Board of Pharmacy: Emergency Revision of 20 CSR 2220-2.650

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Emergency Revision of 20 CSR 2220-2.650 (Class-J Shared Services) 

The Board recently filed an emergency rule amending 20 CSR 2220-2.650 (Class-J Shared Services) that became effective on August 6, 2017.  This memorandum provides general compliance information on the emergency rule provisions.  The full emergency rule is available on the Board’s website.  Licensees should read the rule in its entirety to ensure compliance with Missouri law. 

WHY WAS THE RULE CHANGED?

In April 2017, the Board received comments from Missouri pharmacies indicating 20 CSR 2220-2.650 was detrimentally impacting medication delivery to high-risk and lower income patients.  Specifically, the Board was informed that patient assistance programs and third party payors are increasingly mandating that certain medications can only be prepared/dispensed by a specialty pharmacy and shipped to another licensed pharmacy for onsite administration to the patient by a healthcare provider. 

Under the previous 20 CSR 2220-2.650, both the pharmacies receiving and shipping the medication were required to hold a Class-J pharmacy permit.  Licensees reported this requirement was impacting care for patients who may need medication before a Class-J contract could be negotiated.  In some instances, the receiving pharmacy may be unknown or have no prior business relationship with the specialty pharmacy.  As a result of the receiving pharmacy being unable to accept medication without a Class-J permit, patients were reportedly being denied treatment or experiencing significant medication delays, including cancer and other high-risk Missouri patients.    In response to the public action requests, the Board filed an emergency rule that became effective on August 6, 2017.

WHAT WAS CHANGED?

The emergency rule: (1) clarifies the shared records/database requirement for Class-J pharmacies and (2) creates a Class-J permit exemption for medication transferred between pharmacies for onsite administration.

Shared Database/Records

20 CSR 2220-2.650(1)(A) has been amended to clarify that Class-J pharmacies must share a common database or allow access to each pharmacy’s electronic medication or prescription records. The access must provide real-time online access to the patient’s complete profile for the pharmacies involved. 

Class-J Permit Exemption

The emergency rule exempts Missouri licensed pharmacies from having a Class-J Shared Services permit if:

  1. A completed and labeled prescription is delivered from one Missouri licensed pharmacy to another Missouri licensed pharmacy; and
  2. The medication will be administered to the patient by a pharmacist or other licensed health care professional on the same premises or physical location as the pharmacy.  Administration is defined as applying or introducing medication to the body of a patient, whether by injection, infusion, inhalation, ingestion or other means.

The emergency exemption only applies if a completed and labeled prescription is delivered to the receiving pharmacy.  The receiving pharmacy must maintain documentation of the medication received, the name and address of the pharmacy providing the medication, the receipt date and the patient’s name.  If additional manipulation or compounding is required by the receiving pharmacy, the receiving pharmacy has to receive a valid prescription or medication order and the product/preparation has to be dispensed as the receiving pharmacy’s own prescription/order.

Significantly, the emergency exemption does not exempt entities from all Board licensure.  The emergency rule only exempts licensed Missouri pharmacies from having an additional Class-J designation.

WHEN IS THE EMERGENCY RULE EFFECTIVE?

August 6, 2017. 

HOW DO I UPDATE MY PERMIT?

A Pharmacy Change of Classification Application can be submitted to remove Class-J from your current permit.  No fee will be charged if the application indicates that Class-J is being deleted because of the rule change.

Questions?

E-mail the Pharmacy desk at pharmacy@pr.mo.gov or contact your inspector.

***  This document does not constitute a rule statement of general applicability or binding law. In the event of a conflict or inconsistency, duly promulgated or enacted law shall control. The Board expressly reserves the right to revise the contents as deemed appropriate or necessary.