A Quarterly Newsletter of the State Board of Pharmacy
A reminder that the Insulin Affordability Program was created through the passage of HB21-1307 (Prescription Insulin Pricing and Access) and went into effect on Jan. 1, 2022. The law established two distinct Insulin Affordability Programs. Eligible individuals can receive a 12-month prescription for insulin for no more than a $50 copay for a 30-day supply and an emergency 30-day supply of insulin once per 12-month period for no more than a $35 copay. The form and more information on these programs are available here. Pharmacies should contact their insurance carrier and/or the manufacturer with any billing questions.
Buprenorphine X-Waiver Registration No Longer Needed
On December 29, 2022, with the signing of the Consolidated Appropriations Act of 2023, Congress eliminated the “DATA-Waiver Program.”
The MAT Act was included in the end-of-year omnibus spending bill and passed Congress at the end of December. The bill removes a federal barrier on pharmacists prescribing buprenorphine, known as the X-waiver.
The legislative package also includes several provisions addressing pharmaceutical supply issues.
All DEA registrants should be aware of the following:
A DATA-Waiver registration is no longer required to treat patients with buprenorphine for opioid use disorder.
Going forward, all prescriptions for buprenorphine only require a standard DEA registration number. The previously used DATA-Waiver registration numbers are no longer needed for any prescription.
There are no longer any limits or patient caps on the number of patients a prescriber may treat for opioid use disorder with buprenorphine.
The Act does not impact existing state laws or regulations that may be applicable.
Separately, the Act also introduced new training requirements for all prescribers. These requirements will not go into effect until June 21, 2023. The DEA and SAMHSA are actively working to provide further guidance and DEA will follow up with additional information on these requirements shortly. Importantly, these new requirements do not impact the changes related to elimination of
the DATA-Waiver Program described above.
For information regarding DEA’s Diversion Control Division, please visit https://www.DEAdiversion.usdoj.gov. Please contact the Diversion Control Division Policy Section at ODLP@dea.gov if you seek additional assistance regarding this or any other matter.
News from the Food and Drug Administration
Information Released Regarding Compounding Ibuprofen in Hospitals
The Food and Drug Administration (FDA) has issued guidance regarding compounding certain ibuprofen oral suspension products in outsourcing facilities for administration in hospitals and health systems under Section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
The United States is currently experiencing a surge in coronavirus disease 2019 (COVID-19), respiratory syncytial virus (RSV), and influenza. These viruses may produce fever in young children, and untreated high fever could potentially lead to serious or life-threatening situations in certain vulnerable populations. The FDA has received reports related to increased demand for pediatric fever-reducing medications, including ibuprofen oral suspension products.
Additionally, the FDA is aware of reports from hospitals and health systems that have experienced difficulties obtaining these medications to use for pediatric patients with fever and adults who are unable to swallow solid oral dosage forms (i.e. patients with feeding tubes) due to, for example, regional disparities in infection rates, distribution of resources, or other conditions that may evolve quickly during the winter months when the incidence of respiratory infections is expected to peak.
This immediately-in-effect guidance is limited to ibuprofen oral suspension products used in hospitals because hospitals treat patients with more acute needs and have better controls to assure appropriate dosing and administration than generally would be found in the household setting.
A list of questions and answers on compounded oral suspension medications for pain and fever is available on the FDA website.
The FDA issued warning letters to companies illegally selling products that claim to cure, treat, mitigate, or prevent human monkeypox (mpox) infection. Mpox is a rare disease that is caused by infection with mpox virus. This virus can spread to anyone through close, personal, often skin-to-skin contact. There are no FDA-approved treatments for mpox. These products, which are often sold online, have not been reviewed by the FDA or proven to be safe and effective to treat mpox or other diseases or conditions. Read More
In Other News
The National Association of State Boards of Pharmacy have alerted the Colorado State Board of Pharmacy of a new recall fraud attempt focusing on Oxycodone Hydrochloride.
Some pharmacies have received emails/faxes with a letter, which is being spoofed as being from a legitimate pharma distributor, indicating the following:
(Distributor) is updating all direct account Wholesalers, Distributors and pharmacies that have received the impacted NDC below. We are initiating a recall of lots distributed to date on a precautionary basis. This recall is being conducted at the Retail Level. Please note all lots are being recalled. Thank you.
While the specific product manufacturer of Oxycodone HCL is not expressly stated in the correspondence sent, the NDC Code indicates the product is assigned to a single package of 100 tablets. The manufacturer is Specgx Llc. No such manufacturer recall exists at this time.
It’s important to note that none of these illicit attempts, to date, have been successful. The law enforcement authorities investigating these incidents ask that all companies and industry associations make their employees/members aware of this new tactic.
If you receive any type of communication which references ANY type of a recall, document as much about the interaction as possible. That should be followed with a call to a known contact of your distributor partner to determine if the request is legitimate. If it isn’t, report the occurrence to the PCSC at cforsaith@hda.org or by calling 401-623-1344 as soon as reasonably possible.
All attempts, successful or not, need to be documented to further the overall investigation.
A recently published CDC study assessed the incidences of whooping cough among infants in the U.S., and the results provided additional evidence that Tdap vaccination during pregnancy helps protect newborns from contracting the disease during their first two months of life. Read More
dora_pharmacyboard@state.co.us