Handle With Care: Dispensing Controlled Substances in the Pharmacy
Drug Topics
JULY 24, 2023
Filling a prescription for a controlled substance requires more oversight than the average prescription.
Controlled Substances Related Topics 
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The 2023 Controlled Substance Assessment Quiz
OctariusRx
FEBRUARY 20, 2023
The 2023 controlled substance assessment quiz is about to be released! This is our first annual competency assessment focused on controlled substances and regulatory compliance. The quiz focuses on some of the basic elements managing controlled substances. How are you assessing your staff?
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DEA’s Proposed Rules on Controlled Substances Prescribing via Telemedicine and Their Uncertain Impact on the Pharmacy Community
Pharmacy Times
APRIL 28, 2023
Proposed rules would permit a telehealth provider to prescribe only up to a 30-day supply of a Schedule III-V non-narcotic controlled substance or buprenorphine through telehealth without the patient first being evaluated in person by a provider.
The DEA is changing the process for reporting loss of controlled substances
OctariusRx
JULY 20, 2023
The DEA is changing the process for reporting loss of controlled substances. Effective July 24, 2023, the process for reporting lost controlled substances will be fully electronic. The post The DEA is changing the process for reporting loss of controlled substances appeared first on OctariusRX.
Electronic Controlled Substance RXs: Signed, Sealed, Delivered But Can’t be Filled
The FDA Law Blog
AUGUST 9, 2023
Houck — If a patient presents a paper prescription for a controlled substance to a pharmacy and the pharmacy cannot fill it, the patient can take that prescription to another pharmacy. Transfer of Electronic Prescriptions for Schedule II-V Controlled Substances Between Pharmacies for Initial Filling, 88 Fed. By Larry K.
Artificial Intelligence Is Revolutionizing Controlled Substance Diversion Detection
Pharmacy Times
SEPTEMBER 14, 2023
AI is able to quickly analyze, identify, and route data for investigation.
How to Leverage the Revised ASHP Guidelines to Prevent the Diversion of Controlled Substances at Hospitals
Pharmacy Times
DECEMBER 21, 2022
A controlled substances diversion prevention program (CSDPP) that aligns with the revised ASHP guidelines is critical to ensure patients are protected from occurrences of drug diversion.
How AI Can Improve Controlled Substance Security
Drug Topics
AUGUST 17, 2023
Each year, drug diversion is estimated to cost the US health care system an estimated $70 billion. Outside of these costs, drug diversion poses a significant risk to patient safety and patient’s communities.
Join Us for an HPM Webinar: Recent Hospital Controlled Substance Diversion Cases — Cautionary Tales; Tuesday, October 3, 2023: 12:00-12:45
The FDA Law Blog
SEPTEMBER 12, 2023
More than 40 registrants — primarily hospitals and pharmacies — have paid significant civil penalties of up to $5,000,000 to settle allegations they failed to report controlled substance thefts or significant losses to the Drug Enforcement Administration (DEA). The risks to hospitals and pharmacies are multi-faceted and growing.
DEA Reaffirms Synthetic THC Compounds Are Schedule I Controlled Substances
The FDA Law Blog
FEBRUARY 28, 2023
Houck — The Drug Enforcement Administration’s (“DEA’s”) February 13th determination that THC acetate ester (“THCO”) is a schedule I controlled substance under the federal Controlled Substances Act (“CSA”) has received a good amount of attention in the cannabis press. By Larry K. 51639, 51641 (Aug.
Controlled Substance Inventory Regulations
indispensable health
SEPTEMBER 7, 2021
DEA Regulations For Controlled Substances Within Healthcare Settings The U.S. to complete a biennial controlled substance inventory. to complete a biennial controlled substance inventory. The Pharmacist-In-Charge, Or Designee, Is Responsible For Completing An Inventory On Hand For ALL Controlled Substances.
STAT+: Telehealth companies that prescribed controlled substances during the pandemic brace for business to change
STAT
NOVEMBER 11, 2022
Health tech companies that have taken advantage of the possibility to prescribe controlled substances online during the pandemic may soon find their businesses — and their ability to care for patients — in jeopardy.
The Power of an End-to-End Controlled Substance Management Program
Omnicell
SEPTEMBER 5, 2022
The opioid crisis is not just a national issue, it’s also one of healthcare’s biggest challenges, making the security and accountability of controlled substances a priority for healthcare institutions. Adopting technology solutions to support controlled substance management.
Omnicell and Fresenius Kabi Join Forces to Improve Controlled Substance Management
Omnicell
JANUARY 10, 2023
Tara Plappert Product Marketing Manager Hospitals and clinics face a significant challenge when dealing with controlled substances. The Controlled Substance Dispenser dispenses one dose at a time, ensuring security, and minimizing the need for nurse countbacks. And according to the 2019 Drug Diversion Digest , 47.2
Prescribing Controlled Substances Goes Electronic
Pharmacy Times
SEPTEMBER 22, 2022
Eliminating paper prescriptions allows for greater legibility, security, trackability for pharmacists, providers.
Controlled Substances Prescribing Goes Electronic
Pharmacy Times
OCTOBER 12, 2022
Eliminating paper prescriptions allows for greater legibility, security, trackability for pharmacists and providers.
Telemedicine and the Prescribing of Controlled Substances After the End of The Covid-19 Pandemic Emergency: DEA Announces Two Significant Proposed Rules: Read the Summary Below, But Learn All the Details and More at HPM’s Webinar on March 23, 2023 (Details Forthcoming….)
The FDA Law Blog
FEBRUARY 27, 2023
Palmer — The 2008 Ryan Haight Online Pharmacy Consumer Protection Act placed strict limits on online prescribing or the use of telemedicine encounters to prescribe controlled substances. DEA’s proposed rule when finalized would authorize telemedicine pursuant to the Controlled Substances Act, 21 U.S.C. § By Karla L.
Court Addresses Liability in Dispensing Controlled Substances
Pharmacy Times
SEPTEMBER 28, 2022
Lawsuit asserts physician, pharmacist negligence in patient’s fatal overdose after she received alprazolam, oxycodone, oxymorphone.
Telehealth patients are scrambling for in-person care amid crackdown on online controlled substances
STAT
JANUARY 17, 2023
Catherine was getting nervous about her ADHD prescription. In 2022, the 29-year-old New Yorker had started using Done, a direct-to-consumer telehealth company that treats attention deficit hyperactivity disorder.
A Long Time Coming: DEA Regs Finally Authorize Schedule II Prescription Partial Fills
The FDA Law Blog
JULY 31, 2023
CARA amended the Controlled Substances Act (“CSA”) to enable physicians or patients to request pharmacists to partially fill prescriptions for schedule II substances including opioids and to allow remaining quantities to be filled up to 30 days after issuance of the prescription (up to 72 hours for emergency oral prescriptions).
How to help patients taking controlled medications
The Checkup by Singlecare
FEBRUARY 9, 2023
The law states that a pharmacist must only fill a prescription for a controlled substance when it is issued for a legit medical reason by a legitimate practitioner acting within the usual scope of their professional practice. The DEA defines a controlled substance as a drug or chemical known to be addictive or habit-forming.
Is your facility DEA compliant?
OctariusRx
JUNE 26, 2023
What would your facility do without a controlled substance license? As we all know, diversion of controlled substances has been on the rise. As we all know, diversion of controlled substances has been on the rise. We are in the business of making sure our patients are always safe when in our care.
The Most Important Audit in Pharmacy
indispensable health
MARCH 22, 2023
Our ManageRx team thinks the single most important audit is the Controlled Substance Invoice Audit. Why is the Controlled Substance Invoice Audit so important? It is critical to stop drug diversion in your pharmacy, surgery center, or any location using controlled drugs. before anyone notes it arrived. .
DEA Proposes Additions to Longstanding Precursor Chemical Special Surveillance List
The FDA Law Blog
JUNE 26, 2023
Houck — The Drug Enforcement Administration (“DEA”) has designated precursor chemicals, including 4-piperidone just last month, used in the illicit manufacture of controlled substances as List I and II chemicals over the years as “laboratory supplies,” but has never revised or updated its Special Surveillance List. 21 U.S.C. §
Pharmacies Selling PSE: Remember to Train Employees and Self-Certify
The FDA Law Blog
AUGUST 21, 2023
Attorney’s Office for the Western District of Texas announced that People’s Rx, a local chain operating five retail pharmacies and a compounding laboratory in the Austin area, agreed to pay $200,000 to settle allegations that it violated the Controlled Substances Act (“CSA”). 16, 2023 ( DOJ Press Release ).
Another Mystery Solved: DEA Issues a Final Decision Revoking Morris & Dickson’s Registration: Or Has It?
The FDA Law Blog
MAY 31, 2023
On May 24, 2019, Morris & Dickson paid a $22 million civil penalty related to the failure to report suspicious orders and ignoring certain red flags in the distribution of controlled substances. While this decision was pending, Morris & Dickson remained an authorized DEA registrant to continue to handle controlled substances.
Join Us for an HP&M Webinar – Demystifying DEA Inspections: Accountability Audits, Mirror Reviews and Mock Inspections (Wednesday, May 24: 12:00-12:45)
The FDA Law Blog
MAY 3, 2023
Accounting for controlled substances, maintaining complete and accurate records/reports and employing effective, compliant security do not alone guarantee a successful Drug Enforcement Administration (“DEA”) inspection. Registrants are far from powerless when DEA investigators inspect their controlled substance operations.
Retail Inventory Services Settle for Employee Thefts from Pharmacies
The FDA Law Blog
NOVEMBER 10, 2022
Attorney’s press release observes, it is a stark reminder that registrants are “ultimately responsible for supervising all personnel on the premises and preventing the diversion of controlled substances.” Company Pays $158,760 to Resolve Claims Related to Controlled Substance Thefts From Pharmacies During Inventory, U.S.
President Biden Gives the Green Light for Significant Marijuana Reform
The FDA Law Blog
OCTOBER 9, 2022
We also note there are states where marijuana remains the equivalent of a schedule I controlled substance. Separate and apart from the loosening of marijuana restrictions by these states, marijuana remains a schedule I controlled substance under federal law.
DEA To Host Supply Chain Conference
The FDA Law Blog
MARCH 30, 2023
Houck — Perhaps you obtain controlled substance quotas or submit ARCOS reports? DEA’s Diversion Control Division is hosting a Supply Chain Conference for registered manufacturers, distributors, importers and exporters on controlled substance and listed chemical requirements in Houston on May 2-4, 2023. By Larry K.
May 11, 2023: The End of the COVID-19 Pandemic Emergency’s DEA Telemedicine Exemption? “Not So Fast,” Say DEA and SAMHSA
The FDA Law Blog
MAY 10, 2023
Palmer — We blogged earlier this week here that DEA is reconsidering its proposed rules for telemedicine prescribing of controlled substances and buprenorphine. part 1306 (which include DEA’s general requirements for prescribing controlled substances); 88 Fed. By Karla L. 1307.41and 42 C.F.R. at 30,039 (emphasis added).
STAT+: California wants to revoke a CVS mail-order license for illegally filling opioid and ADHD prescriptions
STAT
DECEMBER 21, 2022
California authorities are seeking to revoke a license held by a CVS Health mail-order pharmacy unit for violating several state laws that govern shipments of various controlled substances — including prescription painkillers and ADHD medicines — directly to patients.
Mallinckrodt receives FDA nod for generic Vyvanse
Drug Store News
SEPTEMBER 1, 2023
Lisdexamfetamine Dimesylate capsules are a federally controlled substance used to treat Attention-Deficit/Hyperactivity Disorder and other indications.
DEA will delay telemedicine restrictions for buprenorphine, Adderall, and other drugs
STAT
MAY 3, 2023
The DEA announced Wednesday that it was temporarily extending its Covid-era emergency telehealth policies, allowing doctors continued leniency in how they prescribe some controlled substances. Read the rest…
Gabapentin Presents High Potential for Misuse
Pharmacy Times
NOVEMBER 24, 2022
Although the anticonvulsant is not considered a controlled substance, some state legislation focuses on monitoring the use of or reclassifying it.
Independent Pharmacy Compliance Controlled Drug Recordkeeping
DiversifyRx
AUGUST 25, 2023
Ensure you are with C2 Keep’s innovative controlled drug recordkeeping solution. Are you 100% sure you are performing all requirements to maintain compliance with the Controlled Substance Act (CSA)? Unfortunately, your staff is the #1 most likely culprit for theft or diversion of controlled drugs.
Opinion: Breakthrough Therapies Act: Good idea, wrong solution
STAT
DECEMBER 2, 2022
as a way to expand access for therapeutic purposes to potentially beneficial but highly regulated Schedule I substances like psilocybin and LSD, has the right underlying idea but provides a solution that is wrong. The Breakthrough Therapies Act , recently proposed by Senators Rand Paul (R-Ky.) and Cory Booker (D-N.J.)
HHS’ Recommendation to Reschedule Cannabis to Schedule III Raises Questions
The FDA Law Blog
SEPTEMBER 5, 2023
Houck — Scheduling Criteria Under the Controlled Substances Act (“CSA”) Schedule I: • High potential for abuse; • No currently accepted medical use in treatment in the U.S.; Schedule III: • Potential for abuse less than drugs or substances in schedules I and II; • Currently accepted medical use in treatment in the U.S.;
REMINDER: HP&M’s Webinar “Demystifying DEA Inspections: Accountability Audits, Mirror Reviews and Mock Inspections”
The FDA Law Blog
MAY 22, 2023
Accounting for controlled substances, maintaining complete and accurate records/reports and employing effective, compliant security do not alone guarantee a successful Drug Enforcement Administration (“DEA”) inspection. Registrants are far from powerless when DEA investigators inspect their controlled substance operations.
DEA Designates 4-Piperidone, Used in Illicit Manufacture of Fentanyl, A List I Chemical
The FDA Law Blog
APRIL 18, 2023
Houck — In addition to regulating drugs of abuse, the federal Controlled Substances Act (“CSA”) controls the manufacture and distribution of chemicals used in the illicit manufacture of controlled substances. By Larry K.
NACDS urges action to curb prescription drug misuse, abuse
Drug Store News
SEPTEMBER 30, 2022
Comments to the Centers for Medicare & Medicaid Services call for enforcement of electronic prescribing of controlled substances requirements no later than Jan.
TO BE CONTINUED (!?): DEA Announces It is Issuing a “Temporary Rule” to Address Telemedicine Flexibilities After the End of the COVID-19 Pandemic Emergency
The FDA Law Blog
MAY 7, 2023
As a reminder, back in February 2023, HPM blogged about DEA’s two proposed rules for prescribing controlled substances generally, and for buprenorphine use in opioid treatment. HPM also conducted a 90-minute webinar addressing the “End of the COVID-19 Emergency and the Ryan Haight Act: Telemedicine and Next Steps.”
How to prevent drug diversion
OctariusRx
FEBRUARY 6, 2023
The topic of properly handling controlled substances is always at the forefront of any discussion on compliance, but it extends far beyond just a paper trail. million dollars for violating provisions of the controlled substances act. Have a complete record of all movement of controlled substances within your facility.
Are Disparate Solutions Causing Visibility Gaps in Your Pharmacy Operation?
Omnicell
SEPTEMBER 5, 2022
One area where interoperability specifically helps is the management of controlled substances. When it comes to managing diversion, interoperability supports a tightened chain of custody across the controlled substance journey. That’s time gained to now spend on direct patient care.
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