The Board of Pharmacy published emergency regulations to make permanent 12 AAC 52.110 related to emergency licensure to practice as a pharmacist, pharmacy intern, or pharmacy technician. The emergency rule is effective retroactively to November 19. For more information, please see the March 15, 2021, filing notice which can be found here.
For more information, contact NACDS’ Sandra Guckian at 703-774-4801.
Effective July 1, 2021, the Board of Pharmacy will adopt amended regulations to consolidate the renewal license types into two categories: (1) a premises or facility license, and (2) a license issued to an individual, other than a pharmacist or an advanced practice pharmacist. This regulatory action amends and repeals regulations under 16 CCR 1702, 1702.1, 1702.2, and 1702.5 to consolidate standards for various board license types. The rule also requires disclosure of all continuing education requirements to renew a pharmacist or advanced pharmacist license as required by section 1732.5.
Also in California, the Board of Pharmacy readopts regulations originally adopted in emergency action 2020 – 0420 – 02E relating to the independent initiation and furnishing of HIV pre-exposure and post-exposure prophylaxis to patients as authorized by Statutes 2019, chapter 532 (SB 159). The rule is effective February 25 and expires August 24, 2021.
Also in California, NACDS and the California Retailers Association (CRA) submitted a joint letter to the California Senate Business, Professions & Economic Development Committee in opposition of SB 362 which would prohibit community pharmacies from utilizing metrics to evaluate the performance of employees. NACDS and CRA commented that while SB 362 is well-intentioned, it contains ambiguous and onerous requirements that are impossible for pharmacies to meet and maya ultimately threaten access to pharmacy services and jeopardize patient safety.
Also in California, NACDS and the California Retailers Association (CRA) submitted a joint letter to the California Senate Business, Professions & Economic Development Committee supporting AB 671, which will require the Department of Health Care Services (DHCS) to provide disease management or similar payment to DHCS contracted pharmacies dispensing specialty drugs to Medi-Cal beneficiaries.
Also in California, the Department of Health Care Services issued the Medical Rx Pharmacy Provider and Prescriber Readiness Survey to survey pharmacies on their current process to conducting business for Medi-Cal pharmacy services. The data in the survey will be held confidential and the results will be used by the Education & Outreach team to design training offerings for Medi-Cal Rx to prepare providers for the upcoming Medi-CAl Rx Transition.
Also in California, the Department of Justice, Office of the Attorney General announced the Office of Administrative Law’s (OAL) approval of new rules to strengthen the language of the California Consumer Privacy Act (CCPA) regulations approved by OAL in August 2020, including protecting consumers from unlawful business practices that may be deceptive or misleading.
For more information, contact NACDS’ Sandra Guckian at 703-774-4801.
The Department of Business and Professional Regulation issued a notice to announce its intentions to amend regulations under FAC 61N-1 regarding drug and device labeling requirements to make technical revisions to conform to statutes. The Department will be accepting comments but no due date has been specified.
Also in Florida, the Department of Health issued an emergency rule to adopt regulations under FAC 64DER21-4 to require all health care practitioners and other enrolled COVID-19 vaccine providers to report to the online immunization information system within 24 hours the administration of any COVID-19 vaccine with an emergency use authorization from the FDA. The rule replaces a December 15 rule on the same topic. The rule is effective March 15 and expires June 13, 2021.
Lastly, in Florida, the Department of Health issued an emergency rule to adopt regulations under FAC 64DER21-5 to authorize redistribution of the COVID vaccine between vaccine providers within the state. The rule requires providers to receive approval from the Florida Vaccines for Children and Adults Program and requires tracking of vaccine redistribution between enrolled providers. The rule is a readoption of a December 21 emergency rule. The rule is effective March 17 and expires June 15, 2021.
For more information, contact NACDS’ Leigh Knotts at 803-243-7207.
The Board of Pharmacy issued guidance on a recent amendment to the federal PREP Act that added retired and inactive pharmacists and pharmacy interns and certain student pharmacists to the list of health care professionals authorized to administer COVID-19 vaccines. The PREP Act provides immunity from liability for covered persons.
For more information, contact NACDS’ Sandra Guckian at 703-774-4801.
Effective March 22, the Office of Pharmacy Services (OPS) will be updating the incentive fee for all FDA-approved COVID-19 vaccines administered by pharmacy providers. The new incentive fee will be $40 for the administration of each dose of the vaccine. The incentive fee will be the same regardless of the vaccine and the number of doses required for the vaccination. Payment for the ingredient cost should be $ 0.01. See Advisory 224 for more information.
For more information, contact NACDS’ Jill McCormack at 717-592-8977.
The Division of Medicaid published a final rule to amend regulations under Title 23, Part 224, Chapter 1, to provide for coverage of vaccine administration by pharmacists. The rule is effective April 1, 2021.
For more information, contact NACDS’ Leigh Knotts at 803-243-7207.
The North Carolina Medicaid Department issued a proposed rule to require Medicaid recipients to get a 90-day supply of non-controlled, maintenance medications and remove the requirement that Medicaid (or a managed care company after July 1, 2021) would have to pay NADAC or the State MAC Price for the prescription. More details can be found at the above link on page 8. Comments can be submitted here and are due April 12, 2021.
For more information, contact NACDS’ Leigh Knotts at 803-243-7207.
Outpatient pharmacies in Ohio must now store all schedule II controlled substance dangerous drugs in a “securely locked, substantially constructed cabinet or safe,” which must remain locked and secured when not in use. Ohio Admin. Code 4729:5-5-23(A)(5). Schedule II substances can no longer be dispersed among a pharmacy’s stock of dangerous drugs. Pharmacies may store schedule III through V controlled substance dangerous drugs with schedule II controlled substance dangerous drugs in a safe or cabinet or continue to disperse them among non-controlled substances. For more detail see page 45 of the updated Inspection Guide. Though it was originally effective December 1, 2020, the Board of Pharmacy delayed implementation of this new requirement until March 31, 2021, because of COVID-19.
For more information, contact NACDS’ Jill McCormack at 717-592-8977.
NACDS has learned that the PALS application process for the Authorization to Administer Injectables for Pharmacy Interns has been released. Interns should log into or create a PALS account and select Board of Pharmacy then “Authorization to Administer Injectables for Pharmacy Interns.” The Board is asking that pharmacy interns who previously submitted an intent to immunize also now register through this process.
For more information, contact NACDS’ Jill McCormack at 717-592-8977.