THE EVIRONMENTAL PROTECTION AGENCY (Cont'd)

• Enforces its findings through fines, sanctions, and other procedures.
• Runs programs to prevent, control, and respond to oil spills; control air pollution and forecast air pollution levels; and foster the manufacture of more fuel-efficient vehicles.
• Works to enforce laws such as the Clean Air Act, the Safe Drinking Water Act, the National Environmental Education Act, and the Clean Water Act.
• Is responsible for the detection and prevention of environmental crimes, monitoring pollution levels, and setting standards for the handling of hazardous chemicals and waste.

Differentiating Between "Medical Waste" and "Pharmaceutical Waste"

Pharmaceutical Waste:

• Is not one single waste stream, but many distinct waste streams that reflect the complexity and diversity of the chemicals that comprise pharmaceuticals.
• Pharmaceuticals are chemicals first and therapeutic agents second.
• Hazardous wastes are divided into two categories:
  • Listed wastes, and
  • Characteristic wastes.
• Listed wastes appear on one of four lists of hazardous waste (F, K, P, and U).
• Pharmaceuticals are on two of these lists: the P and U lists.
• Characteristics of hazardous drugs include:
  • Ignitability
  • Corrosivity
  • Reactivity
  • Toxicity
• P-listed wastes are commercial chemical products that are categorized as acutely hazardous under RCRA (Resource Conservation and Recovery Act).
• One of the primary criteria for the P-list as acutely hazardous is an oral lethal dose of 50 mg/kg (LD50) or less.
• Pharmaceutical waste is generated through many activities, including general compounding, IV preparation, spills/breakage, partial used vials, syringes and IVs, discontinued, unused preparations, patients' personal medications, outdated pharmaceuticals, and others.

Medical Waste:

Medical waste is a subset of wastes generated at healthcare facilities, such as hospitals, physicians' offices, dental practices, blood banks, and veterinary hospitals/clinics, as well as medical research facilities and laboratories. Generally, medical waste is healthcare waste that that may be contaminated by blood, body fluids, or other potentially infectious materials and is often referred to as regulated medical waste.

More next week.

News

Taro Pharmaceuticals Recalling Phenytoin Oral Suspension Due to Possible Under- or Overdosing
Taro is voluntarily recalling two (2) lots of Phenytoin Oral Suspension USP, 125 mg/5 mL both in 237-mL bottles, to the consumer level. It is packaged in amber plastic bottles with an inner seal and a white child-proof closure. The reason for the recall is that product from these two lots may not re-suspend when shaken, as instructed for administration, which could result in under- or overdosing. This recall is being conducted with the knowledge of the FDA.

The two (2) lots that are being recalled are as follows:

FDA Drug Safety Program is Adding Billions to US Healthcare Spending
[Note: Remember colchicine, ergotamine, quinine, and others?]

An FDA program intended to make sure all drugs on the market are safe and effective is unintentionally adding billions to U.S. healthcare spending, according to a new study cited by STAT.

In 2006, the FDA started a program called the Unapproved Drugs Initiative to force drugmakers to get regulatory approval for drugs they had on the market that were available on a grandfathered basis because they predated stricter requirements. Some drugmakers decided not to pursue regulatory approval, leaving open opportunities for monopolies that allowed some of them to hike their prices, according to STAT. The analysis found that the program may be adding $20.3 billion to U.S. healthcare spending.

Between 2013 and 2019, four drugmakers received FDA approval for drugs they already had on the market, and each found they had no competition because the manufacturers of the other versions of their drugs didn't seek regulatory approval. In three of the cases, the drugmakers were also granted different types of marketing exclusivity, and they raised the prices of their drugs between 525 percent and 1,644 percent, STAT reported.

An example of this occurred earlier this month, when Belcher Pharmaceuticals received orphan drug status for its version of dehydrated alcohol, a drug that has been available for years, and hiked the price by nearly 600 percent.

Vizient also pointed out 19 unapproved drugs on the market now that could potentially follow the same pattern, which would cause another $8.75 billion in healthcare spending in the next five years, according to STAT.
https://www.beckershospitalreview.com/pharmacy/fda-drug-safety-program-is-adding-billions-to-us-healthcare-spending.html

Did You Know ...

...that, especially during "campaigning season," we hear that we have a lot of "rights"? It seems like oftentimes politicians confuse "rights" with "privileges and opportunities." Also, along with the "rights," we have "responsibilities," which we will cover next week.

Tip of the Week

From the U.S. Department of Homeland Security:

Rights of an American Citizen:

• Freedom to express yourself.
  
  
• Freedom to worship as you wish.
  
  
• Right to a prompt, fair trial by jury.
  
  
• Right to vote in elections for public officials.
  
  
• Right to apply for federal employment requiring U.S. citizenship.
  
  
• Right to run for elected office.
  
  
• Freedom to pursue "life, liberty, and the pursuit of happiness."

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Looking Back

He's nifty and thrifty-
Looks 30 at 50!
     Burma-Shave