The DQSA Amends the Federal Food, Drug and Cosmetic Act (FFDCA) by Revising Section 503A and Adding a New Section 503B1,2
Among other provisions, sections 503A and 503B of the FFDCA generally prohibit:
Given the availability of FDA-approved hyaluronidase products like Hylenex® recombinant (hyaluronidase human injection), sections 503A and 503B of the FFDCA generally prohibit traditional compounding pharmacies and outsourcing facilities from supplying non-FDA approved hyaluronidase.1,2
As an FDA-Approved Drug, Hylenex Recombinant May, Without a Patient-Specific Prescription, Be:
- supplied to a clinician’s office or Ambulatory Surgery Center (ASC).
- supplied by any compounding pharmacy or outsourcing facility.
- purchased through all major drug wholesalers and distributors.
Hylenex® recombinant (hyaluronidase human injection) is an endoglycosidase indicated as an adjuvant to increase the dispersion and absorption of other injected drugs.
Important Safety Information:
Hylenex recombinant is contraindicated in patients with known hypersensitivity to hyaluronidase or any of the excipients in Hylenex recombinant. Discontinue Hylenex recombinant if sensitization occurs.
Warnings and Precautions
Spread of Localized Infection: Hyaluronidase should not be injected into or around an infected or acutely inflamed area because of the danger of spreading a localized infection.
Ocular Damage: Hyaluronidase should not be applied directly to the cornea. It is not for topical use.
Allergic reactions have been reported in less than 0.1% of patients receiving hyaluronidase. Anaphylactic-like reactions following retrobulbar block or intravenous injections have occurred, rarely.
The most frequently reported adverse reactions have been mild local injection site reactions, such as erythema and pain. Hyaluronidase has been reported to enhance the adverse reactions associated with co-administered drug products.
Furosemide, the benzodiazepines, products containing sodium metabisulfite (e.g. in local anesthetic products containing epinephrine) and phenytoin are incompatible with hyaluronidase.
Hyaluronidase should not be used to enhance the dispersion and absorption of dopamine and/or alpha agonist drugs.
When used with local anesthetics, hyaluronidase hastens the onset of analgesia and shortens its duration of effect, and increases the incidence of systemic reactions.
Patients receiving large doses of salicylates, cortisone, ACTH, estrogens or antihistamines may require larger amounts of hyaluronidase for equivalent dispersing effect.
Available by prescription only.
You may report an adverse event related to Hylenex recombinant by calling 1-877-877-1679. If you prefer, you may contact the FDA directly. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please see the Full Prescribing Information.
1. U.S. Food and Drug Administration. FD&C Act Chapter V: Drugs and Devices. www.fda.gov.
www.gpo.gov/fdsys/pkg/USCODE-2010-title21/html/USCODE-2010-title21-chap9-subchapV-partA-sec353a.htm. Accessed November 13, 2015.
2. U.S. Congress. Text H.R. 3204 –113th Congress: Drug Quality and Security Act. www.Govtrack.us
www.govtrack.us/congress/bills/113/hr3204/text. November 21, 2013. Accessed November 13, 2015.
3. U.S. Congress. Text H.R. 3204 –113th Congress: Drug Quality and Security Act. democrats.energycommerce.house.gov/sites/default/files/documents/HR-3204-Drug-Quality-Security-Act-One-Pager-2013-9-27.pdf. Accessed November 13, 2015.