Chapter 246-945 WAC

Frequently Asked Questions

Part 1 – General Provisions

Easy-open Cap Authorizations. Is there any documentation required for easy-open, not child-resistant container authorizations?

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.

Subpart D: Home Dialysis

Subpart E: Compounding minimum standards

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 6/1/2018 and then completed a second inventory on 6/1/2020, even if the anniversary of the issuance of the registration was 1/1/2020. This is because the inventory on 6/1/2020 was taken within two years of the inventory on 6/1/2018.

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.

Part 2 – General Licensing

How many continuing pharmacy education (CPE) credit hours must I complete to renew my pharmacist credential?

Pharmacists must complete the equivalent of 30 hours of continuing pharmacy education (CPE) administered by an ACPE accredited provider to be eligible for license renewal pursuant to WAC 246-945-178.

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;
• 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.

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.

How many continuing pharmacy education (CPE) credit hours must I complete to renew my pharmacy technician credential?   

Pharmacy technicians must complete 20 hours of continuing education administered by an ACPE-accredited program to be eligible for certification renewal pursuant to WAC 246-945-220.

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 its 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.

Part 3 – Professional Standards

Do tech-check-tech training programs or other specialized functions performed by technicians require commission approval under the new rules?

No, there are no specific training requirements for pharmacy technician specialized functions under the new rules. However, WAC 246-945-315(2)(a) states that when delegating a pharmacy function to a pharmacy technician, "A pharmacist shall consider the pharmacy technician's scope of practice, education, skill, and experience and take them into account." Lastly, the additional function (formerly the specialized function) must be included in the AUP, which still requires commission approval.

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.”

Part 4 – Operational Standards

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. A breakdown of required policies and procedures by facility type is located on the commission’s website (see Required Policies and Procedures in Chapter 246-945 WAC (PDF)).

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”. Immediate supervision is defined 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.

Do licensed health care entities (HCE) who have medications stored on-site that are supplied and remain under the control of a pharmacy have to comply with WAC 246-945-455?

Yes.