July 2023 - Newsletter
Included in this newsletter
- DEA Finalizes Rule on Reporting Theft and Significant Loss of Controlled Substances
- DSCSA/Track & Trace
- ACHC Standards – Non-Sterile Compounding
- Podcasts - DiversifyRx Pharmacy Compliance Series
- Come See Us
- Updated and New Forms
- Updated and New Policies & Procedures
- Compliance Corner
- Meet Our Staff- Jenny Schell
DEA Finalizes Rule on Reporting Theft and Significant Loss of Controlled Substances
The Drug Enforcement Agency (DEA) recently published a final rule, effective July 24, 2023, which amends the regulations regarding DEA Form 106, used by registrants to formally report thefts or significant losses of controlled substances. The final rule requires that all DEA Form 106s be submitted electronically. DEA will allow registrants 45 days from discovery of the theft or significant loss to submit the form, up from the DEA’s original proposal of 15 days.
Paper DEA 106’s will not be accepted after 07/24/2023.
All unused paper DEA 222 forms are to be returned to the DEA Regional Office.
- Owner of Northeast Philadelphia Pharmacy Charged with Conspiracy to Distribute Oxycodone and Fraud | USAO-EDPA | Department of Justice
DSCSA/Track & Trace
The Drug Supply Chain Security Act (DSCSA) is coming on November 27, 2023. This is too big for most pharmacies to try to do alone and remain in compliance. There are two companies whose software works with all pharmacy systems.
Look out for New podcast dropping soon on DSCSA compliance!
ACHC Standards - Non-Sterile Compounding
The Accreditation Commission for Health Care (ACHC) released their non-sterile compounding standards on July 12, 2023 during their USP 795 Workshop. A couple of items to prepare for:
- Accreditation surveys will encompass all employees being interviewed.
- Annual competency assessments are required.
- DSCSA requirements must be met for compound products.
- Extending Beyond-Use-Dating (BUD) – If the pharmacy decides to “Extend the BUD Date”, the pharmacy must have a Certificate of Analysis for the compound product. Any compounding pharmacy that wishes to have the capability to extend a BUD, please notify your Project Manager immediately.
- Individual states are issuing their own guidance, i.e., California and Texas. Both in-state and out-of-state compounding pharmacies must comply with these requirements, but ACHC will not review during accreditation surveys.
- Pharmacies must demonstrate a recall of compounds.
- Personal Protective Equipment (PPE) must be used by all employees based on the Safety Data Sheets (SDS).
- Respirators are to be properly fitted to the employee. Sharing is not permitted.
- A medical notification is to be signed by the employee if they will compound drugs that can harm reproductive organs.
- Updated Policies and Procedures will be uploaded to the Compounding program on the Compliance Portal® as they are completed. There are approximately sixty-two new and revised policies.
Podcasts - DiversifyRx Pharmacy Compliance Series
Jeff Hedges and Lisa Faast of DiversifyRx have teamed up to host a Pharmacy Compliance Series through the DiversifyRx platforms. Listen to some of their conversations regarding current rules and regs discussions
- Billing Process Medicare & DME
- Pharmacy Compliance Audits
- DEA Controlled Drugs
- Hazardous Drug Compliance
Come See Us
- Dallas, TX, Aug 4 – 5, 2023
- Jeff is presenting on both Stage
- Stage 1(Pharmacists) and Stage 2 (Technicians)
NCPA’s Ownership Workshop
- Orlando, FL October 12-13, 2023
New and Updated Forms
- DME Adverse Event Report
- OptumRx Part D on-site Audit Checklist
New and Updated Policies and Procedures
- Pharmacy & Compounding
- There will be large updated to dozens of Policies and Support Documents pertaining to USP <795> and USP <800>. We are holding them at this time, but will release them soon.
When HIPAA was signed in 1996 only about 1% of the US population had cell phones or the internet, so the notion of sending text messages, emails, and even having apps for medical records wasn’t even a consideration. There are massive regulatory changes coming to HIPAA to bring it up to speed with technology and app advancements. We’re currently seeing a slow drip of information but the massive release has not occurred yet. One recommendation, if you are not utilizing messaging apps that are encrypted- start now! Not only is it a good practice to help protect patient PHI, it will soon be required. Services such as Spruce, OhMD, or Weave to name a few.
Keep in mind sending SMS messages with PHI is NOT secure, even if you delete the messages from your device they are never really gone and could be accessed from storage servers.
Meet our Staff- Jenny Schell
She’s a mom, a proud Penn State Alumni, and your go-to woman for understanding how compliance can fit into your pharmacy.
For over 13 years, this perky, caring, and wise compliance chick has been helping independent pharmacists find solutions to simplifying compliance and answering questions ranging from opening/buying a pharmacy to questions on how to get Medicare numbers, moving into exemptions, and even how to add extra services to be more profitable.
She’s a bubbly, people person who loves to be around lots of people, whether it’s a function for church, a party, or hosting a bunch of people for dinner.
Between running a side business with her husband and chasing three kids around (Clayton 10, Maggie 7, and Jameson 4), she sustains herself on Chick-Fil-A and a lot of caffeine.
Jenny has been part of the R.J. Hedges & Associates team since 2010, working in Sales & Marketing. She is generally one of the 1st people clients speak with; her ability to talk to anyone and knowledge of many services and companies that also support pharmacies helps her make recommendations. We lovingly say Jenny is not a Salesperson; she is a Shares-person since she always makes recommendations and connections.
In her free time (which never happens because she is eternally optimistic about how much time she really doesn’t have), she can be found helping her husband with their custom butcher shop, canning fruits, veggies, and meat or running the kids to different activities.