-
Categories
-
Pharmaceutical Intermediates
-
Active Pharmaceutical Ingredients
-
Food Additives
- Industrial Coatings
- Agrochemicals
- Dyes and Pigments
- Surfactant
- Flavors and Fragrances
- Chemical Reagents
- Catalyst and Auxiliary
- Natural Products
- Inorganic Chemistry
-
Organic Chemistry
-
Biochemical Engineering
- Analytical Chemistry
-
Cosmetic Ingredient
- Water Treatment Chemical
-
Pharmaceutical Intermediates
Promotion
ECHEMI Mall
Wholesale
Weekly Price
Exhibition
News
-
Trade Service
U.
S.
drug distributors urge the FDA to immediately revoke its guidelines for setting parameters for establishing electronic systems to trace products throughout the supply chain
.
The Distributors Trade Association stated that the FDA exceeded its statutory authority when seeking to obtain private electronic tracking information between trading partners
In June this year, the FDA issued a draft guidance on "Enhancement of Drug Distribution Security at the Packaging Level under the "Drug Supply Chain Security Act" in order to establish the requirements of the "Drug Supply Chain Security Act" (DSCSA) scheduled to be implemented on November 27, 2023.
The data architecture system required by the electronic interoperability system lays the foundation
.
[FDA releases four draft guidelines on drug supply chain safety issues 2021/06/04]
medical insurance
medical insurance The Healthcare Distribution Alliance (HDA), which represents US drug distributors, submitted 37 pages of feedback on the guidelines, citing “serious issues” in the guidelines
.
HDA stated that the draft guidance does not clearly clarify the basic requirements for 2023 compliance and is “inconsistent” with the system already implemented by the supplier
The guidelines stipulate that electronic tracking information should be provided to FDA and other state officials.
The guidelines state that “enhanced systems should allow FDA and other federal and state officials to communicate with various systems of trading partners and receive relevant information as required
.
” HDA disputed this provision, stating, “We are seriously concerned about the assumptions of the draft guidelines.
HDA also questioned the data architecture model proposed in the guide, which specifies how to store, manage, and integrate data between trading partners
.
These include centralized models, distributed models, or a mixture of centralized and distributed models
HDA also highlighted issues in other areas
.
HDA finally urged the FDA to immediately withdraw the draft guidance, and insisted that the “enhanced system” required by the guidance does not exist and is not intended to be established or implemented by Congress in DSCSA, even if the FDA has the right to implement such a system as described in the draft guidance.
McKesson
McKesson The FDA also received 11 feedbacks from drug manufacturers, pharmacy groups, dispensers, and drug distributors
.
McKesson, one of the three major drug procurement and distribution alliance members in the United States, agrees with HDA's opinion and also believes that the guidelines allow FDA to access electronic systems of trading partners beyond DSCSA's statutory intent
Boehringer Ingelheim
Boehringer Ingelheim The drug maker Boehringer Ingelheim’s feedback objected to a provision of the guidelines that required drug manufacturers to respond to notifications of recalls and illegal products within one day
.
The company stated that the FDA should allow more time if there is a problem with the electronic system
