Hemp Production Program Comment Period Reopened – The U.S. Department of Agriculture (USDA) is providing an additional 30 days for public comments on the interim final rule that established a domestic hemp production program under the Agriculture Improvement Act of 2018. The interim final rule outlines provisions for the USDA to approve plans submitted by states and Indian tribes for the domestic production of hemp. After receiving more than 4,600 comments, additional comments on specific topics are requested.
FDA Published Study on Difficult-to-Make Prescription Drugs – The study, titled “Quality Testing of Difficult-to-Make Prescription Pharmaceutical Products Marketed in the US,” found that all 252 drug products the FDA sampled met the U.S. market standards for the major quality attributes of dosage unit uniformity and dissolution. However, there is evidence of differences in the consistency of these attributes between regions and manufacturers.
Carcinogen Found in Antibacterial Drugs Used to Treat Tuberculosis – Nitrosamine impurities were found in certain samples of rifampin and rifapentine. However, the FDA announced that it will not object to certain manufacturers temporarily distributing rifampin containing 1-methyl-4-nitrosopiperazine (MNP) or rifapentine containing 1-cyclopentyl-4-nitrosopiperazine (CPNP) above the acceptable intake limits until they can reduce or eliminate the impurities.
FDA Issued Guidance on Nitrosamine Impurities – This guidance follows recent findings of nitrosamine impurities, which are probable human carcinogens, in drugs such as angiotensin II receptor blockers, ranitidine, nizatidine, metformin and rifampin. This guidance recommends risk assessments for potential nitrosamines in any pharmaceutical product at risk for their presence. The FDA outlines steps manufacturers of active pharmaceutical ingredients and drug products should take to detect and prevent unacceptable levels of nitrosamine impurities in pharmaceutical products.
FDA Announces Virtual Public Meeting on MDUFA – The public meeting “Medical Device User Fee Amendments for Fiscal Years 2023 Through 2027” will now be held on Oct. 27 by webcast only. The purpose of this public meeting is to discuss proposed recommendations for the reauthorization of the Medical Device User Fee Amendments (MDUFA) for fiscal years 2023 through 2027. Interested participants may register; those wishing to present must register by Sept. 28.
Submission Deadline for Deemed Tobacco Products Passed – On Sept. 9, premarket review applications for many new tobacco products were due. The deeming rule took effect on Aug. 8, 2016, and makes e-cigarettes and all other electronic nicotine delivery systems (ENDS), cigars, pipe tobacco, nicotine gels, hookah tobacco and any future tobacco products subject to many of the regulatory and statutory requirements applicable to manufacturers of cigarettes, smokeless tobacco, cigarette tobacco and roll-your-own tobacco. Deemed products that met the definition of a new tobacco product and were on the market as of Aug. 8, 2016, were required to submit premarket review applications by Sept. 9.
California Legislature Passes Bill to Produce Drugs – This bill would require the California Health and Human Services Agency to enter into partnerships to produce or distribute generic prescription drugs and at least one form of insulin. The governor has until Sept. 30 to sign or veto the measure.
DEA Issues Interim Final Rule on Cannabis Compounds – The interim final rule codifies in the Drug Enforcement Administration (DEA) regulations the statutory amendments to the Controlled Substances Act (CSA) made by the Agriculture Improvement Act of 2018 (AIA). In 2018, the AIA excluded hemp from the definition of marijuana. Hemp now means that if the delta-9-tetrahydrocannabinol concentration is less than 0.3 percent on a dry-weight basis, the Cannabis sativa L. plant and any part of that plant are not controlled substances under the CSA. The interim final rule also codifies the removal of the Schedule V control for FDA-approved products containing cannabidiol.
DEA Proposed Quotas for 2021 – The proposed 2021 aggregate production quotas and assessment of annual needs are intended to represent the quantities of schedules I and II controlled substances and the List I chemicals ephedrine, pseudoephedrine and phenylpropanolamine necessary to provide for the estimated medical, scientific, research and industrial needs of the United States; lawful export requirements; and the establishment and maintenance of reserve stocks. The Drug Enforcement Administration considers many factors in proposing quotas, one of which is information from other government agencies. Interestingly, the FDA predicts levels of medical need for the United States will decline on average 36.52 percent for calendar year 2021. Public comments are due Oct. 1.