101.3—Biological products and related terms.
When used in conjunction with or in reference to a biological product, the following terms shall mean:
(a) Licensed biological product.
A biological product prepared within a licensed establishment by a person holding an unexpired, unsuspended, and unrevoked product license for such product.
(b) Experimental biological product.
A biological product which is being evaluated to substantiate an application for a product license or permit.
(c) Completed product.
A biological product in bulk or final container produced in compliance with the regulations to final form and composition.
(d) Finished product.
A completed product which has been bottled, sealed, packaged, and labeled as required by the regulations.
(e) Released product.
A finished product released for marketing after all requirements have been satisfactorily complied with.
(f) Fraction.
A specific antigen, its antibodies, or its antitoxin which constitutes a component of a biological product.
(g) Diluent.
A liquid used to rehydrate a desiccated product or a liquid used to dilute another substance.
(h) Serial.
The total quantity of completed product which has been thoroughly mixed in a single container and identified by a serial number: Provided, That, when all or part of a serial of liquid biological product is packaged as diluent for all or part of a serial of desiccated product, the resulting combination packages shall be considered a serial of the multiple fraction product.
(i) Subserial.
Each of two or more properly identified portions of a serial which are further processed at different times or under different conditions such as, but not limited to, being desiccated in different size final containers and/or at different times.
(j) Outline of production.
A detailed protocol of methods of manufacture to be followed in the preparation of a biological product and which may sometimes be referred to as an outline.
(k) Product Code Number.
A number assigned by Animal and Plant Health Inspection Service to each type of licensed biological product.
(l) Harvest date.
Unless otherwise specified in a filed Outline of Production, the harvest date shall be the date blood or tissues are collected for production or the date cultures of living microorganisms are removed from production incubators.
(m) Bacterin.
An inactivated bacterial product consisting of an antigenic suspension of organisms or particulate parts of organisms, representing a whole culture or a concentrate thereof, with or without the unevaluated growth products, which has been inactivated as demonstrated by acceptable tests written into the filed Outline of Production for the product.
(n) Toxoid.
An inactivated bacterial product which consists of a sterile, antigenic toxin or toxic growth product, which has resulted from the growth of bacterial organisms in a culture medium from which the bacterial cells have been removed, which has been inactivated without appreciable loss of antigenicity as measured by suitable tests, and which is nontoxic as demonstrated by acceptable tests written into the filed Outline of Production.
(1)
A suspension of organisms, representing a whole culture or a concentrate thereof, with the toxic growth products from the culture which has been inactivated without appreciable loss of antigenicity as measured by suitable tests, the inactivation of organisms and toxins being demonstrated by acceptable tests written into the filed Outline of Production: Provided, That it shall contain cellular antigens and shall stimulate the development of antitoxin; or
(2)
A combination product in which one or more toxoids or bacterin-toxoids is combined with one or more bacterins or one or more bacterin-toxoids.
(p) Bacterial extract.
An inactivated bacterial product which consists of the sterile, nontoxic, antigenic derivatives extracted from bacterial organisms or from culture medium in which bacterial organisms have grown.