Subsection B – Labelling requirements for prescription medicinal products and/or insulin § 201.50 – Declaration of identity. § 201.51 – Declaration of net content. § 201.55 – Indication of dosage. § 201.56 – Requirements for the content and form of the labelling of prescription human and biological drugs. §201.57 – Specific requirements for the content and format of the labeling of prescription human drugs and biologics in accordance with 201.56(b)(1). § 201.58 – Exemption from labelling requirements. Subdivision C – Non-prescription Drug Labelling Requirements § 201.60 – Main Billboard. § 201.61 – Declaration of identity. § 201.62 – Net Content Declaration. § 201.63 – Warning against pregnancy/breastfeeding. § 201.64 – Sodium labelling. § 201.66 – Requirements for the format and content of the labelling of nonprescription drugs. § 201.70 – Labelling of calcium.
§ 201.71 – Magnesium labelling. § 201.72 – Marking of potassium. § 201.80 – Specific requirements for the content and format of the labelling of prescription human and biological drugs; older drugs not described in 201.56(b)(1). Subsection G – Special labelling requirements for certain medicinal products § 201.300 – Notice to manufacturers, packers and distributors of glandular preparations. § 201.301 – Notice to manufacturers, packers and distributors of estrogenic hormonal preparations. § 201.302 – Notice to manufacturers, packers and distributors of drugs for internal use containing mineral oil. § 201.303 – Labelling of medicinal preparations containing significant quantities of wintergreen oil. § 201.304 – Tannic acid and barium enema preparations. § 201.305 – Preparations for inhalation of isoproterenol (pressurized aerosols, nebulizers, powders) intended for human consumption; Warnings.
§ 201.306 – Potassium salt preparations for oral ingestion by humans. § 201.307 – sodium phosphates; Limitation of package sizes, warnings and instructions for stationary sales. § 201.308 – Ipecac syrup; Warnings and instructions for use for stationery sales. § 201.309 – preparations containing acetophenidine (phenacetin); Warning message required. § 201.310 – phenindone; Labelling of medicinal preparations intended for human use. § 201.311 – [Reserved] § 201.312 – Magnesium sulfate heptahydrate; Declaration of labelling of medicinal products. § 201.313 – Labelling of estradiol. § 201.314 – Labelling of medicinal preparations containing salicylates. § 201.315 – Over-the-counter medications for mild sore throats; Suggested warning. § 201.316 – Drugs for human use with hormonal thyroid activity; Warning required. § 201.317 – Digitalis and related cardiotonic drugs for human use in oral dosage form; Warning required.
§ 201.319 – Water-soluble gummies, hydrophilic gums and hydrophilic muciloids (including, but not limited to, gelagasis, alginic acid, calcium polycarbophile, sodium carboxymethylcellulose, carrageenan, chondrus, glucomannan (B-1,4-bound polymannose acetate), guar gum, karaya gum, algae, methylcellulose, plantain (psyllium) seeds, polycarbophilic tragacanth and xanthan gum) as active ingredients; required warnings and instructions. § 201.320 – Warnings for drugs containing or manufactured with chlorofluorocarbons or other ozone-depleting substances. § 201.323 – Aluminum in large and small parenteral plants used throughout parenteral nutrition. § 201.325 – Over-the-counter medications for vaginal contraception and for the use of spermicides containing nonoxynol 9 as an active ingredient; required precautionary statements and labelling information. § 201.326 – Over-the-counter drugs containing internal analgesic/antipyretic active ingredients; warnings and other required markings. § 201.327 – Over-the-counter sunscreen; Required labeling based on efficacy testing. § 201.328 – Marking of medical gas containers. Appendix A to Part 201 – Examples of Graphic Enhancements Used by FDA Subpart A – General Labelling Requirements § 201.1 – Drugs; Name and registered office of the manufacturer, packer or distributor.
§ 201.2 – Drugs and devices; National Drug Code Numbers. § 201.5 – Drugs; Adequate instructions for use. § 201.6 – Drugs; misleading statements. § 201.10 – Drugs; Indication of ingredients. § 201.15 – Drugs; Highlighting the required instructions on the label. § 201.16 – Drugs; Spanish version of some required instructions. § 201.17 – Drugs; The location of the expiration date. § 201.18 – Drugs; Meaning of control numbers. § 201.19 – Drugs; Use of the term „infant“. § 201.20 – Declaration of the presence of FD&C Yellow No. 5 and/or FD&C Yellow No.
6 in certain medicinal products for human use. § 201.21 – Declaration of the presence of phenylalanine as a component of aspartame in over-the-counter and prescription drugs for human use. § 201.22 – Prescription drugs containing sulphites; Warnings required. § 201.23 – Pediatric studies required. § 201.24 – Labelling of systemic antibacterial drugs. § 201.25 – Requirements for barcoded labels. § 201.26 – Exceptions or alternatives to the labelling requirements for human drugs held by the National Strategic Stockpile. Q. What information must be included on the recipe label? The practice of the profession of pharmacist is defined as the manufacture, preparation, storage or dispensing of medicines, medicinal products and therapeutic devices on the basis of prescriptions or other legal authority and the collaborative management of pharmacotherapy in accordance with the provisions of section sixty-eight hundred a-a of this article. The Management Board shall issue regulations exempting from any labelling requirement medicinal products, devices and cosmetics which, in accordance with commercial practice, are to be processed, labelled or repackaged in significant quantities in establishments other than those in which they were originally processed or packaged, provided that such medicinal products, appliances and cosmetics are not falsified in accordance with the provisions of this Article.
when they are removed from this processing, or be mislabelled. Labelling or repackaging. §6800. Introduction | §6801 Definition of pharmacy practice | §6801-a. Collaborative Drug Therapy Management Demonstration Program| §6802 Definitions | §6803.