Pharmacy Law Blog

APRIL 20, 2018

To learn more about the status of marijuana, click here to read one of my prior blogs and be sure to check our Marijuana Law Blog regularly for updates. We can properly draft and complete the applications for registration, permitting and/or licensing, while complying with Florida law. In 2015 there were zero.

Doctors 40

Doctors Federal Policy Licensing Public Health 40

Provider Trust

JULY 26, 2023

These directories allow patients to connect with healthcare providers and licensed practitioners to make appointments, find and exchange information, and pay for services. It’s no wonder insurers end up spending as much as $2.1 billion annually to maintain overly-complicated, inaccurate databases.

Medicaid 52

Medicaid Medicaid Compliance Medicare 52

Hall Render

AUGUST 1, 2022

CMS is also proposing that REHs may provide outpatient services that are not otherwise paid under the OPPS (such as services paid under the Clinical Lab Fee Schedule) as well as post-hospital extended care services furnished in a unit of the facility that is a distinct part of the facility and licensed as a skilled nursing facility.

Hospitals 40

Hospitals Payment Systems Medicare Medicare 40

Provider Trust

MAY 18, 2022

In January 2015, the OIG settled for $96,259 with a Minnesota Pharmacist, Joseph C. This action was in addition to the 2018 settlement and sought these additional actions alleging that the clinics named in the complaint suffered significant gaps in licensing and supervision of therapists during the relevant time period.

Compliance 52

Compliance Due Diligence Medicaid Medicaid 52

SQA

JUNE 10, 2021

Commission in March 2015 after the publication, in December 2014, of the Q3D Guideline on Elemental Impurities (EI) by the International Council for Harmonization (ICH). Guidance on the Licensing of Biosimilar Products, 06 May 2021. This guidance applies to: Licensed manufacturers in Australia. 10 May 2021.

FDA 52

FDA COVID-19 COVID-19 Vaccine Compliance 52

Total HIPAA

JUNE 2, 2020

In this blog post, we have selected some of the most popular ones. Until 2015, Dropbox was not a HIPAA compliant solution, not because their security standards were not strong enough, but because they refused to provide a BAA. Organizations can save or reuse licenses. This list does not review all the products available.

HIPAA 52

HIPAA Compliance Licensing Regulatory Compliance 52

SQA

SEPTEMBER 2, 2022

With the previous version of the Guide dating back to 2015, it was clear that a substantial overhaul of the text would be necessary to incorporate the technical progress and new policies that have been adopted in the intervening years.

FDA 91

FDA COVID-19 Nursing Homes Compliance 91

SQA

FEBRUARY 15, 2023

This important revision presents the latest thinking on good manufacturing practices for excipients, and while the fundamental principles of GMP remain the same, the guide has been revised to align with ISO 9001:2015 requirements.

US Department of Health and Human Services 40

US Department of Health and Human Services FDA COVID-19 World Health 40

SQA

OCTOBER 18, 2023

In a 2015 survey, the overall prevalence of mineral supplement or vitamin use among Canadian men and women was 38% and 53%, respectively. In Canada, mineral supplements are regulated as natural health products (NHPs) under the Natural Health Products Regulations. These products are widely used by Canadians.

FDA 40

FDA Compliance Licensing World Health 40

Drug & Device Law

JULY 31, 2023

We have blogged several times about the somewhat esoteric issue of whether intangible items – chiefly computer software, website algorithms, and other electronic information – is treated as a “product” for purposes of imposing strict liability on their creators. 135 (Winter 2015) (citation and quotation marks omitted). 1145, 1165 n.135

Governance 52

Governance Payment Systems Hospitals Licensing 52

Drug & Device Law

DECEMBER 29, 2023

This year’s Drug & Device Law Blog top ten decisions of the year reinforced preemption – the most powerful defense we can assert. Equally bad, Hrymoc effectively read a New Jersey statute, §2A:58C-5(c), which precludes punitive damages where a “device” was “licensed” by the FDA, out of existence. We gave kudos to Kampmann here.

FDA 105

FDA US Department of Health and Human Services COVID-19 Informed Consent 105

Drug & Device Law

JUNE 2, 2022

For this post, however, all seven authors of the Blog are joining together. From its founding, the Blog has been addressing plaintiff attacks on medications and devices for contraception, state attempts to limit medical options for abortion, and other legal disputes affecting women’s health issues. Strickland , 531 F.3d Herzog , 788 F.3d

FDA 127

FDA Licensing 127

Drug & Device Law

FEBRUARY 20, 2023

Without an FDA license to produce another design, [defendant] was legally prohibited from distributing either [alternative design advocated by plaintiffs] at the time [plaintiff] received her vaccinations. 0295, 2015 WL 5022618, at *12 (N.J. As we’ve said many times before, the Blog does not do the other side’s research for them.

FDA 59

FDA Licensing Hospitals Governance 59

Drug & Device Law

NOVEMBER 9, 2023

In addition to its recent revamp of its “§510(k)” substantial equivalence clearance process for medical devices, (see our post here ), the FDA has also been active with respect to off-label communications – another regulatory area of continuing interest to this Blog. IMS Health Inc. , 552 (2011); Thompson v. 357 (2002); United States v.

FDA 64

FDA Health Insurance Nurses Medicare 64

Drug & Device Law

MARCH 7, 2022

Thus, Bexis made a note to blog on it – but only after he finished his chapter update due at the end of February. It does not give him license to evade the less rigid ? It does not, however, give a plaintiff “license to evade the less rigid ? 2015 WL 3466517 (D. 2015); Tapia v. 2015 WL 6828660, at *8 (S.D.

Fraud 59

Fraud FDA Licensing Pharmaceutical Industry 59