Shapiro is fully programmed for all FDA filings and has been actively filing FDA though ACE for many months. So far, we have limited this to a subset of customers while FDA and CBP worked out technical and operational issues. Most of these issues have been resolved and Shapiro will be moving to full FDA filing via ACE in the next 30 to 60 days.
While a hard deadline has yet to be set to make FDA filing via ACE mandatory, it is coming and most certainly will be required before the end of the year. In regards to filings for FDA drugs, there are a few new data elements that were previously not required for filing FDA drugs. Below is a list and brief description of the new required elements for FDA drugs in ACE.
Our goal is to assure all of our customers are as prepared as possible, and that there are no delays in facilitating the release of their products. If you have any questions about these new requirements please reach out to your account coordinator for further information.
Brand Name: The brand name the drug is to be sold under
Deliver to Party: U.S. party that physically receives the goods
Agency Processing Code: Possible codes shown below
- Investigational
- Over the Counter
- Pharmaceutical Necessities
- Prescription
- Research & Development
Intended Use Code: Possible codes shown below depending on Agency Processing Code
| Prescription (PRE) | ||
| Finished Form |
080.000 | For Human Medical Use as a Non-Food Product under Controlled Distribution |
| Finished Form | 970.000 | Import for Export |
| Finished Form | 100.000 | Importation for Personal Use |
| Finished Form |
155.012 | Drug to be used as a constituent part in a Medical Device |
| Not Finished Form: Active Pharmaceutical Ingredient/Bulk Drug Substance |
150.007 |
For processing into a pharmaceutical product. |
| Not Finished Form: Active Pharmaceutical Ingredient/Bulk Drug Substance |
970.000 |
Import for Export |
| Not Finished Form: Active Pharmaceutical Ingredient/Bulk Drug Substance |
150.017 | Drug to be used as a component in a Medical Device |
| Over the Counter (OTC) | ||
| Finished Form | 130.000 | For Consumer Use as a Non-Food Product |
| Finished Form | 970.000 | Import for Export |
| Finished Form | 100.000 | Importation for Personal Use |
| Finished Form |
155.012 | Drug to be used as a constituent part in a Medical Device |
| Not Finished Form: Active Pharmaceutical Ingredient/Bulk Drug Substance |
150.007 |
For processing into a pharmaceutical product. |
| Not Finished Form: Active Pharmaceutical Ingredient/Bulk Drug Substance |
970.000 |
Import for Export |
| Not Finished Form: Active Pharmaceutical Ingredient/Bulk Drug Substance |
150.017 | Drug to be used as a component in a Medical Device |
| Pharmaceutical Necessities & Containers (PHN) | ||
| No intended use codes for this commodity sub-type. | ||
| Research and Development (INV) | ||
180.009 | Chemical for research and development in a pharmaceutical product – clinical trial or other human/animal use. | |
| Research and Development (RND) | ||
180.017 | Chemical for research and development in a pharmaceutical product – laboratory testing only, no human/animal use. | |
