Saturday, August 10, 2013

Washington Board of Pharmacy New Laws Implemented in 2013 Legislative Session


New Laws Implemented in 2013 Legislative Session

The 2013 legislative session changed pharmacy laws that may affect you or your practice. Here’s a list of those bills and the schedule to include the changes into administrative rules. 



Resident and Nonresident Pharmacy Compounding

HB 1800
Law Effective May 7, 2013

"Manufacture" is defined to include distributing a pharmacy-compounded drug to other licensed people or businesses to sell or distribute, unless the Pharmacy Quality Assurance Commission has approved a product. The term “manufacture” doesn’t include: (a) a pharmacy that compounds a product or provides it to a practitioner to give to patients; (b) a pharmacy repackaging medication in small amounts for office use by a practitioner; (c) distributing a drug product a pharmacy has compounded to other licensed entities the compounding facility owns or controls; or (d) delivery of finished compounded products dispensed with a prescription to other locations, other than the patient's home, when asked for by the patient or the prescriber to give to the patient, or to another pharmacy to dispense to the patient.
Also, the law says any medicinal products compounded for patients or for distribution to a practitioner for patient use must meet official United States Pharmacopeia standards as they apply to nonsterile and sterile products.
The commission filed public notice to begin rulemaking on May 20, 2013. The commission will review nationally recognized pharmaceutical compounding standards as it updates and establishes practice standards for compounding sterile and nonsterile preparations in all pharmacy practice.
The Pharmacy Quality Assurance Commission anticipates rule adoption in early summer 2014.

Redistribution of Medications Under Certain Conditions

SSB 5148
Law Effective July 1, 2014

The law allows a pharmacy to redistribute prescription drugs and supplies donated by certain medical professionals and drug manufacturers or wholesalers, without compensation, to another pharmacy, pharmacist, or prescribing practitioner.

Donated medications and supplies must be given to uninsured or low-income people, or to others if an uninsured or low-income person can’t be found. A pharmacist must verify that the prescription drug is in the original and sealed package or, if opened, that it is in unit-dose packaging. The prescription expiration date must be more than six months after the date it was donated, the prescription drug must not be recalled by the manufacturer, and the prescription drug must meet the criteria set by the Department of Health.
The Pharmacy Quality Assurance Commission expects rule development to begin fall 2013.

Medical and Pharmacy Management – Standardized Prior Authorization

SB 5267 – Chapter 215, Laws of 2013
Law Effective July 28, 2013

This law establishes a work group to make the prior approval process for prescription drugs, medical procedures, and medical tests easier and quicker. The insurance commissioner will adopt rules by January 1, 2015 using the work group’s suggestions.

Electronic Prescription Information

SB 5416 – Chapter 276, Laws of 2013
Law Effective July 28, 2013

This bill changes the definition of electronic communication and changes sections of the Uniform Controlled Substances Act to mirror federal law regarding the electronic submission of controlled (Schedule III-V) medications.
The law establishes that a Schedule II controlled substance (CS) may not be filled more than six months after the date the prescription is issued. Formerly, Schedule II prescriptions defaulted to the one-year expiration for a non-CS prescription in WAC 246-869-100(2)(d). In addition, the law says prescriptions for Schedule III through V may not be filled or refilled beyond six months from the issue date or refilled more than five times, unless the practitioner renews them. Also, the law says a Schedule V CS may be dispensed only with a prescription or directly by the practitioner allowed to prescribe or administer.
This new section replaces standards in WAC 246-887-030. The Pharmacy Quality Assurance Commission expedited rule development has started. Rules may be adopted fall 2013.

Requiring 90-Day Supply Limits on Certain Drugs

SSB 5459
Effective July 28, 2013

This law allows, a pharmacist (in his or her professional judgment) to dispense up to a 90-day supply of a drug (except controlled substances) when a prescription is for an initial quantity of less than 90-day supply with refills. The prescription must meet the following conditions:
  • The patient has completed an initial 30-day supply or the prescription continues the same medication previously dispensed in a 90-day supply.
  • The total quantity of doses does not total more than the prescriber authorized including refills; and
  • The prescriber hasn’t specifically said it is medically necessary to dispense in the initial amount followed by refills.

Allowing Washington Pharmacies to Fill Prescriptions Written by Physician Assistants in Other States

SSB 5524
Effective July 28, 2013

This law allows Washington State pharmacies to dispense non-controlled prescriptions written by physician assistants and osteopathic physician assistants licensed in another state or in British Columbia, Canada. Washington State pharmacies may also dispense prescriptions for CS that are written by out-of-state physician assistants and osteopathic physician assistants as long as they registered with the DEA. Find who can prescribe and administer prescriptions  in Washington State.

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