Lesson 5 Coding Drugs, Drug Products and Biologics
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Pharmaceutical Necessities and ContainersPharmaceutical Necessities and Containers for Drugs and Biologics - Industry Code 55
Pharmaceutical Necessities and Containers for Drugs and Biologics ClassesProducts that are considered Pharmaceutical Necessities or Containers for Drugs and Biologics are coded under Industry Code 55. There is a unique set of Subclass codes for these products. Although no Process Indicator Codes are used in this Industry by FDA OASIS and FACTS users, filers must transmit a dash "-" on the PIC field. The Product Code Builder Application will return a dash automatically.
The Pharmaceutical Necessities or Containers for Drugs and Biologics Classes
The Class codes for Industry 55 are listed in the table below. A few sample products are also provided to further define the class code.
CLASS |
NAME |
PRODUCT EXAMPLES |
A |
Closure |
Products in this Industry Class would be those that are N.E.C. (not elsewhere classified) |
B |
Coating (Closure/ Container) |
Products in this Industry Class are coatings for closures and containers that are N.E.C. (not elsewhere classified) |
C |
Non-Metallic Container/ Material |
Glass, acrylic, polyvinyl, etc. |
D |
Metallic Container/ Material |
Steel, stainless steel, and metallic containers that are N.E.C. (not elsewhere classified) |
E |
Additive in Plastic |
These are natural (rubber) or synthetics. Stabilizers, accelerators, anti-oxidant, colorant, etc. |
P |
Pharmaceutical Necessity (Mfr) |
The number of products in this category is very large and is split into three parts – P, Q, and R This Industry Class consists of chemicals, flavors, excipients, etc., used for making drugs. |
Q |
Pharmaceutical Necessity (Mfr) |
Same as P |
R |
Pharmaceutical Necessity (Mfr) |
Same as R |
Y |
Pharmaceutical Necessity (Mfr) & Container N.E.C. |
This Industry Class is for products not elsewhere classified. |
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The Pharmaceutical Necessities and Containers for Drugs and Biologic Products Subclasses The Subclasses for products under Industry Code 55 describes the form of the product.
SUBCLASS |
NAME |
A |
Closure Liners and Seals |
B |
Coatings for Closures |
C |
Coatings for Containers |
F |
Plastic – Natural (rubber) |
G |
Plastic - Synthetic |
P |
Pharmaceutic Necessity |
Y |
Not Elsewhere Classified (N.E.C.) |