Which of these is required for sterile compounding but not for non-sterile compounding?

The Poison Control Act of 1970 allows nasal inhalers to be dispensed without child-resistant containers.

On discovery of a theft of controlled sub- stances, the local law enforcement agency must be notified, and DEA Form 106 needs to be submitted.

The Controlled Substances Act allows for the partial filling of a Schedule III to V medication at the request of the patient. The remaining balance of medication can be dispensed only if the physician has indicated a refill on the prescription. The total number of units of medication or refills cannot exceed what is indicated on the prescription.

A manufacturer’s drug label is required to contain the manufacturer’s control (lot) number, expiration date of the medication, and NDC number for the medication. Other pieces of required information include the proprietary name if it is branded drug, the nonproprietary name, the quantity of medication in the package, and manufacturer’s name.

The FFDCA requires all products to include a list of ingredients, directions, and safety warnings. It also states that all drugs must be approved by the FDA prior to being marketed and used by patients. The FFDCA improved upon the Pure Food and Drug Act by adding the safety requirements that the Pure Food and Drug Act was missing. The Isotretinoin Safety and Risk Management Act of 2004 addresses the need for Risk Evaluation and Mitigation Strategy (REMS) criteria and specific monitoring of patients using medications with potentially serious adverse effects. The PPPA describes the security requirements for medication packaging to prevent children from accessing the medication.

Nitroglycerin is an example of a medications that does not need to be in a child-resistant container according to the Poison Control Act.

Pharmacies must keep records onsite of all prescriptions for a minimum of 2 years and they must be organized in such a way that they can easily be inspected by the DEA or state BOP. There are other relevant regulations to keep in mind, however: + Under federal law alone the prescription records should be kept for at least 5 years. See the last regulation, below. + The FDA has also stated that it will look at prescriptions records dating back 5 years. + Under the Medicare Modernization Act of 2003, prescriptions for Medicare are required to be retained for 10 years. + There is a different requirement for being kept in the pharmacy (onsite) versus being retained in general. There are a whole set of laws for central storage of prescriptions (and other pharmacy records) at an offsite location. Under this regulation, the pharmacy itself needs to retain records for at least 2 years onsite but a total of 5 years.