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By Diane L. Darvey Pharm.D. J.D.
In an easy, hassle-free variety, the felony instruction manual for Pharmacy Technicians teaches pharmacy technicians the necessities on how pharmacy is regulated
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Sample text
There are exceptions to the child-resistant packaging requirement. Consumers may ask the pharmacist to dispense their prescription in non-child-resistant packaging. On prescriptions, medical practitioners may ask for non-child-resistant packaging for their patients. In such instances, pharmacists are permitted to dispense the drugs in non-child resistant containers. In addition, some prescription drugs are exempt from child-resistant packaging because it is not appropriate, feasible, or practical.
For instance, the state Board may have authority over the dispensing of prescription medications in a physician’s office. This additional authority varies greatly from state to state. Nearly every year, Boards of Pharmacy issue new regulations or modify existing regulations to keep pace with changes in the practice of pharmacy. State Boards of Pharmacy have different sources to provide information on new and proposed Chapter 2 • Development of Laws and Rules or Regulations 25 regulation changes.
FDA classifies recalls into three categories, as shown in Table 3-2. Key Point FDA has authority to request or order that a drug be recalled from the market due to quality or safety concerns. 34 Legal Handbook for Pharmacy Technicians Table 3-2 FDA Drug Product Recalls Class I Dangerous or defective drug that could cause serious health problems Class II Drug that may cause a temporary health problem or threat of a serious problem Class III Drug is unlikely to cause a health problem, but may violate FDA labeling or manufacturing regulations Drug recalls may involve recalling certain “batches” of a drug product or recalling all of a drug product.