While California amended its regulations on pharmacy closure earlier this year, many pharmacy owners are still confused regarding the requirements when they are selling files, filing for bankruptcy, or simply closing their doors. So what does California require?
Patient notices:
If the pharmacy closes (sells its files or goes out of business), it must
Business and Professions Code (BPC) § 4113.1 established requirements for a community pharmacy to report medication errors to an entity approved by the California State Board of Pharmacy (“Board”) within 14 days of discovery. The Board approved Institute for Safe Medication Practices (“ISMP”) as the entity to receive and review medication error reports under BPC
As always, California is at the forefront of inventing new requirements for enforcing compliance with pharmacy laws. This time, the new requirement pertains to Pharmacists-in-Charge (PICs).
Effective April 1, 2025, all proposed PICs are required to complete a training course available on the California State Board of Pharmacy’s website, within two years prior to the
Starting January 1, 2023, California pharmacies will be required to have a new written policy and procedure addressing controlled substances inventory reconciliations. The amended California Code of Regulations 1715.65 now requires that pharmacies perform inventory reconciliation report:
– on all federal controlled substances;
– for federal Schedule II drugs at least once every three months;
Back in 2021, the Secretary of the federal Department of Health and Human Services authorized licensed pharmacists to independently order and administer any COVID-19 therapeutic, subject to certain conditions ( under the Ninth Amendment to Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19).
Recently – on July 6, 2022
If you work in a pharmacy in California, I am sure you are aware of the new e-prescribing requirement that took effect on January 1, 2022. Because I’ve been receiving many calls from pharmacists regarding this new law, I decided to create this post and clarify a few points.
In a nutshell, the new law
Automatic refills is a landmine. Some states prohibit them outright. Medicare requires patient consent before each delivery. Most PBMs also place some conditions on auto-refills, such as obtaining authorization from the patient for each refill (to prevent fraud, waste and abuse and to ensure that patients receive only medications that they have requested). PBM manuals
In March 2020, the California State Board of Pharmacy issued a “Remote Processing” waiver, which is still in effect today (with some modifications). For the purpose of the waiver – as the Board explained – “remote processing” means the entering of an order or prescription into a computer from outside of the pharmacy or hospital
This year, the California State Board of Pharmacy (“Board”) adopted a new regulation applicable to pharmacies where pharmacists perform non-professional activities because they work alone. The regulation – Title 16, California Code of Regulations, Section 1714 – establishes criteria a pharmacy must meet to identify and ensure that a person is assigned to assist the
On October 1, 2020, the California State Board of Pharmacy amended Title 16, Cal. Code of Regulations, Section 1707.2. The section explains the requirements for providing patient consultations when medications are delivered or mailed. Pharmacies that deliver or mail must provide their patients with a written notice of the hours of availability for consultation and