We Have The Answers
Pharmaceutics is the discipline of pharmacy that deals with the process of turning a new chemical entity (NCE) or old drugs into a medication to be used safely and effectively by patients. It is also called the science of dosage form design. There are many chemicals with pharmacological properties, but need special measures to help them achieve therapeutically relevant amounts at their sites of action. Pharmaceutics helps relate the formulation of drugs to their delivery and disposition in the body.
Pharmaceutics deals with the formulation of a pure drug substance into a dosage form .
The new law allows an entity that compounds sterile drugs to register as an outsourcing facility. Once registered, an outsourcing facility must meet certain conditions in order to be exempt from the FDCA’s approval requirements and the requirement to label products with adequate directions for use. Under the new law, the drugs must be compounded in compliance with CGMP by or under the direct supervision of a licensed pharmacist in a registered facility (section 503B(a)). The outsourcing facility must also report specific information about the products that it compounds, including a list of all of the products it compounded during the previous six months, and information about the compounded products, such as the source of the ingredients used to compound (section 503B(3)). In addition, the outsourcing facility must meet other conditions described in the new law, including reporting adverse events and labeling its compounded products with certain information (section 503B(b)(5) and section 503B(a)(10)).
Under the new law, an outsourcing facility will not be considered registered until it has paid the applicable annual registration fee (see section 744K(g)(3)(A)). An outsourcing facility may register without paying a fee until September 30, 2014, however, because fees are not required until October 1, 2014. In addition, the new law requires that outsourcing facilities register and report their products to FDA electronically unless the Secretary grants a request for a waiver of such requirement because use of electronic means is not reasonable for the person requesting the waiver (section 503B(b)). FDA has issued draft guidances on registering and reporting for those entities that intend to register as outsourcing facilities.
Non-Sterile Compounding Techniques
Despite the name, non-sterile compounding methods are safe. This technique has been used by Compounding pharmacy pharmacists for hundreds of years. It refers to the practice of preparing a specific medication for a patient to swallow in pill form, apply as a topical treatment to their skin or insert the medication under their skin. Although this practice is considered to be non-sterile, it is still performed in a closely monitored environment and under the applications of very strict rules and professional guidelines. The medications are customized according to legal standards that ensure that every pharmaceutical that is used in the medication maintains the proper ingredient potency and purity standards. In addition to creating customized medications that adhere to the industry’s and the law’s strict standards, non-sterile Compounding pharmacists are also responsible for making sure their mixtures are pure and accurate, that they provide proper labels and medication packages and that they maintain a clean working environment.
The major distinction that separates non-sterile compounding techniques and sterile compounding techniques actually has to do with how the medicine will be administered, rather than how it is compounded. Sterile compounding techniques are used to create customized medications that will either be directly injected into the patient or will be inserted into their eye. These medications carry a high risk of infection or other medical problems, so they are compounded according to sterile rules and regulations. This is due to the fact any bacteria or fungi that are allowed to get into the medication could seriously endanger the patient’s life. Sterile compounding practices ensure that all injectable medications and any applications that will be made directly to the eye will be fully sterile and free from even tiny amounts of bacteria or fungi. Sterile compounding usually takes place in a completely clean environment, such as a cleanroom. The pharmacists who are responsible for compounding the Sterile Medication will also wear appropriate safety gear including clothing, face and hair coverings.
A cream is an emulsion of oil and water in approximately equal proportions. It penetrates the stratum corneum outer layer of skin well. Cream is thicker than lotion, and maintains its shape when removed from its container. It tends to be moderate in moisturizing tendency. For topical steroid products, oil-in-water emulsions are common. Creams have a significant risk of causing immunological sensitization due to preservatives. It has a high rate of acceptance by patients. There is a great variation in ingredients, composition, pH, and tolerance among generic brands
Gels are thicker than a solution. Gels are often a semisolid emulsion in an alcohol base. Some will melt at body temperature. Gel tends to be cellulose cut with alcohol or acetone. Gels tend to be drying. Gels tend to have greatly variable ingredients between generic brands and trade names. Gels carry a significant risk of inducing hypersensitivity due to fragrances and preservatives. Gel is useful for the scalp and body folds. In applying gel one should avoid fissures and erosions due to the drying and stinging effect of the alcohol base. Gel enjoys a high rate of acceptance due to its cosmetic elegance.
FDA responds to potential drug shortages by taking actions to address their underlying causes and to enhance product availability. FDA determines how best to address each shortage situation based on its cause and the public health risk associated with the shortage.
For manufacturing/quality problems, FDA works with the firm to address the issues. Problems may involve very low risk (e.g. wrong expiration date on package) to high risk (particulate in product or sterility issues). Regulatory discretion may be employed to address shortages to mitigate any significant risk to patients.
FDA also works with other firms making the drugs that are in shortage to help them ramp up production if they are willing to do so. Often they need new production lines approved or need new raw material sources approved to help increase supplies. FDA can and does expedite review of these to help resolve shortages of medically necessary drugs. FDA can’t require the other firms to increase production.
When a shortage occurs and a firm has inventory that is close to expiry or already expired, if the company has data to support extension of the expiration dating for that inventory, FDA is able to review this and approve the extended dating to help increase supplies until new production is available.
When the US manufacturers are not able to resolve a shortage immediately and the shortage involves a critical drug needed for US patients, FDA may look for a firm that is willing and able to redirect product into the U.S. market to address a shortage. FDA considers a list of criteria to evaluate the product to ensure efficacy and safety. These criteria include the formulation and other attributes of the drug as well as the quality of the manufacturing site where the drug is made.
FDA works to find ways to mitigate drugs shortages; however, there are a number of factors that can cause or contribute to drugs shortages that are outside of the control of FDA.
Also, FDA issued a long-term strategic plan to outline the agency’s priority actions, as well as actions drug manufacturers and others can take, to prevent drug shortages by promoting and sustaining quality manufacturing.
Medicines play an important role in treating many conditions and diseases, but when they are no longer needed it’s important to dispose of them properly to avoid harm to others. Below, we list some disposal options and some special disposal instructions for you to consider when throwing out expired, unwanted, or unused medicines.
Medicine Take-Back Programs
Medicine take-back programs for disposal are a good way to remove expired, unwanted, or unused medicines from the home and reduce the chance that others may accidentally take the medicine. Contact your city or county government’s household trash and recycling service to see if there is a medicine take-back program in your community and learn about any special rules regarding which medicines can be taken back. You can also talk to your pharmacist to see if he or she knows of other medicine disposal programs in your area or visit the U.S. Drug Enforcement Administration’s website for information on National Prescription Drug Take-Back Events.
Disposal in Household Trash
If no medicine take-back program is available in your area, you can also follow these simple steps to dispose of most medicines in the household trash:
- Mix medicines (do NOT crush tablets or capsules) with an unpalatable substance such as kitty litter or used coffee grounds
- Place the mixture in a container such as a sealed plastic bag; and
- Throw the container in your household trash
- Before throwing out your empty pill bottle or other empty medicine packaging, remember to scratch out all information on the prescription label to make it unreadable
In order to establish an account with us, certain forms must be filled out and kept on file. You can email us at email@example.com to request the forms. Please include your company name, contact person, telephone number, email address and the state(s) you are operating in – or, call our toll-free number at 888-983-2520.
Couldn’t find the answer?
We welcome your questions. Please drop us a note and we will get back to you shorly.