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Upon initial licensure and at renewal, RCW 18.64.360(1)(b) requires a nonresident pharmacy to submit a copy of an inspection report issued within the last two years that was conducted by an inspection program and approved by the Pharmacy Quality Assurance Commission (commission/PQAC) as having substantially equivalent standards to those of the commission. This directive identifies those inspection programs the commission has approved as having substantially equivalent standards to those of the commission. The commission reviewed and approved an updated version of this directive at the December 17, 2021, commission meeting.
The PQAC considered multiple factors when choosing whether to approve an inspection program. This includes using the National Association of Boards of Pharmacy (NABP) Multistate Pharmacy Inspection Blueprint Program criteria. The commission also considered whether the inspection program required nonresident pharmacies who engage in compounding to comply with the minimum standards of the official United States Pharmacopeia (USP).
Please click for the current Nonresident Pharmacy Directive. You can also locate it on the Pharmacy Commission Policies and Procedure webpage.
Q: 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?
A: PQAC 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 in compliance, 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.
For this FAQ and others please see Chapter 246-945 WAC FAQs
Q: Can a pharmacy supply naloxone to an entity that is not licensed by DOH or to an individual not credentialed by the DOH?
A: Yes, under the “Standing Order to Dispense Naloxone” pharmacists are authorized to dispense naloxone to any “eligible person or entity.” PQAC 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 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.
For this FAQ and others please see General Pharmacy Practice FAQs
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