Department of Labor
www.osha.gov

This newsletter, which discusses what happens after an OSHA inspection and the appeals process, is the third in a series on the topic of OSHA.

RESULTS:

When OSHA violations are found, whether related to OSHA standards or serious hazards, OSHA may issue citations and fines. If a citation and proposed penalty is issued, it must be done within six months of the violation's occurrence. The citation will list any proposed penalties and give a deadline for correcting the alleged hazards.

Violations are characterized as:

• Willful
• Serious
• Other-than-serious
• de minimis
• Failure to abate, and
• Repeated

OSHA has a policy of reducing penalties for small employers and those acting in good faith; they may also reduce the proposed penalty based on the gravity of the alleged violation for more serious violations. No good faith adjustment is made for alleged willful violations.

APPEALS:

If a citation is issued, the employer is offered an opportunity for an informal conference with the OSHA Area Director to discuss citations, penalties, abatement dates, or any other aspect of the inspection. A settlement may be worked out within this conference as the primary goal of OSHA is correcting hazards and maintaining compliance rather than issuing citations or collecting penalties.

Alternatively, employers have 15 working days to formally contest the alleged violations and/or penalties by sending a written notice to the Area Director. Any citations, penalties, and abatement dates that are not challenged or settled becomes a final order of the OSHA Commission.

Next week, we will look at some general aspects of OSHA.

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

IACP News

IACP is Now APC!

No, APC is not "Aspirin, Phenacetin, and Caffeine" for those that remember it from years past. "APC" is the new name for the "Alliance for Pharmacy Compounding", the new name for the International Academy of Compounding Pharmacists (IACP)!

USP 2nd Level Appeal set for January

The hearing dates on the appeal of beyond-use date (BUD) restrictions in the new USP <795> and <797> chapters are suggested to occur on January 21-22. After the initial appeal by IACP, Innovation Compounding and Wedgewood was denied by the USP Compounding Pharmacy Expert Committee in August. IACP (APC) requested an appeal hearing as provided for in the USP bylaws. At the January 21-22 hearing, IACP and its partners will be allowed two hours to present to an appeals panel selected to include relevant scientific and USP process expertise. The appellants may present both process and scientific arguments relevant to the BUD restrictions in the new chapters. In light of the appeals, the USP in September indefinitely postponed enforcement of the new chapters.

General News

Amazon Launches Medication Management Features for Alexa
As Amazon continues to move into the healthcare market, it is rolling out a medication management feature for Alexa owners. The feature allows customers to set up their own medication reminders and request voice refills using their prescription information. Initially, these capabilities are only available to customers of Giant Eagle Pharmacy, a regional retailer in the Midwest and East Coast.

There are obvious ties to Amazon's larger plans with regard to prescription management and healthcare. Amazon has now acquired two health startups, PillPack and Health Navigator which will become a part of Amazon's pilot healthcare service program for its employees, the recently launched Amazon Care.
https://techcrunch.com/2019/11/26/amazon-launches-medication-management-features-for-alexa/

Walgreens Opens First VillageMD Site
Chicago-based primary care company VillageMD is celebrating the opening November 20 of its first primary care clinic at a Walgreens store in Houston, the company announced on Twitter. The VillageMD primary care clinic, called Village Medical at Walgreens, is the first of five sites to open in Houston. Four more clinics are slated to open by the end of the year. The Village Medical clinics are located next to Walgreens stores and offer services including annual preventive care, women's health services, vaccinations, diagnostic testing, smoking cessation, chronic care management, and some specialty care. The clinics offer same-day, walk-in appointments, as well as house calls and virtual visits. The clinics are staffed by primary care physicians, nurses, pharmacists, and social workers.
https://www.beckershospitalreview.com/hospital-physician-relationships/walgreens-opens-first-villagemd-site.html

The FDA Comes Down Hard Against CBD-infused Foods and Beverages
This week the FDA issued warning letters to 15 companies for illegally selling products containing CBD, saying they had violated the Federal Food, Drug and Cosmetic Act. At the same time, the FDA published a revised Consumer Update detailing broad safety concerns about CBD products.

Bottom line: The federal government has not concluded that CBD is "generally recognized as safe" (GRAS) for use in human or animal food. Thus, CBD in food and drink is still illegal.
https://www.washingtonpost.com/business/2019/11/27/fda-comes-down-hard-against-cbd-infused-food-beverage-ending-months-silence/

Did You Know ...

...that the following anonymous statement was made?

"Just once I would like to read a medication label that says:

WARNING - May cause permanent weight loss, remove wrinkles and increase energy."

Tip of the Week

We can all dream, but I wonder if it would ever be approved by the FDA.

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Looking Back

The time to start,
A real dispute,
Is when you're offered,
A substitute!
     Burma-Shave

Don't Forget
Alternatives to USP Chapters for State Boards of Pharmacy is Available Online

At the CompoundingToday.com website "Homepage," there is an option to access "Alternatives to USP <795>, <797>, and <800>" documents. These documents are easily modifiable, bullet-point versions in Microsoft Word for use by State Boards of Pharmacy (SBOP) to prepare their own regulations.

It is easier and more convenient for SBOPs to "customize" the chapters and make them more appropriate and specific for their individual states and to ensure patient access to medications, both manufactured and compounded.

Once these have been modified and approved, they can be incorporated into the regulations of the state and can be easily updated as needed by the SBOP. They will be controlled by the SBOP and not by a national entity.