Issue link: https://www.e-digitaleditions.com/i/1287521
6 September 2020 Tablets & Capsules markets Global cannabis capsule market to grow 17.9 percent annually MAHARASHTRA, India—The global cannabis capsule market is forecast to grow at a compound annual rate of 17.9 percent through 2021, according to a report from Data Bridge Market Research. Within the North American segment, the advancing legalization of cannabis for pharmaceutical and recreational use will drive market growth. Major mar- ket players mentioned in the report include Joy Organics, CBDistillery, Gaia Botanicals, Palmetto Harmony, Floyd's of Leadville, Lazarus Natu- rals, cbdMD, Pure Hemp Botanicals, Endoca, and Green Roads. Global particle size analysis market to reach $465.4 million by 2025 DUBLIN, Ireland—The global particle size analysis market will reach $465.4 million by 2025, rep- resenting a compound annual growth rate of 5.5 percent, according to a report by Research and Markets. Increasing research in nanotechnol- ogy, growing investments in phar- maceutical R&D, and rigorous prod- uct quality regulatory guidelines will drive market growth. Key market players include Malvern Panalytical, Horiba, Beckman Coulter, Micro- trac, Izon Science, Micromeritics, Shimadzu, Sympatec, Anton Paar, TSI, Bettersize Instruments, Fritsch, Brookhaven Instruments, LS Instru- ments, and AimSizer. industry news FDA proposes adding four and removing 19 substances from 503b bulk drug substances list SILVER SPRING, MD—The FDA has proposed adding four substances to the 503b bulk drug substances list, which specifies which substances outsourcing facilities may use in drug compounding. The proposed sub- stances are diphenylcyclopropenone, glycolic acid, squaric acid dibutyl ester, and trichloroacetic acid. The agency has also identified 19 bulk drug substances that it proposes to not include on the list based on the lack of clinical need for outsourc- ing facilities to use the substances for compounding drug products. The FDA is seeking public comment before finalizing the decision. FDA publishes guidances on unit-dose repackaging and cannabis compounds SILVER SPRING, MD—The FDA has published the final guidance, "Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products," which describes the conditions under which the agency will not act regarding required sta- bility studies for repackaged prod- ucts and assigned expiration dates. This guidance finalizes a revised draft guidance on the subject published in August 2017. The agency also issued the draft guidance "Cannabis and Canna- bis-Derived Compounds: Quality Considerations for Clinical Research, Guidance for Industry." This docu- ment responds to questions raised by stakeholders, including some raised during a public hearing held last year. Topics covered by the draft guidance include sources of cannabis for clinical research, information on quality considerations, recommen- dations for calculating THC levels, and key FDA regulatory concepts for stakeholders who may be unfamiliar with the FDA and its authorities. Purdue offers online pharmacy course WEST LAFAYETTE, IN—Begin- ning in August, Purdue University began offering an online course intended to prepare students apply- ing to the institution's professional p h a r m a c y p r o g r a m . T h e p h a r - macy orientation course covers the requirements for Purdue's profes- sional program, prepares students for the application process, and pro- vides basic pharmacy knowledge and skills. The online course is compara- ble to the in-person course offered to second-year preprofessional phar- macy students but includes new con- tent and has been redesigned with online learning in mind. UCI establishes pharmacy school IRVINE, CA—The University of California, Irvine (UCI) has estab- lished a School of Pharmacy and Pharmaceutical Sciences, the first public pharmacy school in the Los Angeles-Orange County region and one of the few California schools attached to an academic health cen- ter. The school comprises the exist- ing Department of Pharmaceutical Sciences and a new Department of Clinical Pharmacy Practice. The Doctor in Pharmacy program will begin accepting students in fall 2021. Companies release results of DSCSA pilot programs NEW YORK, NY and NORTH READING, MA—Merck, Walmart, IBM, and KPMG have published the results of their Drug Supply Chain Security Act (DSCSA) pilot proj- ect program, which summarizes the companies' creation and evaluation of a blockchain solution to track products across the supply chain and share that information between supply chain partners in one place. T h e F D A ' s D S C S A p i l o t p r o - gram selected various participants to explore and evaluate methods to enhance the safety and security of the drug supply chain. The four companies began their collabora- tion on the pilot program in March 2019 and found that their block- chain solution accurately recorded the location of the drug products across the supply chain; maintained data privacy; increased patient safety by alerting partners to drug prod- uct investigations and recalls and restricting shipping, receiving, and dispensing of the products subject to the alerts; and enhanced recall functionality. To read the full report, visit institutes.kpmg.us. Tracelink has also published the results of its DSCSA pilot program project, which studied, analyzed, and prepared recommendations on dig- ital networks to manage drug prod-