Pharmacy Compounding Regulations The Genesis Of The Drug Quality And Security Act

925 words - 4 pages

Compounding is an important facet of pharmaceutics that allows the formulation of specific drugs for individual patients. The work done at compounding pharmacies permits the development of medicinal products for patients that cannot tolerate certain components from mass production pharmaceutical companies. These individuals may require uniquely compounded agents to be flavorless, preservative-free, dye-free, liquid, solid, or more. These specialty production facilities are necessary for therapy and an acceptable quality of life for individuals with specific needs. Recently, the patient-driven role of designer therapeutics that compounding pharmacies occupy was overshadowed when a manmade epidemic was produced a medical catastrophe when supposedly sterile materials were contaminated with infectious agents.1
In September 2012, a now defunct Massachusetts compounding pharmacy, the New England Compounding Center (NECC) synthesized over 17,000 contaminated steroid pain injections that were shipped to 23 states.2 Up to this point, the methylprednisolone acetate (MPA) injections compounded by the NECC have caused the death of 64 people and resulted in 751 cases of fungal meningitis in 11 states. With over 750 cases and still counting, the NECC outbreak is one the largest of healthcare-associated infections ever reported in the United States.3
In 2006, the NECC was under investigation by the Massachusetts pharmacy board and the FDA for numerous complaints. The investigation resulted in a 2006 consensus agreement that the NECC agreed to comply with. The NECC would avoid detrimental sanctions if they agreed to more stringent record-keeping and other procedures. Eight months before the outbreak in January 2012, through their wn monitoring, the NECC discovered pathogens in rooms designed to supply sterile vials. Neither the FDA or the state board could determine if the NECC had been able to rectify that particular problem. Both government agencies have said that they lacked the authority to enforce any type of effective action against the specialty pharmacy.4
In the wake of the NECC scandal, lawmakers attempted to extend the regulating power of the FDA over compounding pharmacies. Previously, compounding pharmacies straddled a line over being labelled drug manufacturers or simple mortar and pestle pharmaceutics. Since compounding pharmacies are not regarded as industrial manufacturers, their governing jurisdiction fell under the state.5 On November 27, 2013, President Obama ratified the Drug Quality and Security Act (DQSA), a body of laws that contains important provisions designed to grant greater oversight to the compounding of human drugs.6
The DQSA allows a compounding pharmacy to register with the FDA as an outsourcing facility. This facility would have to compound in compliance with Current Good Manufacturing Practice (CGMP) guidelines or under supervision of a licensed pharmacist in a registered facility. The facility would also be...

Find Another Essay On Pharmacy Compounding Regulations The Genesis of the Drug Quality and Security Act

Nimrod and Babylon: The Birth of Idolatry - Genesis 10:8-12; Genesis 3:15; Genesis 11

1055 words - 4 pages sun and of fire; other 'sky gods' would also be included. Therefore, Genesis 11:4, in speaking of "a tower and his top with the heavens (literal translation)," is not referring to the height of the tower, but instead to the inscriptions of the stars on the walls of the shrine. The constellations were there, but with outlines of the 'sky gods' on them in order to cause people to associate the 'pictures in the sky' that they had known about from

The Food Quality Protection Act of 1996

1457 words - 6 pages pesticide industry. This would been a major loss considering Congressman Bliley had been fighting for this reform legislation since the 102nd Congress (Sray 49 ). The Food Quality Protection Act of 1996 amends the Food Drug and Cosmetic Act and the Federal Insecticide, Fungicide, and Rodenicide Act that had been a burden to both growers and consumers. The bill Requires the Environmental Protection Agency to develop uniform standards in

The Anti-Drug Abuse Act of 1986

1311 words - 5 pages The Anti-Drug Abuse Act of 1986 [the Act] was enacted for several reasons. One of the provisions of the act was to introduce mandatory minimum sentences for individuals who are convicted of possessing a particular amount of crack cocaine and powder cocaine. Individuals convicted with possession of 5 grams of crack would receive a mandatory minimum of 5 years in prison. Individuals convicted with possession of 500 grams of powder cocaine would

The Value of Genesis

1220 words - 5 pages , and modern-day allusions contained within it can still apply to everyday life- even to those teenagers who feel disconnected from this book. To begin with, many stories in Genesis relate closely to books that exist today. In fact, some of them are actually based completely on the stories of Genesis and Genesis itself. For example, John Milton’s Paradise Lost is a classic epic that relates especially closely to a story in Genesis. It depicts an

Genesis and The Book of Mathew

1082 words - 4 pages 1.What does the story of Genesis tell us about the biblical view of the universe and humankind's place in it?The Book of Genesis tells of the beginning of the world and how God created it. It implies that God did not create the earth without form and empty. It became formless and empty. He created the heavens and the earth and this was perfect, because nothing imperfect can come from God. The universe was created by God's command. The story of

Comparing the Epic of Gilgamesh and Genesis

1427 words - 6 pages The Epic of Gilgamesh has many similarities to the Bible, especially in Genesis and it’s not just that the both begin with the letter “g”’! One major similarity being the flood story that is told in both works. The two stories are very similar but also very different. Another being the use of serpents in both works and how they represent the same thing. A third similarity being the power of God or gods and the influence they have on the people

Comparing Genesis and the Epic of Gilgamesh

1466 words - 6 pages the beginnings of their religious scripture, Genesis and Exodus, the first two parts of the Bible. Though set in different times, by different authors, for different beliefs and cultures, there are many evident parallels between The Epic of Gilgamesh and the Bible. The Bible borrowed many stories from The Epic of Gilgamesh to explain the events of the time before its writing. The well known tale of Adam and Eve has similarities with the epic

The Homeland Security Act

887 words - 4 pages …monitor connections between illegal drug trafficking and terrorism” among many other points of interest. The act gave powers to the Secretary that were to be carried out through the different subagencies (THOMAS). There are many that find that the act is too restrictive of the freedoms of citizens. For example, the American Civil Liberties Union (ACLU) provides cases of what they feel is the Homeland Security Act overstepping its bounds to

Title V of the Social Security Act

1708 words - 7 pages know about their sex life for the future. Sex education seems, after studies and debates, to be the most effective method in aiding these issues. In the fall of 2016, if democrats are in office then it will result in, passing the bill to amend title V of the Social Security Act to eliminate the abstinence-only education programs. Therefore, the billions of dollars of funding for abstinence- only programs currently could be used to improve sex

The Genesis of the Reformation

796 words - 4 pages The Reformation is a very essential part in the history of any Christian. The Reformation called for an examination of the church to bring it back to the principles established in the Bible. The cause of this challenge to the Catholic Church and its authority is not credited to the idea of a single person, but it is credited to several influential people. The Reformation did not occur suddenly, different factors set the Reformation in motion and

History and Laws behind the Federal Food and Drug Act of 1906

2048 words - 8 pages History and Laws behind the Federal Food and Drug Act of 1906 As one of the primary federal consumer-protection laws in existence today, The Federal Food and Drug Act of 1906 was a law that had two primary goals for food and drugs: (a) forbid harmful ingredients and additions and (b) demand labeling of ingredients to inform consumers. According to Janssen

Similar Essays

The Compounding Medicine Controversy Essay

1251 words - 6 pages ) and State Boards of Pharmacy oversee all compounding, with the Boards monitoring more. The FDA tends to work more with pharmaceutical companies to make sure what they are doing is legal. The United States Pharmacopeia (USP) has standards used every day that are “mandated by law” (“International Academy of Compounding.”). Due to the regulations, most compounding is seen in nuclear pharmacies, hospitals, and home health specialty locations

The Future Of Pharmacy Essay

959 words - 4 pages DEFINING PHARMACY Pharmacy is not only the act of dispensing medication and council to the customer on use, as I have learned from my first definition. It is a spectrum of definitions comprised in a single field going from broad to specialized as a new genre of health services. Pharmacy is also the chemical preparation, the mixture, the the administrative management of the HMC, which coordinates the physicians, and patients. Finally, to that,in

The Pure Food And Drug Act Of 1906

1732 words - 7 pages In 1906, the Pure Food and Drug Act, that was years in the making was finally passed under President Roosevelt. This law reflected a sea change in medicine-- an unprecedented wave of regulations. No longer could drug companies have a secret formula and hide potentially toxic substances such as heroin under their patent. The law required drug companies to specify the ingredients of medications on the label. It also regulated the purity and dosage

Case Study Of Two Organizations; Pharmacy Board Of Australia (Ahpra) And The Pharmacy Guild Of Australia

601 words - 3 pages Case study of human life and pharmacy organizations rule This case study about a Mrs. Freda Jenkins, a sixty-eight year old pensioner visits her General Practitioner (GP). Her blood pressure has been rising steady over the years, and therefore the (GP) gave her a medicine (script was in handwriting), at that time Mrs. Freda Jenkins went to a local pharmacy, the main story began from here, the pharmacy assistance gave a wrong medication to Mrs