PharmacyRequirements for Prescriptions
Section § 4070
This law states that pharmacists must write down oral or electronic prescriptions promptly, except for certain information easily accessible at the pharmacy. Pharmacies receiving electronic prescriptions don't need to print them if they can produce a hard copy report of dispensing details for three years. This doesn't apply to controlled substances unless exceptions are met. Electronic records must remain unaltered and any corrections require a pharmacist's approval. Prescriptions should go to the pharmacy chosen by the patient, except in certain hospital settings.
Section § 4071
This law allows doctors to have their assistants send prescriptions to pharmacies either by phone or electronically. However, the pharmacy needs to check that the person sending the prescription is really allowed to do so and write down that person's name. Importantly, this rule does not apply to certain highly controlled drugs, known as Schedule II substances.
Section § 4071.1
This law allows prescribers, their authorized agents, or pharmacists to enter prescriptions or orders into a pharmacy or hospital computer from any location, with permission. An authorized agent must be licensed or registered appropriately. The law also states that hospital personnel can still enter medication orders as usual. Importantly, any prescription entered electronically requires a pharmacist's approval before it can be dispensed if it involves a dangerous drug or device. Additionally, California-licensed pharmacists can verify medication orders remotely for health facilities, and these facilities must keep records of these verifications in compliance with specific requirements.
Section § 4072
This law lets certain medical professionals who work in health care facilities, like nurses and pharmacists, send prescriptions electronically or orally if they're authorized by regulations. However, it doesn't apply to Schedule II drugs, which are more strictly controlled. The law also acknowledges the State Department of Public Health's role in overseeing drug orders in these facilities.
Section § 4073
A pharmacist can substitute a prescribed brand-name drug with a generic version that has the same active ingredients and strength, as long as it costs the patient less. However, if the doctor specifically states "Do not substitute" on the prescription, either in writing or electronically, the pharmacist must dispense the exact brand prescribed. When a substitution is made, the patient must be informed, and the new drug's name should appear on the label unless the doctor specifies otherwise. The pharmacist is responsible for the choice of drug, not the prescriber, and the rule applies even if the prescription is under government assistance programs.
Section § 4073.5
This law allows pharmacists in California to substitute a prescribed biological medicine with an interchangeable one, as long as it's been approved for interchangeability. However, if the doctor specifically writes "Do not substitute" on the prescription, the pharmacist must dispense exactly what was prescribed. After giving the medication, pharmacists have five days to update the prescribing doctor about what was dispensed through electronic systems. If electronic systems aren't available, other communication methods can be used unless certain conditions apply, like no approved interchangeables exist or it's a refill with no change in medication. The pharmacist must ensure the substituted product costs the same or less than the original. The pharmacist is responsible for their choice of substitution, not the prescribing doctor. Patients should be informed about any substitutions, and a current list of interchangeable biological products can be accessed via a maintained website. This law also doesn't affect insurance companies' rights to require prior approvals or other controls on medication coverage.
Section § 4074
This law requires pharmacists to inform patients, either orally or in writing, about harmful effects of prescribed drugs, specifically if they can be dangerous when combined with alcohol or if they impair driving. Starting July 1, 2014, pharmacists must also label medications that might impair someone’s ability to drive or operate a vehicle. Some drugs are exempt from these requirements, particularly those given during hospital treatment or emergencies, unless specified otherwise. Hospitals must ensure patients are informed about their medications at discharge, including how to use and store them safely. This information can be provided by a pharmacist or nurse and doesn't have to be exclusively given by a pharmacist.
Section § 4075
This law states that prescriptions for controlled substances, whether given orally or electronically, cannot be provided to anyone who cannot prove their identity. Also, the board can set rules to prevent unauthorized people from getting these prescriptions.
Section § 4076
This law requires pharmacists to ensure that prescription drugs are dispensed in containers that meet legal requirements and are properly labeled. The labels must include specific details like the drug's name, directions for use, patient's name, prescriber's name, issue date, pharmacy details, drug strength and quantity, expiration date, and description of the medication. Exceptions exist for unit dose systems in health facilities and for drugs used under expedited partner therapy (EPT) or for medication abortion, where certain labeling rules can be relaxed. Pharmacists have the discretion to exclude patient or prescriber information under these circumstances but must keep a log and ensure confidentiality. They should also use professional judgment to provide clear directions and offer additional consultation for EPT.
Section § 4076.5
This law requires that all prescription drugs dispensed in California have a standardized, patient-centered label by January 1, 2011. The California board must develop these labeling regulations by considering factors like medical literacy, clear directions, appropriate font sizes, and the needs of people with limited English proficiency and seniors. Public meetings should be held for input from various groups. Some exemptions are allowed, such as for medications administered by healthcare professionals in health facilities and for certain home infusion therapies, where patients get specialized education and follow-up care.
Section § 4076.6
This law requires pharmacies to offer translated medication instructions when a patient or their representative asks for them. These translations should be printed on the prescription bottle, label, or a separate document. English instructions must also appear, if possible. Pharmacies can use official translations provided by a regulatory board or create their own. They must ensure the English instructions are correct, but they aren't required to translate into languages not supported by the board. This doesn't apply to pet prescriptions from veterinarians.
Section § 4076.7
When a pharmacy or practitioner gives out a prescription drug containing an opioid for use outside of a hospital, they must include a clear warning label on the container. This label should say, “Caution: Opioid. Risk of overdose and addiction.”
Section § 4076.8
This law requires pharmacies to provide accessible prescription labels at no extra cost if a person identifies as blind, low-vision, or print disabled. These labels must be provided quickly and should last at least as long as the prescription does. They need to be suitable for the person's disability and language, following practices set by national health standards. If a prescription label can't fit on the container, a supplemental document must be given. This requirement doesn't apply to pharmacies in certain institutions, like prisons, but does apply when prescriptions are provided for use after release. Institutional pharmacies and prescription readers have specific definitions here, and the board will create regulations to enforce this section.
Section § 4077
This law mainly deals with how dangerous drugs must be labeled when they are given out in California. Typically, drugs must be dispensed in containers that have proper labels. However, doctors, dentists, and certain other professionals can give out drugs directly to their patients as long as they label the drugs correctly, even if they don't include a prescription number. Medical devices with specific warnings can bypass some labeling rules if they are given to patients in certain licensed care facilities. Additionally, any dimethyl sulfoxide (DMSO) given out must have a health warning, and DMSO packages must advise on safe handling and keeping it away from children.
Section § 4078
This law says you can't put false or misleading labels on prescriptions, and prescribers shouldn't ask for misleading labels either. However, there are exceptions. If false labeling is needed for FDA-approved research or is deemed necessary by the prescriber for the patient's treatment, it's allowed. When this happens, records describing the true drug information and the prescriber's instructions must be kept for three years.
Section § 4079
Pharmacies must tell customers if the price of a prescription drug is cheaper than what they'd pay through their health insurance. If a customer chooses to pay the lower price, the pharmacy should still process it through insurance as if the customer paid their normal out-of-pocket cost. This payment counts towards the customer’s deductible and out-of-pocket limits. Any contract terms that disagree with this rule are void. If any part of this law is found invalid, the rest still applies. Breaking these rules doesn't lead to penalties or criminal charges. The law started on January 1, 2020.