Oregon Secretary of State

Oregon Health Authority

Health Licensing Office, Board of Direct Entry Midwifery - Chapter 332

Division 26
LEGEND DRUGS AND DEVICES

332-026-0000
Access to and Administration of Legend Drugs and Devices

(1) An LDM is prohibited from purchasing or administering legend drugs and devices, until the continuing education listed in OAR 332-020-0010 has been completed and attestation submitted to the Office upon renewal.

(2) Pursuant to ORS 687.493, an LDM who completes the continuing education listed in OAR 332-020-0010 is authorized to purchase and administer legend drugs and devices listed in OAR 332-026-0010, 332-026-0020, and 332-026-0030.

(3) An LDM must comply with all local, state and federal laws and regulations regarding the administration, distribution, storage, transportation and disposal of legend drugs and devices listed in OAR 332-026-0010, 332-026-0020, 332-026-0030.

(4) Approved legend drugs must be inventoried and securely stored when the product is not in use, including samples or any remaining portion of a drug.

(5) Records regarding approved legend drugs and devices must be maintained for five years. Records must be kept on the business premises and available for inspection upon request by the Office. Upon request by the Board or Office an LDM must provide a copy of records. Records must include, but are not limited, to the following:

(a) Name of drug, amount received, date of receipt, and drug expiration date;

(b) Name of drug and to whom it was administered; date and amount of drug administered to client;

(c) Name of drug, date and place or means of disposal.

(6) Expired, deteriorated or unused legend drugs must be disposed of in a manner that protects the LDM, client and others who may come into contact with the material during disposal.

(7) An LDM is required to obtain education and training before administering or purchasing any legend drug or device.

(8) An LDM is not required to administer and purchase any legend drugs or devices.

Statutory/Other Authority: ORS 676.615 & ORS 687.793
Statutes/Other Implemented: ORS 687.793
History:
DEM 1-2023, amend filed 04/28/2023, effective 05/01/2023
DEM 3-2019, amend filed 12/19/2019, effective 01/01/2020
DEM 2-2015, f. & cert. ef. 7-1-15
Renumbered from 332-025-0030 by DEM 5-2011, f. & cert. ef. 9-26-11
DEM 6-2010, f. 12-30-10, cert. ef. 1-1-11
DEM 1-2004, f. 6-29-04, cert. ef. 7-1-04
DEM 1-2002, f. 2-25-02 cert. ef. 3-1-02
DEM 1-2001(Temp), f. & cert. ef. 10-1-01 thru 3-29-02

332-026-0010
Approved Legend Drugs For Maternal Use

An LDM may administer the following legend drugs as approved by the Board for maternal use:

(1) Anti-Hemorrhagics for use by intramuscular injection includes:

(a) Synthetic Oxytocin (Pitocin, Syntocin and generic);

(b) Methylergonovine (Methergine); or

(c) Ergonovine (Ergotrate);

(2) Anti-Hemorrhagics by intravenous infusion is limited to:

(a) Synthetic Oxytocin (Pitocin, Syntocin, and generic); or

(b) Tranexamic acid.

(3) Anti-Hemorrhagics for oral administration is limited to:

(a) Methylergonovine (Methergine);

(b) Misoprostol (Cytotec).

(4) Anti-Hemorrhagics for rectal administration is limited to Misoprostol (Cytotec).

(5) Resuscitation is limited to medical oxygen and intravenous fluid replacement.

(6) Intravenous fluid replacement includes:

(a) Lactated Ringers Solution;

(b) 0.9% Saline Solution;

(c) D5LR (5% Dextrose in Lactated Ringers); or

(d) D5W (5% Dextrose in water).

(7) Anaphylactic treatment by subcutaneous injection is limited to Epinephrine.

(8) Local anesthetic includes:

(a) Lidocaine HCl (1% and 2%) (Xylocaine and generic);

(b) Topical anesthetic;

(c) Procaine HCl (Novocain, benzocaine, cetacane and generic); and

(d) Sterile water papules.

(9) Rhesus Sensitivity Prophylaxis is limited to Rho(d) Immune Globulin (RhoGAM, Gamulin Rh, Bay Rho-D and others).

(10) Tissue adhesive (Dermabond or generic).

(11) Intravenous antibiotics for Group B Streptococcal prophylaxis is limited to the following and is only to be used solely for the purpose of Group B Streptococcal prophylaxis:

(a) Penicillin;

(b) Ampicillin;

(c) Cefazolin; or

(d) Clindamycin.

Statutory/Other Authority: ORS 676.615 & ORS 687.493
Statutes/Other Implemented: ORS 687.493
History:
DEM 1-2023, amend filed 04/28/2023, effective 05/01/2023
DEM 3-2019, amend filed 12/19/2019, effective 01/01/2020
DEM 2-2015, f. & cert. ef. 7-1-15
Renumbered from 332-025-0040 by DEM 5-2011, f. & cert. ef. 9-26-11
DEM 1-2011(Temp), f. & cert. ef. 4-4-11 thru 9-27-11
DEM 6-2010, f. 12-30-10, cert. ef. 1-1-11
DEM 1-2004, f. 6-29-04, cert. ef. 7-1-04
DEM 1-2002, f. 2-25-02 cert. ef. 3-1-02
DEM 1-2001(Temp), f. & cert. ef. 10-1-01 thru 3-29-02

332-026-0020
Approved Legend Drugs For Neonatal Use

An LDM may administer the following legend drugs as approved by the Board for neonatal use:

(1) Eye Prophylaxis for disease of the newborn is limited to Erythromycin Ophthalmic (0.5%) Ointment (Ilotycin, AK-Mycin and generics).

(2) Prophylaxis for hemorrhagic disease of the newborn for oral use is limited to Mephyton.

(3) Prophylaxis for hemorrhagic disease of the newborn for intramuscular injection includes:

(a) AquaMephyton; and

(b) Konakion.

(4) Resuscitation is limited to medical oxygen.

Statutory/Other Authority: ORS 676.615 & ORS 687.493
Statutes/Other Implemented: ORS 687.493
History:
DEM 3-2019, amend filed 12/19/2019, effective 01/01/2020
Renumbered from 332-025-0050 by DEM 5-2011, f. & cert. ef. 9-26-11
DEM 6-2010, f. 12-30-10, cert. ef. 1-1-11
DEM 1-2004, f. 6-29-04, cert. ef. 7-1-04
DEM 1-2002, f. 2-25-02 cert. ef. 3-1-02
DEM 1-2001(Temp), f. & cert. ef. 10-1-01 thru 3-29-02

332-026-0030
Approved Devices

An LDM may use the following Board approved devices:

(1) Devices for injection of medications including:

(a) Needles.

(b) Syringes.

(2) Devices for administration of intravenous fluids including:

(a) Drip sets.

(b) Catheters.

(3) Devices for maternal and neonatal resuscitation including:

(a) Suction devices;

(b) Oxygen-delivery devices.

(c) Bag-Valve-Mask-Sets.

(4) Devices for rupturing the amniotic sac.

(5) Devices for repairing the perineal area including:

(a) Sutures;

(b) Instruments for completing a repair.

(c) Local anesthetic administration devices.

Statutory/Other Authority: ORS 676.615 & ORS 687.493
Statutes/Other Implemented: ORS 687.493
History:
DEM 3-2019, amend filed 12/19/2019, effective 01/01/2020
Renumbered from 332-025-0060 by DEM 5-2011, f. & cert. ef. 9-26-11
DEM 6-2010, f. 12-30-10, cert. ef. 1-1-11
DEM 1-2002, f. 2-25-02 cert. ef. 3-1-02
DEM 1-2001(Temp), f. & cert. ef. 10-1-01 thru 3-29-02