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. Helpful practitioner prescribing guidance is set forth in a simplified document here. By Karla L. 21 U.S.C. § 21 U.S.C. § 802(54)(D)(i).

Controlled Substances 59

Controlled Substances FDA Documentation Labelling 59

The Thyroid Pharmacist

JULY 29, 2022

Perhaps more concerning, of the 133 different VOCs found across all tested products, only one, ethanol, was actually listed on any label! (13, For sunscreens and other over-the-counter drugs, fragrances must be identified on the label. But formaldehyde has been labeled as a known human carcinogen by the U.S.

Health and Personal Care Stores 52

Health and Personal Care Stores Compounding Immunization Labelling 52

The Thyroid Pharmacist

DECEMBER 7, 2022

Several years ago, after reading research about all of the toxins commonly used in flame retardants (and learning about all of the many products in my home that contain these chemicals… somewhat of a shocking list), I looked at my mattress label, only to learn it contained one of the chief offenders. Labels (Furniture, Fabrics, and Carpet).

Health and Personal Care Stores 55

Health and Personal Care Stores Labelling Immunization Compounding 55

ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” Published June 2008. If elements such as these are adopted during the revision of ICH M4Q, this could influence global regulatory agencies to eliminate the requirement for custom Module 2 commitment documents. The authors propose using Module 2.3

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” Published June 2008. If elements such as these are adopted during the revision of ICH M4Q, this could influence global regulatory agencies to eliminate the requirement for custom Module 2 commitment documents. The authors propose using Module 2.3

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

AUGUST 30, 2022

The Common Technical Document (CTD) for the Registration of Pharmaceuticals For Human Use: Quality—M4Q guidance covers the minimum requirements for submission of raw materials; however, certain regions have additional requirements. The absence of any of the listed documentation should be scientifically justified.

Documentation 52

Documentation FDA Packaging Communication 52