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March 2021
Happy Passover, Happy Holy Week, and Happy Easter!

Spring is finally here. Everyone will soon be able to get the COVID-19 vaccines. We are turning the corner.

This is a time to reflect, renew, and reset. We will most likely not be returning to "normal", but we can build a new one - a new set of habits and routines for success and happiness.

This week, as I take time to reflect on a year of loss, pain, and uncertainty, I invite you to join me in springing forward, to be better, to be kinder, and to be more open to what is yet to come.

With faith, hope, and gratitude,

Mei
Sterile Compounding:
Avoiding Microbial Contamination
Sterile compounding pharmacies are required to perform viable surface and viable air samplings at least every 6 months.

The sampling tests must be conducted by volumetric methods under dynamic conditions that simulate actual production. Compounding of drug preparations for distribution or use in California must meet the United States Pharmacopeia-National Formulary standards.

What do you do if there is microbial contamination?
Objectionable organisms that are considered highly pathogenic need to be immediately remedied with the assistance of a microbiologist, infection control professional, or industry hygienist. UPS <797> provides recommended action levels for viable air and surface sampling. Any microbial recovery that exceeds the pre-established action level should prompt an investigation into compliance with the organization's policies and procedures. In addition, there should be an immediate investigation of cleaning and compounding operations and facility management. Per UPS <797>, the source of the problem is to be removed, the affected area cleaned, and a resampling to be performed.

Relevant Laws/Regulations:
Title 16, California Code of Regulations, section 1751.4 / Business and Professions Code section 4126.8
Providing Language Translation Services
Pharmacies are required to...

  • Provide free interpretive services to help patients with limited or no English proficiency.
  • Have written policies and procedures in place to ensure patients are able to understand information on their prescription labels.
  • Provide interpreter services during the pharmacy's open business hours.
It is the responsibility of the pharmacies to provide translation services to patients at no cost. Pharmacies can engage internal resources, patient's family members, or third-party solutions such as LanguageLine Solutions for translation needs. LanguagreLine provides on-demand interpreters via audio or video in over 240 languages, 24 hours a day, 7 days a week, 365 days a year.
Pharmacy Regulatory Updates
New 2021 Pharmacy Laws in California
Please click on the headers for more details or visit the CA State Board of Pharmacy.


Pharmacists authorized to independently order and administered COVID-19 vaccines authorized and approved by the FDA.

This law extends, until January 1, 2026, an existing law that authorizes physicians and pharmacists to provide hypodermic needles and syringes for individuals 18 or older without a prescription or permit.

Requires licensing boards to expedite license applications for people admitted to the U.S. as refugees, granted asylum by the Secretary of Homeland Security or the Attorney General of the United States, and holders of special immigrant visas.

The annual CURES fee is increased to $11 from April 1, 2021, through March 30, 2023. Effective April 1, 2023, the annual CURES fee will reduce to $9.

Requires licensing boards to post information regarding time for initial and renewal licenses and processing times for each license the Board administers.

This law provides a one-year extension of the Board’s sunset date to January 1, 2022.

Establishes criteria a pharmacy must meet to identify and ensure that a person is assigned to assist the pharmacist when the pharmacist is otherwise working alone.



CONTROLLED SUBSTANCES:

New laws in effect as of 1/1/2021
Security Prescription Form Requirement
  • CA state law requires 15 elements to appear on the California Security Prescription Forms.
  • Requires California Security Prescription Forms forms to be produced by printers licensed by the California Security Prescription Printers Program.
  • Valid controlled substances prescription forms will contain a 12 character serial number and corresponding barcode compliance with the requirements outlined in AB 149.

Controlled Substances Reporting Requirements
  • The dispensing of controlled substances must be reported to the Controlled Substance Utilization Review and Evaluation System (CURES) no later than one working day after the medication is released to the patient or patient's representative.
  • Requires reporting the dispensing of Schedule V drugs, in addition to Schedules II, III, and IV.
  • This requirement applies and pharmacists and prescribers who dispense controlled substances.
URAC Unveils AccreditNet 3.0

The newly released AccreditNet 3.0 makes the desktop submission process more streamlined and easier to use. However, you will still need to document the specific citations (such as page number and paragraph reference). If you had submitted the application before February 26, 2021, and are currently in the application, you will continue to use AccreditNet 2.0.
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