When glass vials, ampoules, or syringes are used as primary packaging in contact with a drug product, FDA may review them as part of the drug's container-closure system under the drug approval process. Importers of pharmaceutical-grade glassware should confirm with their regulatory affairs team whether the specific articles require FDA review, and consulting a licensed customs broker familiar with pharmaceutical imports is advisable.

Fused quartz and fused silica are made from nearly pure silicon dioxide and offer extremely high temperature resistance and UV transparency, making them suitable for semiconductor processing and high-temperature laboratory applications. Borosilicate glass contains boron trioxide, which lowers the thermal expansion coefficient and provides good chemical resistance at a lower cost, making it the standard for general laboratory and pharmaceutical glassware. The material composition and thermal expansion specification determine the correct subheading.