacists to employ technological means for the supervision of ancillary personnel or interns remotely. Pharmacists are encouraged to review WAC 246-945-001(44) in its entirety when remotely supervising ancillary personnel or interns. 

Does the Uniform Controlled Substances Act (RCW 69.50) restrict the quantity of controlled substances that may be prescribed?

The Uniform Controlled Substances Act (UCSA), chapter 69.50 RCW, does not limit the quantity of controlled substances (including those drugs listed in Schedule II) that may be prescribed. However, prescribers and pharmacists should be aware of specific prescribing laws that may apply to their profession. For example, a number of prescribing boards and commissions have specific laws and rules applicable to prescriptions for opioids. The USCA does prohibit refills for a drug listed in Schedule II (see RCW 69.50.308(d)). The USCA also prohibits filling of a prescription for a drug listed in Schedule II more than six months after the date the prescription was issued (see RCW 69.50.308(d)). The USCA prohibits more than five refills of a prescription for a drug listed in Schedule III, IV, or V (see RCW 69.50.308(g)). In addition, the USCA prohibits filling or refilling of a prescription for a drug listed in Schedule III, IV, or V, more than six months after the date issued by the prescriber (see RCW 69.50.308(g)).

  Can a prescription for a substance included in Schedule II be dispensed upon the oral prescription of a practitioner?

A substance included in Schedule II may be dispensed upon the oral prescription of a prescriber in an emergency (RCW 69.50.308(c)). Further guidance can be found in WAC 246-945-010(6).

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 (PDF).

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.

Another example may include a hospital pharmacy and its staff providing naloxone to a patient upon discharge from inpatient care.  
 
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.

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)).

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 pharmacy’s general AUP require two separate approvals by the commission. These are two independent processes. These AUPs may be identical or different depending on the duties and responsibilities   specified in the technician training program.  

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 commission.

For additional information on CDTAs see the commission's 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.

For example: 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 III. For more information on this specific topic, scroll down the web page to the section titled “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 commission.

(From PQAC Newsletter No. 1283 Practitioner DEA Registrations, April 2018) (PDF))

Can a pharmacy use transportation network companies (TNCs) such as Uber, Lyft, or Postmates to deliver a patient’s prescription medication?

Possibly: Under Washington law, a TNC could transport a patient’s prescription medication if they are a “common carrier” or “contract carrier” (see RCW 69.41.030(1)). If a TNC is a “common carrier” or “contract carrier” the TNC would have to obtain a permit from the Washington State Utilities and Transportation Commission (UTC) unless they are exempt. Pharmacies should contact the UTC to verify the status of a “common carrier” or “contract carrier”. Pharmacies should consider other applicable laws and other regulators (e.g., United States Drug Enforcement Administration) before using TNCs to deliver a patient’s prescription medications. For example, the DEA has stated registrants are responsible for selecting common or contract carriers that will provide adequate security against in-transit losses or thefts.

Where can I find printable signage indicating “contraceptives prescribed/dispensed here?"

Pharmacies seeking to locate and display printable signage indicating “Contraceptives Prescribed & Dispensed Here” may see the following information on the Washington State Department of Health website's Pharmacy Contraceptive Sign (wa.gov)(PDF). RCW 18.64.008.

May a pharmacy sell and distribute sterile hypodermic syringes and needles without a prescription?

Washington law permits a pharmacist to distribute sterile hypodermic syringes or needles without a prescription, including hypodermic syringes or needles used for subcutaneous or intramuscular injections (RCW 69.50.4121(3)). Washington law also requires that a pharmacist who sells a hypodermic needle or syringe at retail “shall satisfy himself or herself that the device will be used for the legal use intended” (RCW 70.115.050). The Commission has previously determined, and continues to maintain, that the sale of sterile hypodermic syringes and needles for the purpose of reducing the transmission of blood-borne diseases is a legal use under RCW 70.115.050.

Is any documentation required to authorize the provision of medications in easy-open cap or non-child-resistant containers?

No, neither WAC 246-945-032 or 16 C.F.R. Part 1700 require pharmacies to obtain documentation that a patient wishes to receive their medication in a container that is not child-resistant.

The commission would recommend as a best practice that a pharmacist obtain a request in writing from a patient who requests their medication be dispensed in a container that is not child-resistant to assist during inspections.

How can the holder of a “Drug Other Controlled Substance Registration” comply with the requirement to perform an inventory every two years on the anniversary of the issuance of the registration, as required by WAC 246-945-060(4), if the holder is not aware of the anniversary date for their registration or is otherwise unable to complete the inventory on the anniversary date?

The commission will not find a holder of a “Drug Other Controlled Substance Registration” deficient or in violation of the requirement to perform an inventory on the anniversary of the issuance of their registration in WAC 246-945-060(4) so long as the registrant ensures that each inventory is taken within two years of the previous inventory. The registrant should also ensure that all other provisions of WAC 246-945-060(4) are complied with, such as maintaining the inventory list for two years.

For example, the holder of a “Drug Other Controlled Substance Registration” would not be found to be in violation of WAC 246-945-060(4) if they completed an inventory on June 1, 2023 and then completed a second inventory on June 1, 2025, even if the anniversary of the issuance of the registration was January 1, 2025. This is because the inventory on June 1, 2025 was taken within two years of the inventory on June 1, 2023.

This position is consistent with the inventory requirements of the United States Drug Enforcement Administration (DEA) for each location registered with the DEA (21 C.F.R. §§ 1304.04 and 1304.11). Additionally, the commission believes this position protects the public health and will not undermine efforts to reduce diversion of controlled substances.

How do pharmacy interns request commission permission to renew pharmacy intern credentials for the fourth or subsequent time?

To request an additional renewal from the commission beyond the 3 permitted in WAC 246-945-155, a pharmacy intern must email the Pharmacy commission before completing the renewal application with the following information: 

Name; Intern registration number;

 

The commission will make every effort to timely process these requests; however, requesting pharmacy interns should assume that these requests take up to 60 days to process.

• Intern registration expiration date;
• Explanation of the reason for the request; and
• Documentation for how the intern meets all other requirements of RCW 18.64.080 and WAC 246-945-155.

 

Differential Hours - Is it still required to report changes in differential hours?

No, there is no longer a requirement to report ‘differential hours' under chapter 246-945 WAC for a pharmacy located within another establishment. Therefore, a pharmacy does not need to submit an application when its hours of operation changes. However, pharmacies are encouraged to post their hours of operation at the entrance when located within another mercantile establishment.

Are there any commission-recognized third-party inspection programs for out-of-state wholesalers?

Yes, the commission recognizes the National Coalition for Drug Quality & Security (NCDQS) as well as NABP's Drug Distributor Accreditation program (formerly known as VAWD) as a third-party inspection programs for wholesaler applicants located outside of Washington State.

As stated in WAC 246-945-246(3)(a), wholesaler applicants located outside of Washington State need to include a site inspection report conducted by the regulatory authority in its resident U.S. jurisdiction, or third-party inspection report from a program recognized by the commission with their application.

What is a prescription transfer?

A prescription transfer is a transfer of a prescription between pharmacies. The commission requirements addressing prescription transfers are found in WAC 246-945-345.

Do all prescription transfers need to be transferred by electronic means?

All prescription transfers for non-controlled drugs need to be transferred by electronic means, including facsimile, except in emergencies. Controlled drug prescription transfers must conform to 21 C.F.R. 1306.08(f) and 21 C.F.R. Sec.1306.25.

What qualifies as an emergent situation as it relates to noncontrolled prescription transfers in WAC 246-945-345(5)?

Whether a situation is “emergent” is dependent on the pharmacist's professional judgment and the best interest of the patient. The commission encourages pharmacists to contact their pharmacy inspector with questions about specific situations.

While not a requirement, the commission does consider it a best practice to document the decision to transfer a prescription verbally.

How does the commission define “verbal prescription” in WAC 246-945-320(1)(a)?

At the August 27th, 2020 commission meeting, the commission stated that the term “verbal prescription” used in WAC 246-945-320(1)(a) is synonymous with the term “oral prescription” used elsewhere in chapter 246-945 WAC. WAC 246-945-010(7) and (8) state that an “oral prescription" must be promptly reduced to a written or electronic prescription that complies with WAC 246-945-011.”

Can transferring a prescription by electronic means be delegated to a pharmacy technician?

Yes, a pharmacy technician may transfer a noncontrolled prescription under the immediate supervision of a pharmacist by electronic means (including facsimile). The commission considers the function of transferring a noncontrolled prescription by electronic means (including facsimile) to be a nondiscretionary function associated with the practice of pharmacy that is delegable to a pharmacy technician pursuant to WAC 246-945-315. The commission understands this is a change from the previous rules, but acknowledges the importance of adapting to the future advancement in pharmacy practice and patient care services.

However, the transfer of verbal (or oral) prescriptions to another pharmacy cannot be delegated to a pharmacy technician. Further, pharmacy technicians are NOT permitted at any time to transfer verbal or non-verbal controlled substance prescriptions according to the DEA and the commission's promulgated rules.

Is a prescription transferred to a pharmacy by fax and uploaded to the patient medical record (PMR) an electronic prescription?

No, a transfer via fax that is uploaded or scanned to the PMR is not considered an electronic prescription (21 CFR Sec 1306.25(5) and RCW 69.41.055(1)).

Are transfers of noncontrolled drug prescriptions to out-of-state pharmacies required to be completed via electronic means or facsimile?

Resident pharmacies must transfer prescription information for noncontrolled drugs by electronic means or facsimile within three business days of receiving the request or within a time frame that does not adversely impact the provision of medication therapy, whichever comes first, except in emergent situations (WAC 246-945-345). Electronic means is defined as “an electronic device used to send, receive, and/or store prescription information, including computers, facsimile machines, etc.” (WAC 246-945-001(30)). This requirement applies to transfers of noncontrolled drug prescriptions to other resident and out-of-state pharmacies.

An out-of-state pharmacy must comply with the applicable law in their home state when transferring noncontrolled drug prescriptions to a resident pharmacy licensed by the commission.

Do pharmacists licensed in other states need a Washington state pharmacist license to provide pharmacy services to individuals in Washington state?

It depends. Per WAC 246-945-145, “An individual providing pharmacy services to individuals located in Washington is required to be credentialed by the commission unless the individual is providing pharmacy services within the scope of their employment, or affiliation, with a Washington licensed nonresident pharmacy or the law otherwise permits the practice.”

Which facilities need to have policies and procedures in place and for what?

All licensed facilities will need to have policies in procedures in place specific to their type of license. Please see the list of required policies and procedures located on the commission’s Policies, Procedures, and Guidelines webpage.  

What rules apply to pharmacies storing, dispensing, and delivering drugs to patients without a pharmacist on-site?

In addition to the generally applicable pharmacy laws and rules that apply to pharmacies, WAC 246-945-430 contains specific requirements for pharmacies storing, dispensing, and delivering drugs to patients without a pharmacist on-site. Further, WAC 246-945-420 requires pharmacies that exclusively store, dispense, and deliver drugs to patients without a pharmacist on-site to maintain a perpetual inventory.

While the commission does not evaluate an individual pharmacy's model, examples of such situations which would require compliance with WAC 246-945-430 and WAC 246-945-420(4) would include, but are not limited to, pharmacies that dispense and deliver medications via a pharmacy technician without a pharmacist physically on-site, or pharmacies that dispense and deliver medications via technological means without pharmacy personnel physically on-site.

Can a pharmacist supervise ancillary personnel or interns remotely?

Yes, but pharmacists should ensure ancillary personnel or interns are supervised in a manner that meets the commission's definition of “immediate supervision” in WAC 246-945-001(44). This includes the ability of pharmacists to employ technological means for supervision of ancillary personnel or interns remotely. Pharmacists are encouraged to review WAC 246-945-001(44) in its entirety when remotely supervising ancillary personnel or interns.