According to the most recent federal decision on the topic, state regulations of outsourcing facilities are not preempted by federal law. And therefore, facilities should comply with both.

The state-preemption challenge was brought by a federally-registered outsourcing facility against California on a ground that it denied its application under certain pharmacy-related regulations. Namely, a California

More and more states are mandating e-prescribing. Some states require e-prescribing only for CII controlled substances, some for all controlled substances, and some require e-scripts for all medications.

States with current e-Rx mandate laws are:

    • Connecticut (e-prescribing for controlled substances only, no penalties for non-compliance)
    • Maine (e-prescribing for controlled substances only, penalties provided)
    • Minnesota (all

Earlier this year, I posted an update that a uniquely serialized number attributable to a prescriber must appear on California prescription forms for controlled substances. The new requirement became effective on January 1, 2019. The Enforcement Committee, however, recommended to the California State Board of Pharmacy to allow for grandfathering time until June 1, 2019.

Starting January 1, 2019, a new security feature must appear on California prescription forms for controlled substances. The legislature amended Health & Safety Code § 11162.1 by adding the 15th security feature: a uniquely serialized number attributable to a prescriber.

Most prescribers still use their old prescription forms, which do not have a serialized number.

Walmart and RB Health started offering free access to Doctor-on-Demand to some of its customers. In a recent announcement, the parties emphasized their commitment to provide unprecedented access to low-cost high-quality healthcare. Customers who purchase Mucinex®, Delsym®, Airborne® or Digestive Advantage® at Walmart stores now receive a voucher for a no-cost telehealth medical consultation

The California Board of Pharmacy’s July 2018 issue of “The Script” highlights new regulations on inventory reconciliation of controlled substances. Because dispensing controlled substances is still the most frequently cited disciplinary offense, this post focuses and further explains some of the requirements. The regulation could be found in California Code of Regulations, title 16, Section

Many California pharmacies have questions regarding the newly enacted California’s prohibition on drug manufacturers’ coupons, co-pay cards, and other discounts. The prohibition became effective on January 1, 2018, and created confusion within the industry about when manufacturer’s assistance can be applied to medications dispensed.

To start, California’s AB265 attempts to curb the ever-rising drug costs

The Department of Justice (DOJ) announced that in 2017 it recovered more than $3.7 billion stemming from the enforcement of the False Claims Act. The healthcare industry accounted for most of it ($2.4 billion).

The largest portion of recoveries from the healthcare industry came from drug and medical device companies (more than $900 million). The

Pharmacy practice:

  • New compounding rules: While USP 800 does not go into effect until July 2018, the California State Board of Pharmacy imposed its own requirements for the handling and compounding of hazardous drugs. It did not adopt USP 800 in its entirety and enacted some unique provisions, for example requiring that:

  • all CPEC be

As a practical matter, pharmacists in California already provide written warnings on medications dispensed. Now California law expressly requires pharmacists to include written labels on prescription drug containers indicating that the drug may impair the ability to operate a vehicle or a vessel and that it poses a significant risk if consumed with alcohol. Failure