Questions have been received from pharmacists concerning stability studies and beyond-use dates (BUDs) involving whether or not the same manufacturers' ingredients identical to those used in a stability study must be used in order to utilize a BUD from the stability study.

Any United States Pharmacopeia-National Formulary (USP-NF)-grade ingredient, regardless of manufacturer or lots within a manufacturer, must meet the identical compendial standards; so they are interchangeable. In fact, the official USP compounding formulas do not differentiate between ingredients from manufacturers or lot numbers. Also, when manufacturers develop a new drug product, the data is applied to future product for years and will be from different lots and may be from different manufacturers. (References below are to the current USP 39-NF 34, 2016.)

USP-NF-grade chemicals for both manufacturing and compounding must meet the same monograph standards to be used.

For support, the following is from the current USP-NF:

"A bulk substance may be referred to as an article, official substance, drug, active pharmaceutical ingredient, etc." (General Notice - Page 3).

"An official substance is a drug substance, excipient, dietary ingredient, other ingredient, or component of a finished device for which the monograph title includes no indication of the nature of the finished form" (General Notices - Page 3).

"A drug with a name recognized in USP-NF must comply with compendial identity standards or be deemed adulterated, misbranded, or both" (General Notices - Page 3).

"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 231 CFR 299.5[c]) (General Notices - Page 3).

"The standards in the relevant monograph�apply at all times in the life of the article from production to expiration. Every compendial article in commerce shall be so constituted that when examined in accordance with these assays and test procedures, it meets all applicable pharmacopeial requirements. Thus, any official article is expected to meet the compendial standards if tested, and any official article actually tested as directed in the relevant monograph must meet such standards to demonstrate compliance" (General Notices - Page 4).

"Official substances are prepared according to recognized principles of good manufacturing practice and from ingredients complying with specifications designed to ensure that the resultant substances meet the requirements of the compendial monographs" (General Notices - Page 4).

"A�drug substance�may use the designation "USP" or "NF" in conjunction with its official title or elsewhere on the label only when�(2) the article complies with the identity prescribed in the specified compendium" (General Notices - Page 4).

Note: An exception to the interchangeability of drug substances may include particle size/shape or some documented property that is necessary for a specific/unique dosage form. In this case, the alternate-sourced drug must still meet the same USP-NF specifications but may have a label with additional details.

Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition

News

Major Recall of Liquid Drugs, Supplements�Potential Bacterial Contamination
The following products should be discontinued immediately! PharmaTech announced a voluntary recall of all liquid products due to a potential risk of contamination with Burkholderia cepacia; if administered, infections can develop in patients with compromised immune systems and in patients with chronic lung conditions (e.g., cystic fibrosis). Some of these infections may be serious and/or life-threatening in patient populations that are at risk.

The recall impacts all liquid products from October 20, 2015 through July 15, 2016. Drug products affected by the recall include:

• Aller-chlor Antihistamine
• Diocto Syrup
• Docusate Sodium
• Ninjacof
• Ninjacof A
• Senexion Liquid
• Senna Syrup
• Sennazon Syrup
• Virtrate-2
• Virtrate-K

Additionally, various dietary supplement products from Rugby, Major, Bayshore, and Metron are impacted by the recall:

• Calcionate Syrup
• Cerovite Liquid
• CertaVite with Antioxidants
• CytoDetox
• D3 Vitamin Liquid
• D-Vita Drops
• Fer-iron Liquid
• Ferrous Drops
• Ferrous Sulfate Liquid
• Liquid Vitamin C
• Pedia D-Vite Drops
• Pedia Poly-Vite Drops
• Pedia Tri-Vite Drops
• Poly-Vita Drops
• Poly-Vita Drops with Iron
• Polyvitamin liquid
• Polyvitamin liquid with Iron
• Renew HC
• Tri-Vita Drops
• Tri-Vitamin liquid

The Company is notifying its distributors via a recall letter and is arranging for return of all recalled products.
http://www.empr.com/safety-alerts-and-recalls/major-recall-of-liquid-drugs-supplements-due-to-potential-bacterial-contamination/article/514987/

Shortages Causes the FDA to Allow Imports from 8 Companies Banned for Quality Shortcomings
Since the vast majority of drugs and drug ingredients are manufactured outside the U.S., the FDA has stepped up its international oversight and often bans products from plants that don't meet its standards. However, the FDA also has found itself increasingly having to walk a tightrope between drug safety and drug availability. Companies in China or India often are a primary source of essential drugs, and the FDA sometimes must exempt products and allow imports from plants that it believes have a poor record. In the past 3 to 4 years, the FDA has allowed 8 plants whose products are otherwise banned from the U.S. to go ahead and import some drugs or ingredients to avoid shortages.
http://www.fiercepharma.com/manufacturing/fda-allows-imports-from-8-banned-drug-plants-to-avoid-shortages

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Did You Know ...

�that, as mentioned in this Newsletter many times previously, it would be a totally different presidential campaign if all candidates were required to TELL THE TRUTH? Also, it would help if the media was required to TELL THE TRUTH!

Tip of the Week

It seems the media has an undue influence on elections. They give a lot of time to a few people with opinions (not necessarily facts) until many of the populace start believing that what they are hearing/seeing is the truth held by the majority!

Looking Back

A man, A miss,
A car-A curve,
He kissed the miss,
And missed the curve!
     Burma Shave