Embedded Files
A Quarterly Newsletter of the State Board of Pharmacy
Board reminds pharmacists
about new accessibility law
Board reminds pharmacists
about new accessibility law
On June 3, 2024, Gov. Jared Polis signed HB24-1115, Prescription Drug Label Accessibility, into law and on October 3, 2024 the Board of Pharmacy adopted Rules to implement this bill, which go into effect early December.
This bill requires pharmacies to provide patients a method to access prescription drug label information to a patient who notifies a pharmacy of difficulty seeing or reading standard printed labels on a prescription drug container, on or after July 1, 2025.
The patient may choose:
an electronic label affixed to the prescription drug container that transmits prescription drug label information, directions, and written instructions to a patient’s external accessible device;
a prescription drug reader provided to the patient at no cost;
a prescription drug label in braille or large print; or,
any other method included in the best practices for access to prescription drug labeling information by the United States Access Board.
Although the Board affirmed an alternative method process by rule, the bill itself provides clear language on requirements for licensees and registrants.
Adopted Rules from Legislative Session Available
Adopted Rules from Legislative Session Available
The Colorado Board of Pharmacy met on Oct. 3, 2024 to review numerous changes in rules that have gone through the stakeholder process over the last year and some of which required rulemaking from the 2024 legislative session. The Board adopted the rules as amended. More information can be found here under the Public Notices banner. Rules will take about 60 days to take effect after they’ve had the necessary legal review and administrative processes and are anticipated to go into effect near the beginning of December.
FDA info available for Compounding during shortages
FDA info available for Compounding during shortages
The Food and Drug Administration (FDA) understands that when a drug is in shortage, patients and health care professionals may look to compounded drugs as an option to get the medication they need.
Generally, when an FDA approved drug is on the FDA’s drug shortages list some federal law restrictions may be lifted, such as restrictions on compounding drugs that are essentially copies of approved drugs. However, other requirements remain, and compounded drugs may not be able to meet these federal law restrictions. More information is available here for prescribers, patients, and pharmacies.
Tirzepatide Injection Shortage Clarification
Tirzepatide Injection Shortage Clarification
The FDA's Center for Drug Evaluation and Research (CDER) Division of Drug Information has issued a clarification stating it has determined the shortage of tirzepatide injection has been resolved and reminding compounders about the legal restrictions related to compounding copies of FDA-approved drugs.
The clarification references and links to relevant 503A and 503B compounder guidances and the FDA Drug Shortage Database, and lists the current shortage status of other GLP-1 products.
VERIFY AND UPDATE PATIENT ADDRESSES
The Colorado State Board of Pharmacy and the Colorado Prescription Drug Monitoring Program (PDMP) would like to remind licensees and registrants of the importance of verifying and updating patient addresses when dispensing prescriptions, especially when a patient has an out-of-state address on file with the pharmacy.
The Colorado PDMP’s patient matching algorithm may fail to properly consolidate patient records when pharmacies report controlled substance dispensations with an out-of-state patient address.
ANNUAL TAKE BACK DAY SCHEDULED OCT. 26
ANNUAL TAKE BACK DAY SCHEDULED OCT. 26
The Drug Enforcement Administration (DEA) will hold its 26th Annual Take Back Day on Saturday, Oct. 26 from 10 a.m. to 2 p.m. at locations nationwide.
Community members can drop off unused and unwanted medications and prevent drug misuse before it starts. More information is available here.
For those who can't make the in-person event, year-round drop boxes are available at pharmacy and medical facility disposal locations, listed here.
More from the DEA
More from the DEA
safety alert video available after slew of non-chain burglaries
safety alert video available after slew of non-chain burglaries
The DEA has seen a surge in burglaries at independent, non-chain pharmacies. Nearly 900 burglaries involving the theft of controlled substances were reported to the DEA in 2023.
Criminals steal controlled substances and sell them on the streets, impacting both patient care and public safety.
A new safety alert video shows pharmacies how they can avoid becoming the next victim and educates the public on this crime.
Additional resources, including crime data, and comprehensive materials for pharmacists is available here.
Take These Steps to Help Protect Your Company from Cyber Attacks
Take These Steps to Help Protect Your Company from Cyber Attacks
The DEA has seen several cyber attacks on healthcare and drug companies that resulted in data breaches.
To avoid becoming the next victim, there are measures companies can take.
The DEA recommends that registrants implement safe cybersecurity best practices, including:
using strong and unique passwords/passphrases;
keeping software up-to-date;
thinking before clicking suspicious links or opening unexpected attachments;
turning on multi-factor authentication (MFA); and,
safeguarding accounts from unauthorized access.
DEA registrants should also regularly review their prescribing activity through the Prescription Drug Monitoring Program and flag any discrepancies.
If you experience or witness a potential cyber incident with a DEA system or data, report it to DEACORE@DEA.gov. More information is available here.
NABP offers digital tools to boost communication, public health
NABP offers digital tools to boost communication, public health
Pulse by NABP is an inclusive, accessible, and secure digital platform that simplifies DSCSA compliance.
Pulse provides access to user-friendly tools and a comprehensive network of verified relationships, enabling consistent communication with regulators and drug supply chain trading partners.
As a 501(c)(3) nonprofit association whose mission is to protect public health, the National Association of Boards of Pharmacy (NABP) is uniquely positioned to be an independent and impartial source of information that can connect trading partners with the goal of enabling DSCSA compliance. For over 120 years, NABP has protected public health by assisting its member boards of pharmacy and offering programs that promote safe pharmacy practices for the benefit of consumers.
NABP’s members include the boards of pharmacy in all 50 United States, the District of Columbia, Guam, Puerto Rico, the Virgin Islands, and 10 Canadian provinces.
Questions?
Questions?
dora_pharmacyboard@state.co.us
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