MO Board of Pharmacy Update

HEALTHCARE PROVIDER VACCINE ASSISTANCE

The Board has been asked if pharmacies can use non-pharmacy healthcare providers to help provide both COVID-19 and non-COVID-19 vaccines (e.g., nurse, physician assistant, assistant physician). Pharmacies may use non-pharmacy healthcare providers to administer vaccines subject to the following:

1. The healthcare provider has their own authority or their own protocol/standing order with a physician, in compliance with their regulatory agency’s requirements, that gives them the authority to administer the vaccine.
2. The healthcare provider administers the vaccine in compliance with their authority or protocol/standing order, including, any patient screening requirements.
3. The pharmacy may use their pharmacy software system to conduct billing/vaccine reporting for administrations provided by a healthcare provider. If a prescription number is assigned to the billing/reporting record, the computer record and any hard copy or image should clearly indicate that it is a billing record and not a prescription record.
4. The pharmacy must be able to account for pharmacy vaccine inventory administered by the healthcare provider via billing or distribution records.
5. For healthcare provider-administered vaccines, any hard copy vaccine administration record should be physically separated from pharmacy administration records.
6. The healthcare provider administering does not have to be registered as a pharmacy technician, unless they will have independent access to drug inventory (e.g., without a pharmacist present and supervising).

 

Disclaimer: This procedure has not been reviewed for insurance billing and liability concerns. For legal advice, please consult an attorney.  Healthcare providers should contact their licensing Boards for their requirements.

 

Reminder:  Compounding With Bulk Drug Substances

 

Please be aware that federal requirements are stricter than Missouri’s regulations when compounding with bulk drug substances. Below is an excerpt on 503A pharmacy compounding from FDA’s website:

 

Bulk drug substances

Bulk drug substance must be accompanied by a valid certificate of analysis and must have been manufactured by an establishment registered with FDA under section 510. In addition, the bulk drug substance must comply with an applicable United States Pharmacopeia (USP) or National Formulary (NF) monograph, if one exists, and the USP chapter on pharmacy compounding; if an applicable USP/NF monograph does not exist, be a component of an FDA-approved drug; or if such a monograph does not exist and the substance is not a component of an FDA-approved drug, appear on a list of bulk drug substances that can be used in compounding under section 503A developed by FDA through regulations.  Section 503A(b)(1)(A). See also, FDA’s final guidance describing its interim policy for compounders using bulk drug substances while the list of bulk drug substances is being developed.