FDA Law Blog: Biosimilars

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).

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Controlled Substances Long-Term Care Facilities Dosage Communication 98

FDA Law Blog: Biosimilars

AUGUST 8, 2024

Comments ranged from single sentence declarations to lengthy, cogent treatises, expounding on whether to reschedule marijuana from schedule I to schedule III or another schedule under the federal Controlled Substances Act (“CSA”), to leave marijuana in schedule I, or to deschedule altogether. 21 U.S.C. § 812(c)(c)(10). 21 U.S.C. §

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Controlled Substances Dosage 57

FDA Law Blog: Biosimilars

JUNE 27, 2024

District Court for the District of Texas on Zarzamora Healthcare LLC for repeatedly dispensing opioids and other controlled substances “by filling prescriptions while ignoring red flags.” Last December we blogged on the $275,000 civil penalty imposed by the U.S. Gulf Med Pharmacy; Decision and Order, 86 Fed. 72,694, 72,703 (Dec.

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Controlled Substances Dosage Documentation 52

FDA Law Blog: Biosimilars

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.

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Controlled Substances 57

FDA Law Blog: Biosimilars

MARCH 12, 2023

When the public health emergency ends on May 11, 2023 , so do these exemptions. We will discuss the state of relevant laws prior to our new “COVID reality” and telemedicine issues during and post-pandemic, both with respect to the prescribing of controlled substances and non-controlled drugs.

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Controlled Substances 98

FDA Law Blog: Biosimilars

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. §

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Controlled Substances 51

FDA Law Blog: Biosimilars

OCTOBER 8, 2023

Palmer — On Friday, October 6, 2023, DEA announced a second extension of telemedicine flexibilities concerning the prescribing of controlled substances, which were originally set to expire after the end of the COVID-19 pandemic emergency. comments on the two proposed rules.

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Controlled Substances 62

FDA Law Blog: Biosimilars

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.

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Controlled Substances 40

FDA Law Blog: Biosimilars

MAY 7, 2023

Palmer — On May 3, 2023, DEA’s Administrator Anne Milgram issued a very brief and lightly publicized statement announcing that DEA intends to issue a “temporary rule” extending telemedicine flexibilities that existed during the COVID-19 Emergency Declaration, which Declaration is set to expire on May 11, 2023. By Karla L.

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Controlled Substances 52

FDA Law Blog: Biosimilars

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. Designation of 4-Piperidone as a List I Chemical, 88 Fed. a)(38) (Apr.

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Controlled Substances 57

FDA Law Blog: Biosimilars

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 ).

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Controlled Substances General Merchandise Stores Grocery Stores Compounding 52

FDA Law Blog: Biosimilars

JANUARY 18, 2024

Houck — In August 2023 the Food and Drug Administration (“FDA”) and Health and Human Services (“HHS”) recommended that the Drug Enforcement Administration (“DEA”) reschedule marijuana from schedule I under the federal Controlled Substances Act (“CSA”) to schedule III. By Larry K.

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Controlled Substances Chemotherapy Compounding Dosage 67

The Happy PharmD

OCTOBER 11, 2024

Despite its substantial revenue of $24 billion in 2023, Rite Aid faced a steady decline leading to its eventual bankruptcy filing. Allegations of improper handling of controlled substances and subsequent legal battles resulted in significant penalties and loss of trust from vendors and customers alike.

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Controlled Substances Compounding 52

FDA Law Blog: Biosimilars

APRIL 10, 2023

Houck — Drugs and substances classified within schedule I of the federal Controlled Substances Act (“CSA”) by definition have a high potential for abuse, no currently accepted medical use in treatment in the United States, and lack accepted safety for use under medical supervision. By Larry K. 21 U.S.C. §

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Controlled Substances 57

FDA Law Blog: Biosimilars

MARCH 27, 2023

Thank you to those who registered for and attended Hyman, Phelps & McNamara’s March 23, 2023 lunchtime webinar addressing the “End of the COVID-19 Emergency and the Ryan Haight Act: Telemedicine and Next Steps.” As promised during the 90-minute program, we provide our slides here, and a recording of the program, here (passcode.

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Controlled Substances 40

National Association of Boards of Pharmacy

DECEMBER 6, 2023

Furthermore, xylazine is also associated with physical dependence, withdrawal symptoms, and a general substance use disorder (SUD). While federal law does not classify the drug as a controlled substance (CS), some states have enacted laws or temporary orders to regulate its possession, distribution, and use.

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Controlled Substances Packaging 72

Pharmaceutical Business Review

SEPTEMBER 1, 2023

Lisdexamfetamine Dimesylate Capsules are a federally controlled substance (CII) intended for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) and other indications. Lisdexamfetamine Dimesylate achieved global net sales surpassing $3bn in Takeda’s fiscal year that concluded on 31 March 2023. Louis, Missouri.

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Controlled Substances 52

European Pharmaceutical Review

JUNE 26, 2023

For example, regarding psychedelics that are currently Schedule I controlled substances, the draft guidance noted that activities associated with investigations under an Investigational New Drug (IND) application must comply with applicable Drug Enforcement Administration regulatory requirements.

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Controlled Substances Drug Development 98

Board Vitals - Pharmacist

JANUARY 6, 2023

Updated as of January 6, 2023. Upon first renewal, requirements include one hour in HIV/AIDS, professional and medical ethics, Florida laws and rules, and controlled substances, as well as, two hours of domestic violence and medical errors prevention. One credit is required in prescribing controlled substances every other year.

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Controlled Substances Documentation 59

FDA Law Blog: Biosimilars

AUGUST 4, 2023

Houck — Anabolic steroids that include testosterone, methyltestosterone, nandrolone decanoate and oxandrolone are schedule III controlled substances with currently accepted medical uses in the U.S. Implementation of the Designer Anabolic Steroid Control Act of 2014 , 88 Fed. By Larry K. 50,036 (Aug.

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Controlled Substances Labelling 52

National Association of Boards of Pharmacy

JULY 12, 2023

During multiple pharmacy investigations, I discovered that pharmacists were diverting controlled substances for their personal use. This blog was adapted from an article that originally appeared in the May 2023 issue of Innovations. Is there an inspection experience that you found particularly interesting, egregious, or unusual?

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Pharmacy Technician Pharmacy Management Controlled Substances Communication 96

Integra X Files

FEBRUARY 20, 2023

Three years later, the Secretary announced that the PHE would be allowed to expire on May 11, 2023. The requirement for private health plans to provide vaccines for free expires with the end of the PHE, but the reimbursement for administering the vaccine in public programs extends through the end of 2023.

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Nursing Homes Vaccines Controlled Substances Hospitals 89

Pharmaceutical Technology

MARCH 30, 2023

The FDA’s proposed FY2024 Budget tops $7bn, to be shared between drug, food, and cosmetics tasks and overheads such as buildings; this is $372m higher than in FY 2023, a 10% increase. At present, the FDA can only force recalls for controlled substances and biologics, and relies on voluntary recalls by pharma companies for other drugs.

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Controlled Substances Labelling 59

Quality Matters

MAY 23, 2023

The challenges associated with online pharmacies are not just limited to the distribution of counterfeit medicines – they also include the potential to exacerbate addiction and substance abuse through the availability of controlled substances. kristine.gates… Tue, 05/23/2023 - 10:25 Supply Chain

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Online Pharmacies Controlled Substances Packaging Communication 52

FDA Law Blog: Biosimilars

JULY 1, 2024

The request for hearing follows a n October 2023 letter preceding the NPRM from six former Administrators and five former Directors of National Drug Policy. The C ontrolled S ubstances A ct (“CSA”) requires analysis of eight statutory factors for scheduling, rescheduling, or descheduling substances of abuse. 21 U.S.C. §

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Dosage Controlled Substances 52

National Association of Boards of Pharmacy

OCTOBER 13, 2022

In the latest round of Drug Enforcement Agency’s (DEA) enforcement action against counterfeit controlled substances (CS), popular apps such as Snapchat, Facebook Messenger, Instagram, and TikTok were involved in one-third of the 390 investigations. These investigations, which took place from May to September, seized a staggering 10.2

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Controlled Substances Communication 40

LifeProNow

MARCH 10, 2023

March 09, 2023: “The U.S. The request includes an increase of $372 million in budget authority — or 10% above the FY 2023 Enacted Level — and a $150 million increase in user fees. 1, 2023, through Sept. Food and Drug Administration announced it is requesting $7.2 The FY 2024 request, which covers the period from Oct.

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Labelling Packaging Controlled Substances 130

FDA Law Blog: Biosimilars

APRIL 13, 2023

The Drug Enforcement Administration (“DEA”) could voice a modern variation, “Bring out your meds,” as the agency and its law enforcement partners host local drop-off locations nationwide for safe disposal of unneeded medication on Saturday, April 22, 2023, from 10:00 a.m. to 2:00 p.m. local time.

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Controlled Substances 57

National Association of Boards of Pharmacy

SEPTEMBER 27, 2023

The major components that the team looks for during a site visit are: controlled substance security, temperature control, cleanliness, business continuity and disaster planning, and who the business is buying from and selling to.

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Sterile Compounds Controlled Substances Compounding Hospitals 59

FDA Law Blog: Biosimilars

APRIL 8, 2024

For example, DEA and FDA jointly acknowledged in an August 1, 2023 letter that there have been ongoing shortages of various stimulant medications (e.g., Finally, on October 3, 2023, DEA published an increase to the methylphenidate APQ. However, the White Paper does not acknowledge the role that DEA plays.

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Inpatient Hospitals Dosage Controlled Substances 57

FDA Law Blog: Biosimilars

OCTOBER 19, 2023

local time on Saturday, October 28, 2023. DEA is not a band, but along with its law enforcement partners, the agency will host thousands of local drop-off locations nationwide for clearing out and proper disposal of expired and unneeded medication from medicine cabinets between 10:00 am to 2:00 p.m.

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Controlled Substances 40

FDA Law Blog: Biosimilars

AUGUST 16, 2023

And before CooperSurgical, another 2021 Warning Letter was issued to AcelRx for the infamous “Tongue and Done” tagline used to promote a Schedule II controlled substance subject to a REMS program that requires a healthcare professional’s precise placement of the drug using a single-dose applicator into the patient’s sublingual space.

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Labelling Controlled Substances Communication 52

Proxsys Rx

JULY 5, 2023

Our next regulatory challenge was gaining approval from Cardinal CSMP (Controlled Substance Monitoring Program). By now, it was late March, 2023 — thirteen months into our Holyoke odyssey, but still three months before the pharmacy would open.

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Hospitals Inpatient Prescription Filling Controlled Substances 52

FDA Law Blog: Biosimilars

NOVEMBER 6, 2023

is pleased to announce it took top honors in two categories in the 2023 LMG Life Sciences Awards, which recognize the best life science practitioners and firms over the past 12 months from the United States, Canada, and Europe. WASHINGTON, DC — Hyman, Phelps & McNamara, P.C. is the largest dedicated food and drug law firm in the country.

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Controlled Substances Drug Pricing Drug Development 40

FDA Law Blog: Biosimilars

MAY 21, 2024

Houck — Last August Health and Human Services (“HHS”) recommended rescheduling marijuana from schedule I under the federal Controlled Substances Act (“CSA”) to schedule III. Schedules of Controlled Substances: Rescheduling of Marijuana, 89 Fed. 29, 2023) (“Basis”); NPRM at 44,603. By Larry K.

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Controlled Substances Chemotherapy Dosage Labelling 67

The Happy PharmD

APRIL 26, 2023

Dexamethasone oral solution is not a narcotic or controlled substance. In February 2023 she had her next to last refill of the prescription filled. At the beginning of March 2023, I stopped by the pharmacy and asked for the last refill of the Dexamethasone oral solution. This one baffled me.

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Dosage Hospitals Pharmacy Technician Prescription Filling 52

FDA Law Blog: Biosimilars

DECEMBER 21, 2023

Director Larry Houck will present a webinar on HHS’ cannabis rescheduling recommendation hosted by the National Association of State Controlled Substance Authorities (“NASCSA”) scheduled for Tuesday, January 9, 2024 at 3:00 pm (Eastern). Hyman, Phelps & McNamara, P.C.,

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Controlled Substances 52