Regarding the glycerin promoted by this post: It should be OK for vaping if it has an expiration date of longer than 18 months. After opening the USP seal I would recommend using all of the product before 18 months has elapsed.
Dear Mr. (XXXXXXXX),
Thank you for your questions. This has been forwarded to me since I am the Technical Services Manager responsible for queries relating to the USP-NF Excipient monographs under the Excipient Expert Committee. Here is some information that may help answer your question. The USP-NF has a section titled “General Notices” and this section presents the basic assumptions, definitions, and default conditions for the interpretation and application of the United States Pharmacopeia (USP) and the National Formulary (NF). Requirements stated in the General Notices apply to all articles recognized in the USP and NF (the “compendia”) and to all general chapters unless specifically stated otherwise. Where the requirements of an individual monograph differ from the General Notices or a general chapter, the monograph requirements apply and supersede the requirements of the General Notices or the general chapter, whether or not the monograph explicitly states the difference.
With this being stated, sections 2.30 and 3.20 of the UDP-NF General Notices states the following (bolded for ease of readability):
2.30. Legal Recognition
The USP and NF are recognized in the laws and regulations of many countries throughout the world. Regulatory authorities may enforce the standards presented in the USP and NF, but because recognition of the USP and NF may vary by country, users should understand applicable laws and regulations. In the United States under the Federal Food, Drug, and Cosmetic Act (FDCA), both USP and NF are recognized as official compendia. A drug with a name recognized in USP–NF must comply with compendial identity standards or be deemed adulterated, misbranded, or both. See, e.g., FDCA § 501(b) and 502(e)(3)(b); also FDA regulations, 21 CFR § 299.5(a&b). To avoid being deemed adulterated, such drugs must also comply with compendial standards for strength, quality, and purity, unless labeled to show all respects in which the drug differs. See, e.g., FDCA § 501(b) and 21 CFR § 299.5(c). In addition, to avoid being deemed misbranded, drugs recognized in USP–NF must also be packaged and labeled in compliance with compendial standards. See FDCA § 502(g).
A dietary supplement represented as conforming to specifications in USP will be deemed a misbranded food if it fails to so conform. See FDCA § 403(s)(2)(D).
Enforcement of USP standards is the responsibility of FDA and other government authorities in the U.S. and elsewhere. USP has no role in enforcement.
and
3.20. Indicating Conformance
A drug product, drug substance, or excipient may use the designation “USP” or “NF” in conjunction with its official title or elsewhere on the label only when (1) a monograph is provided in the specified compendium and (2) the article complies with the identity prescribed in the specified compendium.
When a drug product, drug substance, or excipient differs from the relevant USP or NF standard of strength, quality, or purity, as determined by the application of the tests, procedures, and acceptance criteria set forth in the relevant compendium, its difference shall be plainly stated on its label.
When a drug product, drug substance, or excipient fails to comply with the identity prescribed in USP or NF or contains an added substance that interferes with the prescribed tests and procedures, the article shall be designated by a name that is clearly distinguishing and differentiating from any name recognized in USP or NF.
A medical device, dietary supplement, or ingredient or component of a medical device or dietary supplement may use the designation “USP” or “NF” in conjunction with its official title or elsewhere on the label only when (1) a monograph is provided in the specified compendium and (2) the article complies with the monograph standards and other applicable standards in the compendium.
The designation “USP” or “NF” on the label may not and does not constitute an endorsement by USP and does not represent assurance by USP that the article is known to comply with the relevant standards. USP may seek legal redress if an article purports to be or is represented as an official article in one of USP's compendia and such claim is determined by USP not to be made in good faith.
The designation “USP–NF” may be used on the label of an article provided that the label also bears a statement such as “Meets NF standards as published by USP,” indicating the particular compendium to which the article purports to apply.
When the letters “USP,” “NF,” or “USP–NF” are used on the label of an article to indicate compliance with compendial standards, the letters shall appear in conjunction with the official title of the article. The letters are not to be enclosed in any symbol such as a circle, square, etc., and shall appear in capital letters.
If a dietary supplement does not comply with all applicable compendial requirements but contains one or more dietary ingredients or other ingredients that are recognized in USP or NF, the individual ingredient(s) may be designated as complying with USP or NF standards or being of USP or NF quality provided that the designation is limited to the individual ingredient(s) and does not suggest that the dietary supplement complies with USP standards.
Therefore, if you find glycerin labeled “USP Glycerin”, one could assume it has met the it the strength, quality, or purity, as determined by the application of the tests, procedures, and acceptance criteria set forth in the glycerin monograph and this has been deemed approved by the regulatory agency. Now, food grade glycerin should be labeled as FCC Glycerin and should meet the necessary requirements set forth in the FCC (Food Chemical Codex).
Please let me know if I can be of any further assistance.
“This response has been provided for informational purposes only, and should not be construed as an official interpretation of USP text or relied on to demonstrate compliance with USP standards or requirements.”
Regards,
(XXXXXXXXX)
United States Pharmacopeia (USP)
Documentary Standards Division
12601 Twinbrook Parkway
Rockville, MD 20852-1790
Phone: 301-816-8335
Fax: 301-816-8373
Email: [xxxxxl]
Alternate email:
xxxxx@usp.org
web:
U.S. Pharmacopeial Convention
