Table of Contents
- 1 Can nurses compound medications?
- 2 Is reconstitution considered compounding?
- 3 Can a RN order labs?
- 4 What is the difference between USP 797 and USP 800?
- 5 What is CEP approval?
- 6 Can you compound for office use?
- 7 Do compounding pharmacies follow the same regulations as drug manufacturers?
- 8 Can all pharmacies compound?
- 9 What’s the difference between a GMP and a cGMP?
- 10 What happens if a drug violates the cGMP?
Can nurses compound medications?
Neither the pharmacy law nor the nursing law prohibits a licensed health care practitioner with prescriptive authority from directing a RN or LPN to compound medications for the practitioner’s patient. It is a recognized and long-accepted practice for nurses to compound medications.
Is reconstitution considered compounding?
The FDA states that “Compounding does not include mixing, reconstituting, or similar acts that are performed in accordance with the directions contained in approved labeling provided by the product’s manufacturer and other manufacturer directions consistent with that labeling” [21 USC 321 (k) and (m)].
What is the difference between pharmaceutical compounding and drug manufacturing?
Pharmaceutical manufacturing is the process used to formulate and create commercially-available drugs. Unlike compounding, manufacturing creates drugs in pre-set formulas or doses on an industrial scale. Often, pharmaceutical manufacturing companies generate millions of doses or formulas per year.
Can a RN order labs?
Most likely, as an RN you cannot administer medications or order treatments and lab work without an order from a physician who has seen the patient. Advanced practice nurses can order medications, order treatments and lab work — based on their scope of practice as defined by the state nurse practice act.
What is the difference between USP 797 and USP 800?
The purpose of USP 797 is a general protection of sterile compounds and spaces from contamination. USP 800 expands controls for the protection of workers and environments against hazardous drug compounds.
How long does a CEP last?
After assessment, the EDQM may send queries to the applicant. When they are resolved, the EDQM sends the applicant a CEP, which is valid for 5 years from the date of first issue and valid indefinitely following the 5-year renewal.
What is CEP approval?
The Certification of Suitability (CEP) is a certificate that certifies compliance of the active pharmaceutical ingredients (API) or pharmaceutical ingredients with that of the rules laid down in the monograph of the European Pharmacopoeia (EP).
Can you compound for office use?
2 of this guidance, some compounded drug products are kept as office stock/ for office use by hospitals, clinics, or health care practitioners to administer to patients who present with an immediate need for a compounded drug product.
Can you compound a commercially available product?
19 FDA interprets this to mean that, in order to be compounded in accordance with section 503A, a drug product that is essentially a copy of a commercially available drug product cannot be compounded regularly – i.e., it cannot be compounded at regular times or intervals, usually, or very often.
Do compounding pharmacies follow the same regulations as drug manufacturers?
Compounding pharmacies, like drug manufacturers, have to follow the same regulations, such as those pertaining to a manufacturing process in a controlled environment. A manufacturing environment, for any drug product, must demonstrate control of the manufacturing process—suppliers, cleanliness, personnel, etc.
Can all pharmacies compound?
While most pharmacies offer some level of compounding, most compounding is done in pharmacies that have made the investment in equipment and training to do so safely and efficiently. Of the approximately 56,000 community-based pharmacies in the United States, about 7,500 pharmacies specialize in compounding services.
What is cGMP in the pharmaceutical industry?
Understanding Current Good Manufacturing Practices (cGMP) in the pharmaceutical industry can, at first, seem like trying to pick up a handful of water. It’s a broad concept that is hard to hold together.
What’s the difference between a GMP and a cGMP?
At the most basic level, GMP stands for Good Manufacturing Practice and cGMP stands for current Good Manufacturing Practice. The cGMP acronym originated in the USA, where the US Food and Drug Administration (FDA) wanted to impress upon drug manufacturers the need for continuous improvement in their approach to product quality.
What happens if a drug violates the cGMP?
The impact of CGMP violations depends on the nature of those violations and on the specific drugs involved. A drug manufactured in violation of CGMP may still meet its labeled specifications, and the risk that the drug is unsafe or ineffective could be minimal.
When was the last time the cGMP was published?
The latest cGMP was published in 2016, the Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients. This 58-page document provided some excellent updates to prior cGMP for the industry, but it also sparked more questions than it answered in the eyes of many pharmaceutical organizations.