"To qualify for exemptions under section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act), a drug product must be compounded by a licensed pharmacist or physician who does not compound regularly or in inordinate amounts any drug products that are essentially copies of a commercially available drug product, among other conditions."

Please note that this Guidance does NOT apply to:

• drugs compounded for use in animals,
• biological products subject to licensure in a biologics license application, or
• repackaged drug products

This guidance provides the FDA's policies regarding this provision of section 503A, including the terms:

• Commercially available
• Essentially a copy of a commercially available drug product, and
• Regularly or in inordinate amounts

"Essentially a copy of a commercially available drug product" does NOT include a drug product in which there is a change, made for an identified individual patient, which produces for that patient a significant difference, as determined by the prescribing practitioner, between the compounded drug and the comparable commercially available drug".

The FDA intends to determine:

• whether a compounded drug product is essentially a copy of a commercially available drug product and, if it is,
• the FDA intends to determine whether the drug product was compounded regularly or in inordinate amounts.

The FDA does NOT consider a drug product to be commercially available if it:

• has been discontinued and is no longer marketed, or
• appears on the FDA drug shortage list in effect designated "currently in shortage" status and not in "resolved" status in FDA's drug shortage database.

More next week!

A complete copy of this Guidance is available at:

https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatory
Information/Guidances/UCM510154.pdf

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

Japanese Active Pharmaceutical Ingredient Company Daito Kasei Kogyo Warned and Some Products Banned
An active pharmaceutical ingredient maker in Osaka, Japan, whose slogan is "Happiness, Awe and Surprise" is now on a growing list of Japanese pharmaceutical companies criticized by the FDA in warning letters. In addition, the FDA was sufficiently concerned to also ban products from the company's Okayama plant from the U.S. until it makes changes in its manufacturing.

Reasons included:

• The facility wasn't meeting even minimal GMP standards.
• The facility was releasing its drugs without first testing ingredients for identity and assay.
• The company said their former QC manager stated that testing wasn't needed if "identification tests of raw materials were confirmed" by the certificate of authentication [COA] from raw material manufacturers.
• The plant was falsifying its own COAs sent to its customers by signing off on them without doing all the required tests.

https://www.fiercepharma.com/manufacturing/fda-warns-api-maker-daito-kasei-kogyo-bans-its-products

Did You Know ...

�the following quote from Cowboy Ethics?:

"Let's face it ~ these last few years haven't been the easiest of times. But, on days when things seem especially rough, I think about what it must have been like on the open range in the middle of a blizzard, and I tell myself, 'Cowboy up'"!

Tip of the Week

As compounding pharmacists, we have gone through a LOT over the past 20 years. We have had our share of professional hardships, setbacks, and disappointments�BUT, we don't have to work outside in a blizzard! Probably 99+% of compounding pharmacists are doing an outstanding job of obeying laws and regulations, meeting required standards, and taking care of their patients. However, there are a few, as in any profession (e.g., medicine, law) that are the "takers and grabbers" and "go for the big bucks" regardless of the costs. By breaking laws and regulations and not adhering to appropriate standards, they eventually get caught. But the worst thing is they impact ALL compounding pharmacists in the nation because of their selfishness, ego, and inconsiderateness!

Probably the best way to combat this is to report and follow up any wrongdoing to the state boards of pharmacy and insist that something be done! Just think where we would be today without Walnut Creek Pharmacy, NECC, and many others that have placed an unfair burden on all compounding pharmacists, especially if the state boards of pharmacy and the FDA would have done their jobs correctly over the past 20 years.

It's much easier to prevent adverse effects on the profession than it is to change them after new laws and regulations have been put into place by the government(s), especially when they were not doing their job in the first place! As the quote above says, "Cowboy up"! By this, I mean get involved (Cowboy up!) both personally and financially to help your patients and prescribers by keeping compounded pharmaceuticals available to all, not just those in larger population centers.

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Looking Back

At school zones,
Heed instructions!
Protect our little,
Tax deductions!
     Burma Shave